GELFOAM
Report
- Report Number
- 1810189-2019-00003
- Event Type
- Injury
- Date Received
- February 20, 2019
- Report Date
- January 22, 2019
- Manufacturer
- PFIZER, INC. (DEVICE)
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
REASONABLY SUGGEST DEVICE MALFUNCTION: YES. SEVERITY OF HARM: S4. FAILURE MODE: UNKNOWN. IDC - LEVEL 1: QUALITY. IDC - LEVEL 2: PRODUCT COMPLAINT. IDC - LEVEL 3: COMPLAINT - FUNCTION / THERAPEUTIC PROPERTIES. QA REVIEW & RATIONALE: THE HAZARD ANALYSIS WITHIN THE RISK MANAGEMENT FILE HAS BEEN REVIEWED USING THE COMPLIANT NARRATIVE AND ASSOCIATED DOCUMENTATION FOR HAZARDS/HAZARDOUS SITUATIONS, AND THEIR ASSOCIATED SEVERITIES. THE REVIEW DETERMINED THAT THE HAZARD/HAZARDOUS SITUATION AND SEVERITY WAS S4; THEREFORE, THE COMPLAINT IS INDICATIVE OF A POTENTIALLY REPORTABLE DEVICE COMPLAINT. THE DETAILS OF THE COMPLAINT HAVE BEEN ESCALATED TO PFIZER US SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. ADDITIONALLY, DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE MEDICAL DEVICE COMBINATION PRODUCT (MDCP) TEAM FOR EVALUATION. THE COMPLAINT, ITS PRIORITY, AND ITS CLASSIFICATION HAVE BEEN REVIEWED AND DETERMINED TO BE APPROPRIATE. NO IMMEDIATE CONTAINMENT ACTION IS REQUIRED. AN INVESTIGATION WILL BE PERFORMED. IMPACT TO THE DEVICE: POSSIBLE ADVERSE EVENT. MALFUNCTION IS PRESENT IN THIS CASE. HAZARDOUS SITUATION: DIMINISHED/ALTERED PRODUCT FUNCTION. HAZARD NUMBER (WORST CASE): H10-07. SEVERITY (WORST CASE): S4. A REVIEW OF PREVIOUS MDR FOUND SIMILAR CASES REGARDING LACK OF EFFECT.
REASONABLY SUGGEST DEVICE MALFUNCTION: YES. SEVERITY OF HARM: FAILURE MODE: UNKNOWN. IDC - LEVEL 1: QUALITY. IDC. LEVEL 2: PRODUCT COMPLAINT. IDC - LEVEL 3: COMPLAINT - FUNCTION / THERAPEUTIC PROPERTIES. QA REVIEW & RATIONALE: THE HAZARD ANALYSIS WITHIN THE RISK MANAGEMENT FILE HAS BEEN REVIEWED USING THE COMPLIANT NARRATIVE AND ASSOCIATED DOCUMENTATION FOR HAZARDS/HAZARDOUS SITUATIONS, AND THEIR ASSOCIATED SEVERITIES. THE REVIEW DETERMINED THAT THE HAZARD/HAZARDOUS SITUATION AND SEVERITY WAS S4; THEREFORE, THE COMPLAINT IS INDICATIVE OF A POTENTIALLY REPORTABLE DEVICE COMPLAINT. THE DETAILS OF THE COMPLAINT HAVE BEEN ESCALATED TO PFIZER US SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. ADDITIONALLY, DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE MEDICAL DEVICE COMBINATION PRODUCT (MDCP) TEAM FOR EVALUATION. THE COMPLAINT, ITS PRIORITY, AND ITS CLASSIFICATION HAVE BEEN REVIEWED AND DETERMINED TO BE APPROPRIATE. NO IMMEDIATE CONTAINMENT ACTION IS REQUIRED. AN INVESTIGATION WILL BE PERFORMED. IMPACT TO THE DEVICE: POSSIBLE ADVERSE EVENT. MALFUNCTION IS PRESENT IN THIS CASE. HAZARDOUS SITUATION: DIMINISHED/ALTERED PRODUCT FUNCTION. HAZARD NUMBER (WORST CASE): H10-07. SEVERITY (WORST CASE): S4. A REVIEW OF PREVIOUS MDR FOUND SIMILAR CASES REGARDING LACK OF EFFECT. THE HAZARD ANALYSIS WITHIN THE RISK MANAGEMENT FILE HAS BEEN REVIEWED USING THE COMPLIANT NARRATIVE AND ASSOCIATED DOCUMENTATION FOR HAZARDS/HAZARDOUS SITUATIONS, AND THEIR ASSOCIATED SEVERITIES. THE REVIEW DETERMINED THAT THE HAZARD/HAZARDOUS SITUATION AND SEVERITY WAS S4; THEREFORE, THE COMPLAINT IS INDICATIVE OF A POTENTIALLY REPORTABLE DEVICE COMPLAINT. ROOT CAUSE: PFIZER (SITE NAME) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (SITE NAME) PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT.
AS A FINAL MEASURE TO STOP THE BLEEDING, TOPICAL BOVINE THROMBIN (THROMBINE-JMI, PFIZER, CITY NAME) WAS APPLIED TO ARREST THE HEMORRHAGING, BUT TO NO AVAILABLE [DRUG INEFFECTIVE]. CASE NARRATIVE: THIS LITERATURE REPORT IS BASED ON THE JOURNAL OF THE IMPLANT DENTISTRY, (YEAR 2012) VOL 21(5): (PGS. 368-373) ENTITLED [BRISK, PULSATILE BLEEDING FROM THE ANTERIOR MANDIBULAR INCISIVE CANAL DURING IMPLANT SURGERY: A CASE REPORT AND USE OF AN ACTIVE HEMOSTATIC MATRIX TO TERMINATE ACUTE BLEEDING.] A 69-YEAR-OLD MAN WAS TREATMENT PLANNED FOR THE EXTRACTION OF THE 3 REMAINING MANDIBULAR ANTERIOR TEETH FOLLOWED BY IMMEDIATE IMPLANT PLACEMENT OF 4 DENTAL IMPLANTS TO SUPPORT A COMPLETE OVERDENTURE AND BAR. THE PATIENT'S MEDICAL HISTORY WAS UNREMARKABLE AND NEGATIVE FOR COAGULOPATHIES. HE WAS NOT PRESCRIBED ANY MEDICATIONS AND DENIED HAVING ANY ALLERGIES TO MEDICATION. BEFORE SURGERY, A FORMAL WORKUP WAS PERFORMED THAT INCLUDED IMAGING STUDIES CONSISTING OF A PANORAMIC RADIOGRAPH AND CONE BEAM COMPUTED TOMOGRAPHY (CBCT) WITH 3-DIMENSIONAL INTERACTIVE COMPUTER SOFTWARE TO EVALUATE THE ANTERIOR MANDIBLE FOR IMPLANT PLACEMENT IN THE INTERFORAMINAL REGION. BASED ON THE IMAGING STUDIES, THERE WAS SATISFACTORY BONE VOLUME IN ALL 3 DIMENSIONS FOR IMPLANT PLACEMENT IN THE ANTERIOR MANDIBLE. A TREATMENT PLAN WAS FORMULATED WHERE FOUR 3.5 MM 3 15.0 MM IMPLANTS WOULD BE IMMEDIATELY PLACED IN THE INTERFORAMINAL REGION TO SUPPORT A COMPLETE MANDIBULAR OVERDENTURE AFTER THE TEETH WERE EXTRACTED, AND AN ALVEOLECTOMY WAS PERFORMED. USE OF LONG IMPLANTS AND BICORTICAL STABILIZATION ARE ACCEPTED STANDARDS OF CARE TO ACHIEVE PRIMARY IMPLANT STABILITY TO OBTAIN OSSEOINTEGRATION AND SUPPORT OVERDENTURES IN THE ANTERIOR MANDIBLE. SURGERY WAS PERFORMED UNDER LOCAL ANESTHESIA VIA BILATERAL MANDIBULAR NERVE BLOCKS AND SOFT TISSUE INFILTRATION INTO THE BUCCAL AND ANTERIOR LABIAL VESTIBULE OF THE MANDIBLE. AFTER A STANDARD MUCOPERIOSTEAL INCISION WAS MADE, THE SOFT TISSUE FLAP WAS DEVELOPED AND REFLECTED OFF OF THE MANDIBLE. THE TEETH WERE EXTRACTED (NUMBERS 22, 23, AND 27), AND AN ALVEOLOPLASTY PROCEDURE WAS PERFORMED TO REMOVE THE SHARP BONE SPICULES AND UNDERCUTS WITHOUT EVENT. PREPARATION AND DRILLING OF THE 4 IMPLANT OSTEOTOMY SITES (22, 24, 25, AND 27 AREAS) WERE FOLLOWED ACCORDING TO THE INSTRUCTIONS OF THE IMPLANT MANUFACTURER. WHILE PREPARING THE 4 IMPLANT OSTEOTOMY SITES USING TWIST DRILLS OF VARYING DIAMETER, A BRISK, PULSATILE BLEED WAS ENCOUNTERED FROM THE IMPLANT OSTEOTOMY SITE IN THE LEFT CANINE REGION. THE SOURCE OF THE BLEEDING WAS IMMEDIATELY IDENTIFIED AS COMING FROM WITHIN THE OSTEOTOMY SITE AND NOT THE FLOOR OF THE MANDIBULAR INCISIVE CANAL THAT COULD RESULT IN IATROGENIC BLEEDING. INITIAL HEMOSTATIC MEASURES WERE APPLIED TO THE OSTEOTOMY SITE, SUCH AS GAUZE DIGITAL PRESSURE TO TAMPONADE THE HEMORRHAGE, WHICH WAS PROVED UNSUCCESSFUL. USE OF VARIOUS HEMO- STATIC AGENTS, SUCH AS ABSORBABLE GELATIN SPONGES (GEL FOAM; PHARMACIA AND UPJOHN, CO, KALAMAZOO, MI), MICROFIBRILLAR COLLAGEN (AVITENE; CR BARD, INC, MURRAY HILL, NJ), AND OXIDIZED CELLULOSE, (SURGICEL; ETHICON, INC, SOMER- VILLE, NJ), APPLIED TO THE BLEEDING OSTEOTOMY SITE FAILED TO STOP THE BLEEDING. THE BLEEDING WAS VERY BRISK, AS ATTEMPTS TO PLACE THE HEMOSTATIC AGENTS INTO THE OSTEOTOMY SITE WERE UNSUCCESSFUL, AS THEY WOULD IMMEDIATELY FLOW BACK UP AND OUT OF THE OSTEOTOMY SITE. AS A FINAL MEASURE TO STOP THE BLEEDING, TOPICAL BOVINE THROMBIN (THROMBINE-JMI, PFIZER, NEW YORK, NY) WAS APPLIED TO ARREST THE HEMORRHAGING BUT TO NO AVAIL. AS ALL LOCAL HEMOSTATIC MANEUVERS FAILED TO CONTROL THE BRISK, PULSATILE BLEEDING FROM THE IMPLANT SITE, AN IMPLANT WAS PLACED INTO THE OSTEOTOMY SITE, SIMILAR TO CAPPING OFF A SPOUTING OIL WELL. WITH THE IMPLANT PLACED INTO THE OSTEOTOMY SITE, THE BRISK, PULSATILE BLEEDING WAS OBSERVED TO HAVE FINALLY SLOWED FROM THE IMPLANT SITE. HOWEVER, INSPECTION OF THE ANTERIOR MANDIBLE REVEALED THAT THE BLEEDING HAD NOT BEEN TOTALLY ARRESTED BECAUSE SLOW BLEEDING WAS NOW OBSERVED FROM THE OTHER IMPLANT OSTEOTOMY SITES (23 AND 24 AREAS). DURING THE ENTIRE ACUTE HEMORRHAGIC EPISODE, THE PATIENT WAS CONSTANTLY MONITORED AND DID NOT DEMONSTRATE ANY CLINICAL SIGNS OF CARDIAC INSTABILITY AND RESPIRATORY DISTRESS, SUCH AS FLOOR OF MOUTH EDEMA OR TONGUE ELEVATION THAT COULD LEAD TO RESPIRATORY OBSTRUCTION. PATENCY OF THE PATIENT'S AIRWAY WAS ALWAYS A TOP PRIORITY. AS ALL LOCAL HEMOSTATIC MEASURES FAILED TO ARREST THE BLEEDING, THE DECISION WAS MADE TO TRANSPORT THE PATIENT ACCOMPANIED BY THE SURGEON (C.Y.S.L.) TO THE EMERGENCY DEPARTMENT (ED) OF A NEARBY HOSPITAL 10 MINUTES AWAY FROM THE OFFICE FOR CONTINUED TREATMENT OF THE PROFUSE ARTERIAL BLEEDING AND TO MANAGE ANY POTENTIAL MEDICAL COMPLICATIONS, SUCH AS FLUID VOLUME RESUSCITATION AND AIRWAY OBSTRUCTION. IN ADDITION, LABORATORY VALUES COULD BE OBTAINED TO MONITOR THE PATIENT'S HEMODYNAMIC CONDITION. ON ADMISSION TO THE ED, THE PATIENT PRESENTED WITH A BLOOD PRESSURE OF 205/102 MM HG AND A PULSE RATE OF 83 BEATS/MINUTE. HE DENIED HAVING A SIGNIFICANT MEDICAL HISTORY AND DENIED TAKING ANY MEDICATIONS. THE PATIENT HAD NO KNOWN ALLERGIES TO MEDICATION AND DENIED TOBACCO USE BUT ADMITTED TO OCCASIONAL ALCOHOL USE. THE PHYSICAL EXAMINATION WAS UNREMARKABLE. THE ABDOMEN WAS SOFT AND NONDISTENDED. NO HEPATOSPLENOMEGALY WAS OBSERVED. THE CARDIOVASCULAR AND PULMONARY EXAMINATIONS WERE UNREMARKABLE. UNDER CONSTANT MONITORING IN THE ED, THE PATIENT DID NOT DEMONSTRATE ANY PROGRESSIVE SIGNS AND SYMPTOMS OF RESPIRATORY DISTRESS OR HYPOVOLEMIC COMPROMISE. HOWEVER, IF THE PATIENT DEMONSTRATED ANY EVIDENCE OF ACUTE RESPIRATORY DISTRESS, IT WAS DECIDED THAT THE PATIENT WOULD BE PROPHYLACTICALLY INTUBATED TO MAINTAIN THE AIRWAY. BASELINE LABORATORY VALUES IMMEDIATELY OBTAINED IN THE ED DEMONSTRATED A RED BLOOD CELL COUNT OF 5.01 (NORMAL RANGE, 4.7-6.1 MILLION CELLS/ML), WHITE BLOOD CELL COUNT OF 10.0 (NORMAL RANGE, 4500-10,000 CELLS/ ML), PLATELET COUNT OF 333,000/CUBIC MILLIMETER (NORMAL RANGE, 150,000- 400,000/MM3), HEMOGLOBIN LEVEL OF 15.0 G/DL (NORMAL RANGE, 13.8-17.2 G/DL), AND A HEMATOCRIT LEVEL OF 44.3% (NORMAL RANGE, 40.7%-50.3%). THE PROTHROMBIN TIME WAS 12.6 SECONDS (NORMAL RANGE, 10-12 SECONDS); PARTIAL THROMBO- PLASTIN TIME WAS 31 SECONDS (NORMAL RANGE, 30-45 SECONDS), AND INTERNATIONAL NORMALIZED RATIO VALUE WAS 0.97 (NORMAL RANGE, 1-2). IN CONSULTATION WITH THE ED PHYSICIANS, USE OF WHOLE BLOOD, FRESH FROZEN PLASMA, PACKED RED BLOOD CELLS, AND PLATELETS WOULD ALL BE CONSIDERED TO MAINTAIN THE PATIENT'S HEMOSTATIC VOLUME. AS LIGATION OF THE BLEEDING VESSEL IS THE PREFERRED TREATMENT TO TERMINATE BLEEDING, THIS IS OFTEN TIMES IMPOSSIBLE DUE TO THE LOCATION OF THE VESSEL AND SURGICAL ACCESS. SURGICAL MEASURES CONSIDERED TO OBTAIN DEFINITIVE CONTROL OF THE BLEEDING VESSEL INCLUDED EXPLORATORY SURGERY WITH SELECTIVE LIGATION OF THE BRANCHES OF THE EXTERNAL CAROTID ARTERY AND ARTERIAL EMBOLIZATION VIA- INTERVENTIONAL ANGIOGRAPHY. HOWEVER, AS THE AUTHORS WERE FAMILIAR WITH THE HEMOSTATIC AGENT FLOSEAL, THE DECISION WAS MADE TO APPLY THIS BIOACTIVE HEMOSTATIC AGENT TO THE OSTEOTOMY SITE IN THE ED BEFORE CONSIDERING TRANSFUSION OF BLOOD PRODUCTS AND SURGICAL INTERVENTION. WITH THE REMOVAL OF THE IMPLANT FROM THE OSTEOTOMY SITE, RESUMPTION OF BRISK, PULSATILE BLEEDING WAS OBSERVED. CONSTANT OOZING OF BLOOD WAS ALSO OBSERVED FROM THE OTHER OSTEOTOMY SITES WHEN THE GAUZE PACKS WERE REMOVED. DIRECT ACCESS TO THE INTRAOSSEOUS BLEEDING VESSEL WAS NOT POSSIBLE. FLOSEAL WAS PREPARED ACCORDING TO THE INSTRUCTIONS OF THE MANUFACTURER AND APPLIED TO THE IMPLANT OSTEOTOMY SITE WITH FIRM GAUZE PRESSURE. THROMBIN, 2500 INTERNATIONAL UNITS, WAS RECONSTITUTED IN STERILE SALINE AND MIXED WITH THE COLLAGEN MATRIX. WITHIN 10 MINUTES AFTER THE APPLICATION OF FLOSEAL GEL TO THE OSTEOTOMY SITE WITH FIRM DIGITAL PRESSURE, BLEEDING MARKEDLY SLOWED. THE ACTIVE HEMOSTATIC AGENT WAS THEN APPLIED TO THE OTHER OSTEOTOMY SITES FOLLOWED BY FIRM GAUZE PRESSURE. AFTER 1 HOUR OF CONTINUED OBSERVATION, THE PROFUSE BLEEDING WAS ONLY OOZING FROM THE IMPLANT OSTEOTOMY SITES THEN. AFTER 4 HOURS OF FURTHER OBSERVATION IN THE ED, THE PATIENT WAS DISCHARGED TO HOME IN STABLE CONDITION. THROUGHOUT THE ENTIRE COURSE, THE PATIENT'S VITAL SIGNS REMAINED STABLE. IT WAS ESTIMATED THAT PATIENT'S BLOOD LOSS WAS APPROXIMATELY 300 ML. APPROXIMATELY 1 LITER OF CRYSTALLOID WAS TRANSFUSED TO THE PATIENT. THE PATIENT RETURNED TO THE OFFICE IN 1 WEEK FOR OBSERVATION OF THE SURGICAL SITE. HE REPORTED ONLY SPORADIC OOZING OF BLOOD FROM THE OSTEOTOMY SITES WHILE RECOVERING OVER THE NEXT 24 HOURS AT HOME. POSTOPERATIVE EDEMA AND ECCHYMOSIS PROVED TO BE THE MAIN CONCERN TO THE PATIENT RATHER THAN THE BLEEDING EPISODE. POSTOPERATIVE IMAGING STUDIES CONSISTING OF CBCT SCANS OF THE MANDIBLE WERE OBTAINED TO EVALUATE THE POSSIBLE CAUSE OF THE INTRAOPERATIVE BLEEDING. USING 3-DIMENSIONAL INTERACTIVE COMPUTER SOFTWARE (SIMPLANT, GLEN BURNIE, MD), DENTAL IMPLANT SURGERY USING TWIST DRILLS WAS SIMULATED AND IMPLANTS OF 15.0 MM IN LENGTH COULD VIOLATE THE NEUROVASCULAR STRUCTURES IN THE ANTERIOR MANDIBULAR INCISIVE CANAL. IT CAN BE OBSERVED THAT VIRTUAL IMPLANT PLACEMENT OF ALL 4 IMPLANTS WOULD ENCOUNTER THE NEUROVASCULAR BUNDLE OF THE MANDIBULAR INCISIVE CANAL THAT COULD LEAD TO IATROGENIC PROFUSE BLEEDING. DENTAL IMPLANT SURGERY IN THE ANTERIOR MANDIBLE IS A COMMON SURGICAL PROCEDURE THAT IS CONSIDERED RELATIVELY SAFE AND FREE OF COMPLICATIONS. WE BELIEVE THAT LACERATION OF THE VASCULAR STRUCTURES IN THE MANDIBULAR INCISIVE CANAL DURING THE IMPLANT OSTEOTOMY PROCEDURE WHILE USING A LONG TWIST DRILL WAS THE CAUSE FOR THE ACUTE PROFUSE HEMORRHAGE ENCOUNTERED INTRAOPERATIVELY. THIS CASE REPORT IS UNIQUE BECAUSE THE TREATMENT PLAN WAS TO PLACE 4 IMPLANTS OF 15.0 MM IN LENGTH INTO THE ANTERIOR MANDIBLE TO ACHIEVE PRIMARY IMPLANT STABILITY. TREATMENT USING LONG DENTAL IMPLANTS IN THE ANTERIOR MANDIBLE TO STABILIZE A MANDIBULAR OVERDENTURE IS CONSIDERED A SAFE AND ACCEPTABLE PROCEDURE, AS WELL AS OBTAINING BICORTICAL STABILIZATION. KNOWLEDGE OF SURGICAL ANATOMY IS CRITICAL, AS DIFFERENT IN-OFFICE SURGICAL PROCEDURES ARE ROUTINELY PERFORMED IN THE ANTERIOR MANDIBLE, SUCH AS DENTAL IMPLANT SURGERY, EXTRACTION OF TEETH, HARVESTING BONE FROM THE SYMPHYSIS OF THE CHIN, TORI REMOVAL, AND TRAUMA SURGERY TO REPAIR FRACTURES OF THE MANDIBLE. ALL OF THESE SURGICAL PROCEDURES MAY ACCIDENTLY RESULT IN SEVERE BLEEDING FROM THE MANDIBULAR INCISIVE CANAL. IF NOT EMERGENTLY MANAGED, THIS COMPLICATION MAY ESCALATE TO A SITUATION OF SIGNIFICANT BLOOD LOSS, OR PROGRESS TO A LIFE-THREATENING DISSECTING HEMATOMA IN THE FLOOR OF THE MOUTH THAT COULD LEAD TO RESPIRATORY OBSTRUCTION. THE CLINICIAN PERFORMING SURGERY IN THIS ANA- TOMICAL REGION MUST BE PREPARED TO MANAGE SUCH COMPLICATIONS. SEVERAL AUTHORS HAVE INVESTIGATED THE VASCULAR ANATOMY OF THE ANTERIOR MANDIBLE AND HEAD AND NECK REGION BY CADAVER DISSECTION, COMPUTED TOMOGRAPHY, AND ULTRASOUND. IN 1928, OLIVIER13 FIRST DESCRIBED THE MANDIBULAR INCISIVE NERVE AS A CONTINUATION OF THE INFERIOR ALVEOLAR NERVE FROM THE POSTERIOR MANDIBLE. OTHER AUTHORS HAVE DEFINED THE NEUROANATOMICAL STRUCTURES IN THIS LOCATION BY DIVIDING THE INFERIOR ALVEOLAR NERVE INTO BRANCHES OF THE MENTAL AND MANDIBULAR INCISIVE NERVE. THEY FURTHER DESCRIBED THE SUBLINGUAL AND SUBMENTAL ARTERIES AS ANASTOMOSING BRANCHES FROM THE EXTERNAL CAROTID ARTERY THAT ENTER THE MIDLINE OF THE ANTERIOR MANDIBLE VIA THE LINGUAL FORAMEN. STUDIES BY VANDEWALLE ET AL18 AND LIANG ET AL19 DESCRIBED THE NEUROVASCU- LAR ANATOMY OF THE ANTERIOR MANDIBLE AND FLOOR OF THE MOUTH. BOTH AUTHORS WERE IN AGREEMENT OF THE POTENTIAL INTRA- OPERATIVE RISK OF NEUROVASCULAR INJURY WHILE PLACING DENTAL IMPLANTS IN THE ANTERIOR MANDIBLE DUE TO THE CLOSE PROX- IMITY OF THESE ANATOMICAL STRUCTURES. IN A CADAVER STUDY BY ROSANO ET AL, THEY EVALUATED 60 DRY MANDIBLES AND RECOMMENDED AGAINST THE USE OF SURGICALLY PLACING LONG IMPLANTS TO AVOID THE RISK OF SURGICAL TRAUMA TO THE LINGUAL CORTICAL PLATE THAT COULD LEAD TO SEVERE BLEEDING IN THE FLOOR OF THE MOUTH. MAKRIS ET AL, 21 USING CBCT SCANS OBTAINED FROM 100 PATIENTS, EVALUATED THE VISIBILITY OF THE INCISIVE CANAL AND LINGUAL FORAMEN. THE INCISIVE CANAL WAS VISIBLE IN 83.5% OF THE SCANS. THE MEAN END POINT WAS APPROXIMATELY 15 MM ANTERIOR TO THE MENTAL FORAMEN. THE MEAN DISTANCE FROM THE INFERIOR BORDER OF THE MANDIBLE WAS 11.5 MM. THE LINGUAL FORAMEN WAS VISIBLE IN 81% OF THE SCANS. THE RESULTS OF THIS STUDY DEMONSTRATE THE POTENTIAL RISK OF IATROGENIC INJURY TO THE VASCULAR STRUCTURES IN THE ANTERIOR MANDIBLE DURING IMPLANT PREPARATION THAT COULD LEAD TO HEMORRHAGIC EPISODES. PROFUSE, PULSATILE, AND BRISK BLEEDING FROM DENTAL IMPLANT SURGERY IN THE ANTERIOR MANDIBLE IS UNCOMMON. ALTHOUGH OUR CASE DID NOT PROGRESS TO A LIFE-THREATENING SITUATION, INTRAOPERATIVE BLEEDING CAN BECOME SUBSTANTIAL AND PROGRESS TO A LIFE-THREATENING SITUATION. IT HAS BEEN ESTIMATED THAT 400 ML OF BLOOD COULD BE DRAINED FROM A BLOOD VESSEL WITH AN INTRAVASCULAR DIAMETER OF 1 TO 2 MM IN 30 MINUTES. BLEEDING THAT IS DIFFICULT TO CONTROL OR INEFFECTIVE IS ALWAYS A CHALLENGE TO THE SURGEON. THE SURGEON MUST REMAIN COMPOSED AND CALM TO ARREST THE BLEEDING. PROMPT RECOGNITION AND MANAGEMENT OF THE SOURCE OF BLEEDING WITH ANY SURGICAL PROCEDURE IS CRITICAL TO AVOID PROGRESSION TO SEVERE LIFE-THREATENING COMPLICATIONS. HEMOSTATIC STRATEGIES: KNOWLEDGE IN THE MECHANISM OF HEMOSTASIS IS CRITICAL IN THE OVERALL OUT- COME OF THE SURGICAL PATIENT. HEMOSTASIS CONSISTS OF A SERIES OF COORDINATED, COMPLEX REACTIONS IN THE COAGULATION CASCADE THAT INVOLVES THE PLATELETS AND BLOOD VESSEL WALL. WHEN INTRAOPERATIVE BLEEDING IS ENCOUNTERED, THE SURGEON HAS SEVERAL OPTIONS TO TERMINATE THE BLEEDING. THESE INCLUDE MECHANICAL AND THERMAL METHODS, TO THE USE OF PHARMACOLOGIC AND TOPICAL AGENTS. ATTEMPTS TO CONTROL INTRAOPERATIVE BLEEDING ARE DEPENDENT ON MANY VARIABLES, BUT INITIALLY, THEY RELY ON DIRECT PRESSURE OR COMPRESSION WITH GAUZE PACKING AT THE BLEEDING SITE. MECHANICAL METHODS CONSIST OF THE USE OF SUTURES TO LIGATE THE SOURCE OF BLEEDING, STAPLES, AND LIGATING CLIPS. 26 HOWEVER, THESE TECHNIQUES CAN BE APPLIED IF THE SOURCE OF BLEEDING IS IDENTIFIED AND VISUALIZED. THERMAL TECHNIQUES USING LASERS AND ELECTROCAUTERY ARE OPTIONS AVAILABLE TO THE SURGEON BUT MAY BE UNAVAILABLE IN THE OFFICE SETTING. MECHANICAL AND THERMAL TECHNIQUES MAY NOT ALWAYS BE ABLE TO EFFECTIVELY CONTROL THE SOURCE OF BLEEDING, SUCH AS IN BONY STRUCTURES, INFLAMED SOFT TISSUES, AND DIFFUSE BLEEDING CAPILLARIES. IN THESE INSTANCES, THE USE OF PHARMACOLOGIC AGENTS MIGHT BE MORE APPROPRIATE. THESE AGENTS ARE USED TO ENHANCE THE COAGULATION CASCADE OF THE PATIENT AND INCLUDE INJECTION OF LOCAL ANESTHETIC THAT CONTAINS EPINEPHRINE, TISSUE ADHESIVES, AND TOPICAL HEMOSTATS. IN THE OFFICE SETTING, THE SURGEON SHOULD HAVE SEVERAL DIFFERENT TYPES OF HEMOSTATIC PRODUCTS AVAILABLE TO CONTROL AND ARREST BLEEDING. TOPICAL HEMOSTATS ARE DIVIDED INTO 2 CATEGORIES: PASSIVE AND ACTIVE. PASSIVE ABSORBABLE HEMOSTATS ARE USED TO APPLY DIRECT PRESSURE TO TAMPONADE THE HEMORRHAGE AND INCLUDE COLLAGEN SPONGES, GELATINS, AND CELLULOSE. BIOLOGICALLY ACTIVE TOPICAL HEMOSTATS ARE THROMBIN AND COMBINATION PRODUCTS THAT CONTAIN THROMBIN, SUCH AS FLOSEAL. IN OUR CASE, ATTEMPTS TO CONTROL THE PROFUSE, BRISK, PULSATILE BLEEDING IN THE OFFICE WITH VARIOUS TOPICAL HEMOSTATIC MEASURES PROVED UNSUCCESSFUL. LIGATION OF A BLEEDING VESSEL IS THE TREATMENT OF CHOICE, BUT IT IS OFTEN DIFFICULT OR IMPOSSIBLE DUE TO SURGICAL ACCESS AND ANATOMY. THIS PROVED TO BE THE SITUATION IN OUR PATIENT. THEREFORE, ONCE IN THE ED, THE DECISION WAS MADE TO USE AN ACTIVE BIOACTIVE HEMOSTAT, SUCH AS FLOSEAL. ALTHOUGH FLOSEAL IS NOT AVAIL- ABLE FOR IN-OFFICE USE, CLINICIANS WHO PERFORM SURGERY SHOULD BE AWARE OF THIS HEMOSTATIC PRODUCT TO CONTROL BLEEDING THAT RANGES FROM OOZING TO ARTERIAL SPURTING. THIS UNIQUE CHARACTERISTIC OF TISSUE EXPANSION IN THE AREA OF BLEEDING IS THE PRIMARY MECHANISM FOR TERMINATING THE SOURCE OF BLEEDING. DURING THIS PROCESS, THROMBIN ACTS ON THE PATIENT'S COAGULATION CASCADE BY CONVERTING FIBRINOGEN TO FIBRIN. THIS ACTIVITY PERMITS THE FIBRIN CLOT TO INTEGRATE WITH THE FLOSEAL MATRIX PARTICLES THAT WILL FORM A FLOSEAL-FIBRIN MATRIX CLOT THAT HAS A TAMPONADING EFFECT ON THE BLEEDING VESSEL WALL. IN OUR CASE, FLOSEAL WAS ABLE TO SIGNIFICANTLY REDUCE AND TERMINATE THE BLEEDING WHEN ALL OTHER TOPICAL HEMOSTATIC MEASURES FAILED DUE TO ITS BIOLOGIC AND MECHANICAL PROPERTIES. WE RECOMMEND THAT FLOSEAL SHOULD BE CONSIDERED IN CASES WHERE INTRA- OPERATIVE AND POSTOPERATIVE BLEEDING BECOMES PROBLEMATIC. HOWEVER, THE SURGEON MUST BE AWARE OF THE LIMITATIONS OF ALL TOPICAL HEMOSTATIC AGENTS. LIKE OTHER TOPICAL HEMOSTATIC AGENTS, FLOSEAL WILL PROBABLY NOT STOP HIGH- PRESSURE TYPES OF BLEEDING. IN THESE INSTANCES, OTHER CONVENTIONAL SURGICAL MEANS SHOULD BE CONSIDERED. THIS CASE REPORT DETAILS AN UNEXPECTED, IN-OFFICE, INTRAOPERATIVE VASCULAR COMPLICATION IN THE ANTERIOR MANDIBLE DURING IMPLANT SURGERY THAT IS CONSIDERED APPROPRIATE AND THE STANDARD OF CARE. PREVIOUS REPORTS DEMONSTRATING LIFE-THREATENING HEMORRHAGE AND HEMATOMA FORMATION IN THE FLOOR OF THE MOUTH LEADING TO RESPIRATORY OBSTRUCTION HAVE BEEN REPORTED. IN MANY OF THESE CASES, A DRILLING DEPTH OF 15 MM DURING IMPLANT OSTEOTOMY PREPARATION WAS THE CAUSE OF ARTERIAL INJURY THROUGH MISANGULATION OF THE BUR THROUGH THE LINGUAL CORTICAL PLATE. THEREFORE, THE LENGTH OF IMPLANTS TO BE PLACED IN THE ANTERIOR MANDIBLE SHOULD BE CAREFULLY CONSIDERED. SEVERAL AUTHORS ARE OF THE OPINION THAT BICORTICAL STABILIZATION IN THE ANTERIOR MANDIBLE IS NO LONGER NECESSARY FOR IMPLANT SUCCESS, AND THE BENEFITS VERSUS THE RISKS OF PLACING IMPLANTS LONGER THAN 13 MM SHOULD BE CAREFULLY CONSIDERED. WE ARE IN AGREEMENT WITH THE AUTHORS, AS OUR CASE REPORT DEMONSTRATES THAT ATTEMPTING TO PLACE LONG IMPLANTS IN THE ANTERIOR MANDIBLE MAY VIOLATE THE NEUROVASCULAR CONTENTS WITHIN THE MANDIBULAR INCISIVE CANAL THAT COULD ALSO LEAD TO ARTERIAL BLEEDING. AMENDMENT: THE FOLLOW-UP IS TO UPDATE COMPANY CASE COMMENT. NO FOLLOW UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (03JAN2020 & 03JAN2020): THIS FOLLOW-UP REPORT RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: REASONABLY SUGGEST DEVICE MALFUNCTION WAS YES. SEVERITY OF HARM WAS S4. FAILURE MODE: UNKNOWN. IDC - LEVEL 1: QUALITY. IDC - LEVEL 2: PRODUCT COMPLAINT. IDC - LEVEL 3: COMPLAINT - FUNCTION / THERAPEUTIC PROPERTIES. QA REVIEW & RATIONALE: THE HAZARD ANALYSIS WITHIN THE RISK MANAGEMENT FILE HAS BEEN REVIEWED USING THE COMPLIANT NARRATIVE AND ASSOCIATED DOCUMENTATION FOR HAZARDS/HAZARDOUS SITUATIONS, AND THEIR ASSOCIATED SEVERITIES. THE REVIEW DETERMINED THAT THE HAZARD/HAZARDOUS SITUATION AND SEVERITY WAS S4; THEREFORE, THE COMPLAINT IS INDICATIVE OF A POTENTIALLY REPORTABLE DEVICE COMPLAINT. ADDITIONALLY, DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE MEDICAL DEVICE COMBINATION PRODUCT (MDCP) TEAM FOR EVALUATION. THE COMPLAINT, ITS PRIORITY, AND ITS CLASSIFICATION HAVE BEEN REVIEWED AND DETERMINED TO BE APPROPRIATE. NO IMMEDIATE CONTAINMENT ACTION IS REQUIRED. AN INVESTIGATION WILL BE PERFORMED. SAMPLE STATUS WAS SAMPLE AVAILABILITY UNKNOWN. A COMPLAINT HAS BEEN RECEIVED BY PFIZER (SIT NAME) WITH AN INDICATION THAT THE DEVICE HAS, OR MAY HAVE, CAUSED SERIOUS INJURY, AND FOR WHICH MDR HAS BEEN PREVIOUSLY ISSUED WITH A SEVERITY OF S4 (DETERMINATIONS MADE 03DEC2020). IMPACT TO THE DEVICE: POSSIBLE ADVERSE EVENT. MALFUNCTION IS PRESENT IN THIS CASE. HAZARDOUS SITUATION WAS DIMINISHED/ALTERED PRODUCT FUNCTION. HAZARD NUMBER (WORST CASE) WAS H10-07. SEVERITY (WORST CASE) WAS S4. A REVIEW OF PREVIOUS MDR FOUND SIMILAR CASES REGARDING LACK OF EFFECT. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED BRISK BLEEDING WAS CONSIDERED AS DUE TO DENTAL IMPLANTS, AND UNLIKELY CAUSALLY RELATED TO ITS TREATMENT/INTERVENTION WITH HEMOSTATS INCLUDING GELATIN AND THROMBIN. COMPANY CAUSALITY IS PROCESSED AS RELATED AS A CAUSAL RELATIONSHIP BETWEEN THE USE OF GELATIN AND THE LACK OF PRODUCT EFFECT CANNOT BE RULED OUT. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE REPORTED BRISK BLEEDING WAS CONSIDERED AS DUE TO DENTAL IMPLANTS, AND UNLIKELY CAUSALLY RELATED TO ITS TREATMENT/INTERVENTION WITH HEMOSTATS INCLUDING GELATIN AND THROMBIN. COMPANY CAUSALITY IS PROCESSED AS RELATED AS A CAUSAL RELATIONSHIP BETWEEN THE USE OF GELATIN AND THE LACK OF PRODUCT EFFECT CANNOT BE RULED OUT.
EVENT VERBATIM [PREFERRED TERM] AS A FINAL MEASURE TO STOP THE BLEEDING, TOPICAL BOVINE THROMBIN (THROMBINE-JMI, PFIZER,CITY NAME) WAS APPLIED TO ARREST THE HEMORRHAGING, BUT TO NO AVAILABLE [DRUG INEFFECTIVE]. CASE NARRATIVE:THIS LITERATURE REPORT IS BASED ON THE JOURNAL OF IMPLANT DENTISTRY, 2012, VOL. 21(5): PGS. 368-373, ENTITLED [BRISK, PULSATILE BLEEDING FROM THE ANTERIOR MANDIBULAR INCISIVE CANAL DURING IMPLANT SURGERY: A CASE REPORT AND USE OF AN ACTIVE HEMOSTATIC MATRIX TO TERMINATE ACUTE BLEEDING.] A 69-YEAR-OLD MAN WAS TREATMENT PLANNED FOR THE EXTRACTION OF THE 3 REMAINING MANDIBULAR ANTERIOR TEETH FOLLOWED BY IMMEDIATE IMPLANT PLACEMENT OF 4 DENTAL IMPLANTS TO SUPPORT A COMPLETE OVERDENTURE AND BAR. THE PATIENT'S MEDICAL HISTORY WAS UNREMARKABLE AND NEGATIVE FOR COAGULOPATHIES. HE WAS NOT PRESCRIBED ANY MEDICATIONS AND DENIED HAVING ANY ALLERGIES TO MEDICATION. BEFORE SURGERY, A FORMAL WORKUP WAS PERFORMED THAT INCLUDED IMAGING STUDIES CONSISTING OF A PANORAMIC RADIOGRAPH AND CONE BEAM COMPUTED TOMOGRAPHY (CBCT) WITH 3-DIMENSIONAL INTERACTIVE COMPUTER SOFTWARE TO EVALUATE THE ANTERIOR MANDIBLE FOR IMPLANT PLACEMENT IN THE INTERFORAMINAL REGION. BASED ON THE IMAGING STUDIES, THERE WAS SATISFACTORY BONE VOLUME IN ALL 3 DIMENSIONS FOR IMPLANT PLACEMENT IN THE ANTERIOR MANDIBLE. A TREATMENT PLAN WAS FORMULATED WHERE FOUR 3.5 MM 3 15.0 MM IMPLANTS WOULD BE IMMEDIATELY PLACED IN THE INTERFORAMINAL REGION TO SUPPORT A COMPLETE MANDIBULAR OVERDENTURE AFTER THE TEETH WERE EXTRACTED, AND AN ALVEOLECTOMY WAS PERFORMED. USE OF LONG IMPLANTS AND BICORTICAL STABILIZATION ARE ACCEPTED STANDARDS OF CARE TO ACHIEVE PRIMARY IMPLANT STABILITY TO OBTAIN OSSEOINTEGRATION AND SUPPORT OVERDENTURES IN THE ANTERIOR MANDIBLE. SURGERY WAS PERFORMED UNDER LOCAL ANESTHESIA VIA BILATERAL MANDIBULAR NERVE BLOCKS AND SOFT TISSUE INFILTRATION INTO THE BUCCAL AND ANTERIOR LABIAL VESTIBULE OF THE MANDIBLE. AFTER A STANDARD MUCOPERIOSTEAL INCISION WAS MADE, THE SOFT TISSUE FLAP WAS DEVELOPED AND REFLECTED OFF OF THE MANDIBLE. THE TEETH WERE EXTRACTED (NUMBERS 22, 23, AND 27), AND AN ALVEOLOPLASTY PROCEDURE WAS PERFORMED TO REMOVE THE SHARP BONE SPICULES AND UNDERCUTS WITHOUT EVENT. PREPARATION AND DRILLING OF THE 4 IMPLANT OSTEOTOMY SITES (22, 24, 25, AND 27 AREAS) WERE FOLLOWED ACCORDING TO THE INSTRUCTIONS OF THE IMPLANT MANUFACTURER. WHILE PREPARING THE 4 IMPLANT OSTEOTOMY SITES USING TWIST DRILLS OF VARYING DIAMETER, A BRISK, PULSATILE BLEED WAS ENCOUNTERED FROM THE IMPLANT OSTEOTOMY SITE IN THE LEFT CANINE REGION. THE SOURCE OF THE BLEEDING WAS IMMEDIATELY IDENTIFIED AS COMING FROM WITHIN THE OSTEOTOMY SITE AND NOT THE FLOOR OF THE MANDIBULAR INCISIVE CANAL THAT COULD RESULT IN IATROGENIC BLEEDING. INITIAL HEMOSTATIC MEASURES WERE APPLIED TO THE OSTEOTOMY SITE, SUCH AS GAUZE DIGITAL PRESSURE TO TAMPONADE THE HEMORRHAGE, WHICH WAS PROVED UNSUCCESSFUL. USE OF VARIOUS HEMO- STATIC AGENTS, SUCH AS ABSORBABLE GELATIN SPONGES (GEL FOAM; PHARMACIA AND UPJOHN, CO, KALAMAZOO, MI), MICROFIBRILLAR COLLAGEN (AVITENE; CR BARD, INC, MURRAY HILL, NJ), AND OXIDIZED CELLULOSE, (SURGICEL; ETHICON, INC, SOMER- VILLE, NJ), APPLIED TO THE BLEEDING OSTEOTOMY SITE FAILED TO STOP THE BLEEDING. THE BLEEDING WAS VERY BRISK, AS ATTEMPTS TO PLACE THE HEMOSTATIC AGENTS INTO THE OSTEOTOMY SITE WERE UNSUCCESSFUL, AS THEY WOULD IMMEDIATELY FLOW BACK UP AND OUT OF THE OSTEOTOMY SITE. AS A FINAL MEASURE TO STOP THE BLEEDING, TOPICAL BOVINE THROMBIN (THROMBINE-JMI, PFIZER, NEW YORK, NY) WAS APPLIED TO ARREST THE HEMORRHAGING BUT TO NO AVAIL. AS ALL LOCAL HEMOSTATIC MANEUVERS FAILED TO CONTROL THE BRISK, PULSATILE BLEEDING FROM THE IMPLANT SITE, AN IMPLANT WAS PLACED INTO THE OSTEOTOMY SITE, SIMILAR TO CAPPING OFF A SPOUTING OIL WELL. WITH THE IMPLANT PLACED INTO THE OSTEOTOMY SITE, THE BRISK, PULSATILE BLEEDING WAS OBSERVED TO HAVE FINALLY SLOWED FROM THE IMPLANT SITE. HOWEVER, INSPECTION OF THE ANTERIOR MANDIBLE REVEALED THAT THE BLEEDING HAD NOT BEEN TOTALLY ARRESTED BECAUSE SLOW BLEEDING WAS NOW OBSERVED FROM THE OTHER IMPLANT OSTEOTOMY SITES (23 AND 24 AREAS). DURING THE ENTIRE ACUTE HEMORRHAGIC EPISODE, THE PATIENT WAS CONSTANTLY MONITORED AND DID NOT DEMONSTRATE ANY CLINICAL SIGNS OF CARDIAC INSTABILITY AND RESPIRATORY DISTRESS, SUCH AS FLOOR OF MOUTH EDEMA OR TONGUE ELEVATION THAT COULD LEAD TO RESPIRATORY OBSTRUCTION. PATENCY OF THE PATIENT'S AIRWAY WAS ALWAYS A TOP PRIORITY. AS ALL LOCAL HEMOSTATIC MEASURES FAILED TO ARREST THE BLEEDING, THE DECISION WAS MADE TO TRANSPORT THE PATIENT ACCOMPANIED BY THE SURGEON (C.Y.S.L.) TO THE EMERGENCY DEPARTMENT (ED) OF A NEARBY HOSPITAL 10 MINUTES AWAY FROM THE OFFICE FOR CONTINUED TREATMENT OF THE PROFUSE ARTERIAL BLEEDING AND TO MANAGE ANY POTENTIAL MEDICAL COMPLICATIONS, SUCH AS FLUID VOLUME RESUSCITATION AND AIRWAY OBSTRUCTION. IN ADDITION, LABORATORY VALUES COULD BE OBTAINED TO MONITOR THE PATIENT'S HEMODYNAMIC CONDITION. ON ADMISSION TO THE ED, THE PATIENT PRESENTED WITH A BLOOD PRESSURE OF 205/102 MM HG AND A PULSE RATE OF 83 BEATS/MINUTE. HE DENIED HAVING A SIGNIFICANT MEDICAL HISTORY AND DENIED TAKING ANY MEDICATIONS. THE PATIENT HAD NO KNOWN ALLERGIES TO MEDICATION AND DENIED TOBACCO USE BUT ADMITTED TO OCCASIONAL ALCOHOL USE. THE PHYSICAL EXAMINATION WAS UNREMARKABLE. THE ABDOMEN WAS SOFT AND NONDISTENDED. NO HEPATOSPLENOMEGALY WAS OBSERVED. THE CARDIOVASCULAR AND PULMONARY EXAMINATIONS WERE UNREMARKABLE. UNDER CONSTANT MONITORING IN THE ED, THE PATIENT DID NOT DEMONSTRATE ANY PROGRESSIVE SIGNS AND SYMPTOMS OF RESPIRATORY DISTRESS OR HYPOVOLEMIC COMPROMISE. HOWEVER, IF THE PATIENT DEMONSTRATED ANY EVIDENCE OF ACUTE RESPIRATORY DISTRESS, IT WAS DECIDED THAT THE PATIENT WOULD BE PROPHYLACTICALLY INTUBATED TO MAINTAIN THE AIRWAY. BASELINE LABORATORY VALUES IMMEDIATELY OBTAINED IN THE ED DEMONSTRATED A RED BLOOD CELL COUNT OF 5.01 (NORMAL RANGE, 4.7-6.1 MILLION CELLS/ML), WHITE BLOOD CELL COUNT OF 10.0 (NORMAL RANGE, 4500-10,000 CELLS/ ML), PLATELET COUNT OF 333,000/CUBIC MILLIMETER (NORMAL RANGE, 150,000- 400,000/MM3), HEMOGLOBIN LEVEL OF 15.0 G/DL (NORMAL RANGE, 13.8-17.2 G/DL), AND A HEMATOCRIT LEVEL OF 44.3% (NORMAL RANGE, 40.7%-50.3%). THE PROTHROMBIN TIME WAS 12.6 SECONDS (NORMAL RANGE, 10-12 SECONDS); PARTIAL THROMBO- PLASTIN TIME WAS 31 SECONDS (NORMAL RANGE, 30-45 SECONDS), AND INTERNATIONAL NORMALIZED RATIO VALUE WAS 0.97 (NORMAL RANGE, 1-2). IN CONSULTATION WITH THE ED PHYSICIANS, USE OF WHOLE BLOOD, FRESH FROZEN PLASMA, PACKED RED BLOOD CELLS, AND PLATELETS WOULD ALL BE CONSIDERED TO MAINTAIN THE PATIENT'S HEMOSTATIC VOLUME. AS LIGATION OF THE BLEEDING VESSEL IS THE PREFERRED TREATMENT TO TERMINATE BLEEDING, THIS IS OFTEN TIMES IMPOSSIBLE DUE TO THE LOCATION OF THE VESSEL AND SURGICAL ACCESS. SURGICAL MEASURES CONSIDERED TO OBTAIN DEFINITIVE CONTROL OF THE BLEEDING VESSEL INCLUDED EXPLORATORY SURGERY WITH SELECTIVE LIGATION OF THE BRANCHES OF THE EXTERNAL CAROTID ARTERY AND ARTERIAL EMBOLIZATION VIA- INTERVENTIONAL ANGIOGRAPHY. HOWEVER, AS THE AUTHORS WERE FAMILIAR WITH THE HEMOSTATIC AGENT FLOSEAL, THE DECISION WAS MADE TO APPLY THIS BIOACTIVE HEMOSTATIC AGENT TO THE OSTEOTOMY SITE IN THE ED BEFORE CONSIDERING TRANSFUSION OF BLOOD PRODUCTS AND SURGICAL INTERVENTION. WITH THE REMOVAL OF THE IMPLANT FROM THE OSTEOTOMY SITE, RESUMPTION OF BRISK, PULSATILE BLEEDING WAS OBSERVED. CONSTANT OOZING OF BLOOD WAS ALSO OBSERVED FROM THE OTHER OSTEOTOMY SITES WHEN THE GAUZE PACKS WERE REMOVED. DIRECT ACCESS TO THE INTRAOSSEOUS BLEEDING VESSEL WAS NOT POSSIBLE. FLOSEAL WAS PREPARED ACCORDING TO THE INSTRUCTIONS OF THE MANUFACTURER AND APPLIED TO THE IMPLANT OSTEOTOMY SITE WITH FIRM GAUZE PRESSURE. THROMBIN, 2500 INTERNATIONAL UNITS, WAS RECONSTITUTED IN STERILE SALINE AND MIXED WITH THE COLLAGEN MATRIX. WITHIN 10 MINUTES AFTER THE APPLICATION OF FLOSEAL GEL TO THE OSTEOTOMY SITE WITH FIRM DIGITAL PRESSURE, BLEEDING MARKEDLY SLOWED. THE ACTIVE HEMOSTATIC AGENT WAS THEN APPLIED TO THE OTHER OSTEOTOMY SITES FOLLOWED BY FIRM GAUZE PRESSURE. AFTER 1 HOUR OF CONTINUED OBSERVATION, THE PROFUSE BLEEDING WAS ONLY OOZING FROM THE IMPLANT OSTEOTOMY SITES THEN. AFTER 4 HOURS OF FURTHER OBSERVATION IN THE ED, THE PATIENT WAS DISCHARGED TO HOME IN STABLE CONDITION. THROUGHOUT THE ENTIRE COURSE, THE PATIENT'S VITAL SIGNS REMAINED STABLE. IT WAS ESTIMATED THAT PATIENT'S BLOOD LOSS WAS APPROXIMATELY 300 ML. APPROXIMATELY 1 LITER OF CRYSTALLOID WAS TRANSFUSED TO THE PATIENT. THE PATIENT RETURNED TO THE OFFICE IN 1 WEEK FOR OBSERVATION OF THE SURGICAL SITE. HE REPORTED ONLY SPORADIC OOZING OF BLOOD FROM THE OSTEOTOMY SITES WHILE RECOVERING OVER THE NEXT 24 HOURS AT HOME. POSTOPERATIVE EDEMA AND ECCHYMOSIS PROVED TO BE THE MAIN CONCERN TO THE PATIENT RATHER THAN THE BLEEDING EPISODE. POSTOPERATIVE IMAGING STUDIES CONSISTING OF CBCT SCANS OF THE MANDIBLE WERE OBTAINED TO EVALUATE THE POSSIBLE CAUSE OF THE INTRAOPERATIVE BLEEDING. USING 3-DIMENSIONAL INTERACTIVE COMPUTER SOFTWARE (SIMPLANT, GLEN BURNIE, MD), DENTAL IMPLANT SURGERY USING TWIST DRILLS WAS SIMULATED AND IMPLANTS OF 15.0 MM IN LENGTH COULD VIOLATE THE NEUROVASCULAR STRUCTURES IN THE ANTERIOR MANDIBULAR INCISIVE CANAL. IT CAN BE OBSERVED THAT VIRTUAL IMPLANT PLACEMENT OF ALL 4 IMPLANTS WOULD ENCOUNTER THE NEUROVASCULAR BUNDLE OF THE MANDIBULAR INCISIVE CANAL THAT COULD LEAD TO IATROGENIC PROFUSE BLEEDING. DENTAL IMPLANT SURGERY IN THE ANTERIOR MANDIBLE IS A COMMON SURGICAL PROCEDURE THAT IS CONSIDERED RELATIVELY SAFE AND FREE OF COMPLICATIONS. WE BELIEVE THAT LACERATION OF THE VASCULAR STRUCTURES IN THE MANDIBULAR INCISIVE CANAL DURING THE IMPLANT OSTEOTOMY PROCEDURE WHILE USING A LONG TWIST DRILL WAS THE CAUSE FOR THE ACUTE PROFUSE HEMORRHAGE ENCOUNTERED INTRAOPERATIVELY. THIS CASE REPORT IS UNIQUE BECAUSE THE TREATMENT PLAN WAS TO PLACE 4 IMPLANTS OF 15.0 MM IN LENGTH INTO THE ANTERIOR MANDIBLE TO ACHIEVE PRIMARY IMPLANT STABILITY. TREATMENT USING LONG DENTAL IMPLANTS IN THE ANTERIOR MANDIBLE TO STABILIZE A MANDIBULAR OVERDENTURE IS CONSIDERED A SAFE AND ACCEPTABLE PROCEDURE, AS WELL AS OBTAINING BICORTICAL STABILIZATION. KNOWLEDGE OF SURGICAL ANATOMY IS CRITICAL, AS DIFFERENT IN-OFFICE SURGICAL PROCEDURES ARE ROUTINELY PERFORMED IN THE ANTERIOR MANDIBLE, SUCH AS DENTAL IMPLANT SURGERY, EXTRACTION OF TEETH, HARVESTING BONE FROM THE SYMPHYSIS OF THE CHIN, TORI REMOVAL, AND TRAUMA SURGERY TO REPAIR FRACTURES OF THE MANDIBLE. ALL OF THESE SURGICAL PROCEDURES MAY ACCIDENTLY RESULT IN SEVERE BLEEDING FROM THE MANDIBULAR INCISIVE CANAL. IF NOT EMERGENTLY MANAGED, THIS COMPLICATION MAY ESCALATE TO A SITUATION OF SIGNIFICANT BLOOD LOSS, OR PROGRESS TO A LIFE-THREATENING DISSECTING HEMATOMA IN THE FLOOR OF THE MOUTH THAT COULD LEAD TO RESPIRATORY OBSTRUCTION. THE CLINICIAN PERFORMING SURGERY IN THIS ANA- TOMICAL REGION MUST BE PREPARED TO MANAGE SUCH COMPLICATIONS. SEVERAL AUTHORS HAVE INVESTIGATED THE VASCULAR ANATOMY OF THE ANTERIOR MANDIBLE AND HEAD AND NECK REGION BY CADAVER DISSECTION, COMPUTED TOMOGRAPHY, AND ULTRASOUND. IN 1928, OLIVIER13 FIRST DESCRIBED THE MANDIBULAR INCISIVE NERVE AS A CONTINUATION OF THE INFERIOR ALVEOLAR NERVE FROM THE POSTERIOR MANDIBLE. OTHER AUTHORS HAVE DEFINED THE NEUROANATOMICAL STRUCTURES IN THIS LOCATION BY DIVIDING THE INFERIOR ALVEOLAR NERVE INTO BRANCHES OF THE MENTAL AND MANDIBULAR INCISIVE NERVE. THEY FURTHER DESCRIBED THE SUBLINGUAL AND SUBMENTAL ARTERIES AS ANASTOMOSING BRANCHES FROM THE EXTERNAL CAROTID ARTERY THAT ENTER THE MIDLINE OF THE ANTERIOR MANDIBLE VIA THE LINGUAL FORAMEN. THIS CASE REPORT DETAILS AN UNEXPECTED, IN-OFFICE, INTRAOPERATIVE VASCULAR COMPLICATION IN THE ANTERIOR MANDIBLE DURING IMPLANT SURGERY THAT IS CONSIDERED APPROPRIATE AND THE STANDARD OF CARE. PREVIOUS REPORTS DEMONSTRATING LIFE-THREATENING HEMORRHAGE AND HEMATOMA FORMATION IN THE FLOOR OF THE MOUTH LEADING TO RESPIRATORY OBSTRUCTION HAVE BEEN REPORTED. IN MANY OF THESE CASES, A DRILLING DEPTH OF 15 MM DURING IMPLANT OSTEOTOMY PREPARATION WAS THE CAUSE OF ARTERIAL INJURY THROUGH MISANGULATION OF THE BUR THROUGH THE LINGUAL CORTICAL PLATE. THEREFORE, THE LENGTH OF IMPLANTS TO BE PLACED IN THE ANTERIOR MANDIBLE SHOULD BE CAREFULLY CONSIDERED. SEVERAL AUTHORS ARE OF THE OPINION THAT BICORTICAL STABILIZATION IN THE ANTERIOR MANDIBLE IS NO LONGER NECESSARY FOR IMPLANT SUCCESS, AND THE BENEFITS VERSUS THE RISKS OF PLACING IMPLANTS LONGER THAN 13 MM SHOULD BE CAREFULLY CONSIDERED. WE ARE IN AGREEMENT WITH THE AUTHORS, AS OUR CASE REPORT DEMONSTRATES THAT ATTEMPTING TO PLACE LONG IMPLANTS IN THE ANTERIOR MANDIBLE MAY VIOLATE THE NEUROVASCULAR CONTENTS WITHIN THE MANDIBULAR INCISIVE CANAL THAT COULD ALSO LEAD TO ARTERIAL BLEEDING. AMENDMENT: THE FOLLOW-UP IS TO UPDATE COMPANY CASE COMMENT. NO FOLLOW UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (03JAN2020 & 03JAN2020): THIS FOLLOW-UP REPORT RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: REASONABLY SUGGEST DEVICE MALFUNCTION WAS YES. SEVERITY OF HARM WAS S4. FAILURE MODE: UNKNOWN. IDC - LEVEL 1: QUALITY. IDC - LEVEL 2: PRODUCT COMPLAINT. IDC - LEVEL 3: COMPLAINT - FUNCTION / THERAPEUTIC PROPERTIES. QA REVIEW & RATIONALE: THE HAZARD ANALYSIS WITHIN THE RISK MANAGEMENT FILE HAS BEEN REVIEWED USING THE COMPLIANT NARRATIVE AND ASSOCIATED DOCUMENTATION FOR HAZARDS/HAZARDOUS SITUATIONS, AND THEIR ASSOCIATED SEVERITIES. THE REVIEW DETERMINED THAT THE HAZARD/HAZARDOUS SITUATION AND SEVERITY WAS S4; THEREFORE, THE COMPLAINT IS INDICATIVE OF A POTENTIALLY REPORTABLE DEVICE COMPLAINT. ADDITIONALLY, DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE MEDICAL DEVICE COMBINATION PRODUCT (MDCP) TEAM FOR EVALUATION. THE COMPLAINT, ITS PRIORITY, AND ITS CLASSIFICATION HAVE BEEN REVIEWED AND DETERMINED TO BE APPROPRIATE. NO IMMEDIATE CONTAINMENT ACTION IS REQUIRED. AN INVESTIGATION WILL BE PERFORMED. SAMPLE STATUS WAS SAMPLE AVAILABILITY UNKNOWN. A COMPLAINT HAS BEEN RECEIVED BY PFIZER (SIT NAME) WITH AN INDICATION THAT THE DEVICE HAS, OR MAY HAVE, CAUSED SERIOUS INJURY, AND FOR WHICH MDR HAS BEEN PREVIOUSLY ISSUED WITH A SEVERITY OF S4 (DETERMINATIONS MADE (B)(6) 2020). IMPACT TO THE DEVICE: POSSIBLE ADVERSE EVENT. MALFUNCTION IS PRESENT IN THIS CASE. HAZARDOUS SITUATION WAS DIMINISHED/ALTERED PRODUCT FUNCTION. HAZARD NUMBER (WORST CASE) WAS H10-07. SEVERITY (WORST CASE) WAS S4. A REVIEW OF PREVIOUS MDR FOUND SIMILAR CASES REGARDING LACK OF EFFECT. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (05FEB2020): THIS FOLLOW-UP REPORT RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: THE HAZARD ANALYSIS WITHIN THE RISK MANAGEMENT FILE HAS BEEN REVIEWED USING THE COMPLIANT NARRATIVE AND ASSOCIATED DOCUMENTATION FOR HAZARDS/HAZARDOUS SITUATIONS, AND THEIR ASSOCIATED SEVERITIES. THE REVIEW DETERMINED THAT THE HAZARD/HAZARDOUS SITUATION AND SEVERITY WAS S4; THEREFORE, THE COMPLAINT IS INDICATIVE OF A POTENTIALLY REPORTABLE DEVICE COMPLAINT. ROOT CAUSE: PFIZER (SITE NAME) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (SITE NAME) PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (SITE NAME) SITE. IMPACT ANALYSIS: QUALITY OF LOT: ACCEPTABLE; THE WORST CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT WAS S4; THEREFORE THE DETAILS OF THE REPORTED COMPLAINT WERE FORWARDED TO PFIZER SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. ADDITIONALLY, THE DETAILS OF THE COMPLAINT HAVE BEEN FORWARDED TO THE MDCP TEAM FOR REVIEW. THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO (SITE NAME) CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. ADDITIONALLY, A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. THE COMPLAINT HAS BEEN ESCALATED TO SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN SENT TO THE MDCP TEAM FOR REVIEW. FURTHER ACTION BY PFIZER (SITE NAME) IS NOT REQUIRED. PROCESS CONTROL EVALUATION: EXISTING PROCESS CONTROLS WERE REVIEWED AS A PART OF THIS INVESTIGATION. THE REVIEW DETERMINED THAT THE PROCESS CONTROLS WERE APPROPRIATE AND ACCEPTABLE; THEREFORE THE MEDICAL DEVICE QOP WAS NOT NOTIFIED.SITE SAMPLE STATUS WAS NOT RECEIVED; (SITE NAME) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED BRISK BLEEDING WAS CONSIDERED AS DUE TO DENTAL IMPLANTS, AND UNLIKELY CAUSALLY RELATED TO ITS TREATMENT/INTERVENTION WITH HEMOSTATS INCLUDING GELATIN AND THROMBIN. COMPANY CAUSALITY IS PROCESSED AS RELATED AS A CAUSAL RELATIONSHIP BETWEEN THE USE OF GELATIN AND THE LACK OF PRODUCT EFFECT CANNOT BE RULED OUT. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE REPORTED BRISK BLEEDING WAS CONSIDERED AS DUE TO DENTAL IMPLANTS, AND UNLIKELY CAUSALLY RELATED TO ITS TREATMENT/INTERVENTION WITH HEMOSTATS INCLUDING GELATIN AND THROMBIN. COMPANY CAUSALITY IS PROCESSED AS RELATED AS A CAUSAL RELATIONSHIP BETWEEN THE USE OF GELATIN AND THE LACK OF PRODUCT EFFECT CANNOT BE RULED OUT.
EVENT VERBATIM [PREFERRED TERM] AS A FINAL MEASURE TO STOP THE BLEEDING, TOPICAL BOVINE THROMBIN (THROMBINE-JMI, PFIZER, NEW YORK, NY) WAS APPLIED TO ARREST THE HEMORRHAGING, BUT TO NO AVAIL [DRUG INEFFECTIVE] CASE NARRATIVE:THIS LITERATURE REPORT IS BASED ON THE JOURNAL OF THE IMPLANT DENTISTRY, (YEAR 2012) VOL 21(5): (PGS. 368-373) ENTITLED[BRISK, PULSATILE BLEEDING FROM THE ANTERIOR MANDIBULAR INCISIVE CANAL DURING IMPLANT SURGERY: A CASE REPORT AND USE OF AN ACTIVE HEMOSTATIC MATRIX TO TERMINATE ACUTE BLEEDING.] A 69-YEAR-OLD ASIAN MAN WAS TREATMENT PLANNED FOR THE EXTRACTION OF THE 3 REMAINING MANDIBULAR ANTERIOR TEETH FOLLOWED BY IMMEDIATE IMPLANT PLACEMENT OF 4 DENTAL IMPLANTS TO SUPPORT A COMPLETE OVERDENTURE AND BAR (FIG. 1). THE PATIENT'S MEDICAL HISTORY WAS UNREMARKABLE AND NEGATIVE FOR COAGULOPATHIES. HE WAS NOT PRESCRIBED ANY MEDICATIONS AND DENIED HAVING ANY ALLERGIES TO MEDICATION. BEFORE SURGERY, A FORMAL WORKUP WAS PERFORMED THAT INCLUDED IMAGING STUDIES CONSISTING OF A PANORAMIC RADIOGRAPH AND CONE BEAM COMPUTED TOMOGRAPHY (CBCT) WITH 3-DIMENSIONAL INTERACTIVE COMPUTER SOFTWARE TO EVALUATE THE ANTERIOR MANDIBLE FOR IMPLANT PLACEMENT IN THE INTER-FORAMINAL REGION. BASED ON THE IMAGING STUDIES, THERE WAS SATISFACTORY BONE VOLUME IN ALL 3 DIMENSIONS FOR IMPLANT PLACEMENT IN THE ANTERIOR MANDIBLE. A TREATMENT PLAN WAS FORMULATED WHERE FOUR 3.5 MM 3 15.0 MM IMPLANTS WOULD BE IMMEDIATELY PLACED IN\ THE INTERFORAMINAL REGION TO SUPPORT A COMPLETE MANDIBULAR OVERDENTURE AFTER THE TEETH WERE EXTRACTED, AND AN ALVEOLECTOMY WAS PERFORMED. USE OF LONG IMPLANTS AND BICORTICAL STABILIZATION ARE ACCEPTED STANDARDS OF CARE TO ACHIEVE PRIMARY IMPLANT STABILITY TO OBTAIN OSSEOINTEGRATION AND SUPPORT OVERDENTURES IN THE ANTERIOR MANDIBLE. SURGERY WAS PERFORMED UNDER LOCAL ANESTHESIA VIA BILATERAL MANDIBULAR NERVE BLOCKS AND SOFT TISSUE INFILTRATION INTO THE BUCCAL AND ANTERIOR LABIAL VESTIBULE OF THE MANDIBLE. AFTER A STANDARD MUCOPERIOSTEAL INCISION WAS MADE, THE SOFT TISSUE FLAP WAS DEVELOPED AND REFLECTED OFF OF THE MANDIBLE. THE TEETH WERE EXTRACTED (NUMBERS 22, 23, AND 27), AND AN ALVEOLOPLASTY PROCEDURE WAS PERFORMED TO REMOVE THE SHARP BONE SPICULES AND UNDERCUTS WITHOUT EVENT. PREPARATION AND DRILLING OF THE 4 IMPLANT OSTEOTOMY SITES (22, 24, 25, AND 27 AREAS) WERE FOLLOWED ACCORDING TO THE INSTRUCTIONS OF THE IMPLANT MANUFACTURER. WHILE PREPARING THE 4 IMPLANT OSTEOTOMY SITES USING TWIST DRILLS OF VARYING DIAMETER, A BRISK, PULSATILE BLEED WAS ENCOUNTERED FROM THE IMPLANT OSTEOTOMY SITE IN THE LEFT CANINE REGION. THE SOURCE OF THE BLEEDING WAS IMMEDIATELY IDENTIFIED AS COMING FROM WITHIN THE OSTEOTOMY SITE AND NOT THE FLOOR OF THE MANDIBULAR INCISIVE CANAL THAT COULD RESULT IN IATROGENIC BLEEDING. INITIAL HEMOSTATIC MEASURES WERE APPLIED TO THE OSTEOTOMY SITE, SUCH AS GAUZE DIGITAL PRESSURE TO TAMPONADE THE HEMORRHAGE, WHICH WAS PROVED UNSUCCESSFUL. USE OF VARIOUS HEMO- STATIC AGENTS, SUCH AS ABSORBABLE GELATIN SPONGES (GEL FOAM; PHARMACIA AND UPJOHN, CO, KALAMAZOO, MI), MICROFIBRILLAR COLLAGEN (AVITENE; CR BARD, INC, MURRAY HILL, NJ), AND OXIDIZED CELLULOSE, (SURGICEL; ETHICON, INC, SOMER- VILLE, NJ), APPLIED TO THE BLEEDING OSTEOTOMY SITE FAILED TO STOP THE BLEEDING. THE BLEEDING WAS VERY BRISK, AS ATTEMPTS TO PLACE THE HEMOSTATIC AGENTS INTO THE OSTEOTOMY SITE WERE UNSUCCESSFUL, AS THEY WOULD IMMEDIATELY FLOW BACK UP AND OUT OF THE OSTEOTOMY SITE. AS A FINAL MEASURE TO STOP THEBLEEDING, TOPICAL BOVINE THROMBIN (THROMBINE-JMI, PFIZER, NEW YORK, NY) WAS APPLIED TO ARREST THE HEMORRHAGING BUT TO NO AVAIL. AS ALL LOCAL HEMOSTATIC MANEUVERS FAILED TO CONTROL THE BRISK, PULSATILE BLEEDING FROM THE IMPLANT SITE, AN IMPLANT WAS PLACED INTO THE OSTEOTOMY SITE, SIMILAR TO CAPPING OFF A SPOUTING OIL WELL. WITH THE IMPLANT PLACED INTO THE OSTEOTOMY SITE, THE BRISK, PULSATILE BLEEDING WAS OBSERVED TO HAVE FINALLY SLOWED FROM THE IMPLANT SITE. HOWEVER, INSPECTION OF THE ANTERIOR MANDIBLE REVEALED THAT THE BLEEDING HAD NOT BEEN TOTALLY ARRESTED BECAUSE SLOW BLEEDING WAS NOW OBSERVED FROM THE OTHER IMPLANT OSTEOTOMY SITES (23 AND 24 AREAS). DURING THE ENTIRE ACUTE HEMORRHAGIC EPISODE, THE PATIENT WAS CONSTANTLY MONITORED AND DID NOT DEMONSTRATE ANY CLINICAL SIGNS OF CARDIAC INSTABILITY AND RESPIRATORY DISTRESS, SUCH AS FLOOR OF MOUTH EDEMA OR TONGUE ELEVATION THAT COULD LEAD TO RESPIRATORY OBSTRUCTION. PATENCY OF THE PATIENT'S AIRWAY WAS ALWAYS A TOP PRIORITY. AS ALL LOCAL HEMOSTATIC MEASURES FAILED TO ARREST THE BLEEDING, THE DECISION WAS MADE TO TRANSPORT THE PATIENT ACCOMPANIED BY THE SURGEON (C.Y.S.L.) TO THE EMERGENCY DEPARTMENT (ED) OF A NEARBY HOSPITAL 10 MINUTES AWAY FROM THE OFFICE FOR CONTINUED TREATMENT OF THE PROFUSE ARTERIAL BLEEDING AND TO MANAGE ANY POTENTIAL MEDICAL COMPLICATIONS, SUCH AS FLUID VOLUME RESUSCITATION AND AIRWAY OBSTRUCTION. IN ADDITION, LABORATORY VALUES COULD BE OBTAINED TO MONITOR THE PATIENT'S HEMODYNAMIC CONDITION. ON ADMISSION TO THE ED, THE PATIENT PRESENTED WITH A BLOOD PRESSURE OF 205/102 MM HG AND A PULSE RATE OF 83 BEATS/MINUTE. HE DENIED HAVING A SIGNIFICANT MEDICAL HISTORY AND DENIED TAKING ANY MEDICATIONS. THE PATIENT HAD NO KNOWN ALLERGIES TO MEDICATION AND DENIED TOBACCO USE BUT ADMITTED TO OCCASIONAL ALCOHOL USE. THE PHYSICAL EXAMINATION WAS UNREMARKABLE. THE ABDOMEN WAS SOFT AND NONDISTENDED. NO HEPATOSPLENOMEGALY WAS OBSERVED. THE CARDIOVASCULAR AND PULMONARY EXAMINATIONS WERE UNREMARKABLE. UNDER CONSTANT MONITORING IN THE ED, THE PATIENT DID NOT DEMONSTRATE ANY PROGRESSIVE SIGNS AND SYMPTOMS OF RESPIRATORY DISTRESS OR HYPOVOLEMIC COMPROMISE. HOWEVER, IF THE PATIENT DEMONSTRATED ANY EVIDENCE OF ACUTE RESPIRATORY DISTRESS, IT WAS DECIDED THAT THE PATIENT WOULD BE PROPHYLACTICALLY INTUBATED TO MAINTAIN THE AIRWAY. BASELINE LABORATORY VALUES IMMEDIATELY OBTAINED IN THE ED DEMONSTRATED A RED BLOOD CELL COUNT OF 5.01 (NORMAL RANGE, 4.7- 6.1 MILLION CELLS/ML), WHITE BLOOD CELL COUNT OF 10.0 (NORMAL RANGE, 4500-10,000 CELLS/ ML), PLATELET COUNT OF 333,000/CUBIC MILLIMETER (NORMAL RANGE, 150,000- 400,000/MM3), HEMOGLOBIN LEVEL OF 15.0 G/DL (NORMAL RANGE, 13.8-17.2 G/DL), AND A HEMATOCRIT LEVEL OF 44.3% (NORMAL RANGE, 40.7%-50.3%). THE PRO- THROMBIN TIME WAS 12.6 SECONDS (NORMAL RANGE, 10-12 SECONDS); PARTIAL THROMBOPLASTIN TIME WAS 31 SECONDS (NORMAL RANGE, 30-45 SECONDS), AND INTERNATIONAL NORMALIZED RATIO VALUE WAS 0.97 (NORMAL RANGE, 1-2). IN CONSULTATION WITH THE ED PHYSICIANS, USE OF WHOLE BLOOD, FRESH FROZEN PLASMA, PACKED RED BLOOD CELLS, AND PLATELETS WOULD ALL BE CONSIDERED TO MAINTAIN THE PATIENT'S HEMOSTATIC VOLUME. AS LIGATION OF THE BLEEDING VESSEL IS THE PREFERRED TREATMENT TO TERMINATE BLEEDING, THIS IS OFTEN TIMES IMPOSSIBLE DUE TO THE LOCATION OF THE VESSEL AND SURGICAL ACCESS. SURGICAL MEASURES CONSIDERED TO OBTAIN DEFINITIVE CONTROL OF THE BLEEDING VESSEL INCLUDED EXPLORATORY SURGERY WITH SELECTIVE LIGATION OF THE BRANCHES OF THE EXTERNAL CAROTID ARTERY AND ARTERIAL EMBOLIZATION VIA- INTERVENTIONAL ANGIOGRAPHY. HOWEVER, AS THE AUTHORS WERE FAMILIAR WITH THE HEMOSTATIC AGENT FLOSEAL, THE DECISION WAS MADE TO APPLY THIS BIOACTIVE HEMOSTATIC AGENT TO THE OSTEOTOMY SITE IN THE ED BEFORE CONSIDERING TRANSFUSION OF BLOOD PRODUCTS AND SURGICAL INTERVENTION. WITH THE REMOVAL OF THE IMPLANT FROM THE OSTEOTOMY SITE, RESUMPTION OF BRISK, PULSATILE BLEEDING WAS OBSERVED. CONSTANT OOZING OF BLOOD WAS ALSO OBSERVED FROM THE OTHER OSTEOTOMY SITES WHEN THE GAUZE PACKS WERE REMOVED. DIRECT ACCESS TO THE INTRAOSSEOUS BLEEDING VESSEL WAS NOT POSSIBLE. FLOSEAL WAS PREPARED ACCORDING TO THE INSTRUCTIONS OF THE MANUFACTURER AND APPLIED TO THE IMPLANT OSTEOTOMY SITE WITH FIRM GAUZE PRESSURE. THROMBIN, 2500 INTER- NATIONAL UNITS, WAS RECONSTITUTED IN STERILE SALINE AND MIXED WITH THE COLLAGEN MATRIX. WITHIN 10 MINUTES AFTER THE APPLICATION OF FLOSEAL GEL TO THE OSTEOTOMY SITE WITH FIRM DIGITAL PRESSURE, BLEEDING MARKEDLY SLOWED. THE ACTIVE HEMOSTATIC AGENT WAS THEN APPLIED TO THE OTHER OSTEOTOMY SITES FOLLOWED BY FIRM GAUZE PRESSURE. AFTER 1 HOUR OF CONTINUED OBSERVATION, THE PROFUSE BLEEDING WAS ONLY OOZING FROM THE IMPLANT OSTEOTOMY SITES THEN. AFTER 4 HOURS OF FURTHER OBSERVATION IN THE ED, THE PATIENT WAS DISCHARGED TO HOME IN STABLE CONDITION. THROUGHOUT THE ENTIRE COURSE, THE PATIENT'S VITAL SIGNS REMAINED STABLE. IT WAS ESTIMATED THAT PATIENT'S BLOOD LOSS WAS APPROXIMATELY 300 ML. APPROXIMATELY 1 LITER OF CRYSTALLOID WAS TRANSFUSED TO THE PATIENT. THE PATIENT RETURNED TO THE OFFICE IN 1 WEEK FOR OBSERVATION OF THE SURGICAL SITE. HE REPORTED ONLY SPORADIC OOZING OF BLOOD FROM THE OSTEOTOMY SITES WHILE RECOVERING OVER THE NEXT 24 HOURS AT HOME. POSTOPERATIVE EDEMA AND ECCHYMOSIS PROVED TO BE THE MAIN CONCERN TO THE PATIENT RATHER THAN THE BLEEDING EPISODE. POSTOPERATIVE IMAGING STUDIES CONSISTING OF CBCT SCANS OF THE MANDIBLE WERE OBTAINED TO EVALUATE THE POSSIBLE CAUSE OF THE INTRAOPERATIVE BLEEDING. USING 3- DIMENSIONAL INTERACTIVE COMPUTER SOFTWARE (SIMPLANT, GLEN BURNIE, MD), DENTAL IMPLANT SURGERY USING TWIST DRILLS WAS SIMULATED AND IMPLANTS OF 15.0 MM IN LENGTH COULD VIOLATE THE NEUROVASCULAR STRUCTURES IN THE ANTERIOR MANDIBULAR INCISIVE CANAL (FIGS. 2 AND 3, A AND B). IT CAN BE OBSERVED THAT VIRTUAL IMPLANT PLACEMENT OF ALL 4 IMPLANTS WOULD ENCOUNTER THE NEUROVASCULAR BUNDLE OF THE MANDIBULAR INCISIVE CANAL THAT COULD LEAD TO IATROGENIC PROFUSE BLEEDING. DENTAL IMPLANT SURGERY IN THE ANTERIOR MANDIBLE IS A COMMON SURGICAL PROCEDURE THAT IS CONSIDERED RELATIVELY SAFE AND FREE OF COMPLICATIONS. WE BELIEVE THAT LACERATION OF THE VASCULAR STRUCTURES IN THE MANDIBULAR INCISIVE CANAL DURING THE IMPLANT OSTEOTOMY PROCEDURE WHILE USING A LONG TWIST DRILL WAS THE CAUSE FOR THE ACUTE PROFUSE HEMORRHAGE ENCOUNTERED INTRAOPERATIVELY. THIS CASE REPORT IS UNIQUE BECAUSE THE TREATMENT PLAN WAS TO PLACE 4 IMPLANTS OF 15.0 MM IN LENGTH INTO THE ANTERIOR MANDIBLE TO ACHIEVE PRIMARY IMPLANT STABILITY. TREATMENT USING LONG DENTAL IMPLANTS IN THE ANTERIOR MANDIBLE TO STABILIZE A MANDIBULAR OVERDENTURE IS CONSIDERED A SAFE AND ACCEPTABLE PROCEDURE, AS WELL AS OBTAINING BICORTICAL STABILIZATION. KNOWLEDGE OF SURGICAL ANATOMY IS CRITICAL, AS DIFFERENT IN-OFFICE SURGICAL PROCEDURES ARE ROUTINELY PERFORMED IN THE ANTERIOR MANDIBLE, SUCH AS DENTAL IMPLANT SURGERY, EXTRACTION OF TEETH, HARVESTING BONE FROM THE SYMPHYSIS OF THE CHIN, TORI REMOVAL, AND TRAUMA SURGERY TO REPAIR FRACTURES OF THE MANDIBLE. ALL OF THESE SURGICAL PROCEDURES MAY ACCIDENTLY RESULT IN SEVERE BLEEDING FROM THE MAN- DIBULAR INCISIVE CANAL. IF NOT EMERGENTLY MANAGED, THIS COMPLICATION MAY ESCALATE TO A SITUATION OF SIGNIFICANT BLOOD LOSS, OR PROGRESS TO A LIFE-THREATENING DISSECTING HEMATOMA IN THE FLOOR OF THE MOUTH THAT COULD LEAD TO RESPIRATORY OBSTRUCTION. THE CLINICIAN PERFORMING SURGERY IN THIS ANA- TOMICAL REGION MUST BE PREPARED TO MANAGE SUCH COMPLICATIONS. SEVERAL AUTHORS HAVE INVESTIGATED THE VASCULAR ANATOMY OF THE ANTERIOR MANDIBLE AND HEAD AND NECK REGION BY CADAVER DISSECTION, COMPUTED TOMOGRAPHY, AND ULTRASOUND. IN 1928, OLIVIER13 FIRST DESCRIBED THE MANDIBULAR INCISIVE NERVE AS A CONTINUATION OF THE INFERIOR ALVEOLAR NERVE FROM THE POSTERIOR MANDIBLE. OTHER AUTHORS HAVE DEFINED THE NEUROANATOMICAL STRUCTURES IN THIS LOCATION BY DIVIDING THE INFERIOR ALVEOLAR NERVE INTO BRANCHES OF THE MENTAL AND MANDIBULAR INCISIVE NERVE. THEY FURTHER DESCRIBED THE SUBLINGUAL AND SUBMENTAL ARTERIES AS ANASTOMOSING BRANCHES FROM THE EXTERNAL CAROTID ARTERY THAT ENTER THE MIDLINE OF THE ANTE- RIOR MANDIBLE VIA THE LINGUAL FORAMEN. STUDIES BY VANDEWALLE ET AL18 AND LIANG ET AL19 DESCRIBED THE NEUROVASCU- LAR ANATOMY OF THE ANTERIOR MANDIBLE AND FLOOR OF THE MOUTH. BOTH AUTHORS WERE IN AGREEMENT OF THE POTENTIAL INTRAOPERATIVE RISK OF NEUROVASCULAR INJURY WHILE PLACING DENTAL IMPLANTS IN THE ANTERIOR MANDIBLE DUE TO THE CLOSE PROX- IMITY OF THESE ANATOMICAL STRUCTURES. IN A CADAVER STUDY BY ROSANO ET AL,20 THEY EVALUATED 60 DRY MANDIBLES AND RECOMMENDED AGAINST THE USE OF SURGICALLY PLACING LONG IMPLANTS TO AVOID THE RISK OF SURGICAL TRAUMA TO THE LINGUAL CORTICAL PLATE THAT COULD LEAD TO SEVERE BLEEDING IN THE FLOOR OF THE MOUTH. MAKRIS ET AL,21 USING CBCT SCANS OBTAINED FROM 100 PATIENTS, EVALUATED THE VISIBILITY OF THE INCISIVE CANAL AND LINGUAL FORAMEN. THE INCISIVE CANAL WAS VISIBLE IN 83.5% OF THE SCANS. THE MEAN END POINT WAS APPROXIMATELY 15 MM ANTERIOR TO THE MENTAL FORAMEN. THE MEAN DISTANCE FROM THE INFERIOR BORDER OF THE MANDIBLE WAS 11.5 MM. THE LINGUAL FORAMEN WAS VISIBLE IN 81% OF THE SCANS. THE RESULTS OF THIS STUDY DEMONSTRATE THE POTENTIAL RISK OF IATROGENIC INJURY TO THE VASCULAR STRUCTURES IN THE ANTERIOR MANDIBLE DUR- ING IMPLANT PREPARATION THAT COULD LEAD TO HEMORRHAGIC EPISODES. PROFUSE, PULSATILE, AND BRISK BLEEBING FROM DENTAL IMPLANT SURGERY IN THE ANTERIOR MANDIBLE IS UNCOMMON. ALTHOUGH OUR CASE DID NOT PROGRESS TO A LIFETHREATENING SITUATION, INTRAOPERATIVE BLEEDING CAN BECOME SUBSTANTIAL AND PROGRESS TO A LIFE-THREATENING SITUATION. IT HAS BEEN ESTIMATED THAT 400 ML OF BLOOD COULD BE DRAINED FROM A BLOOD VESSEL WITH AN INTRAVASCULAR DIAMETER OF 1 TO 2 MM IN 30 MINUTES.22 BLEEDING THAT IS DIFFICULT TO CONTROL OR INEFFECTIVE IS ALWAYS A CHALLENGE TO THE SURGEON. THE SURGEON MUST REMAIN COMPOSED AND CALM TO ARREST THE BLEEDING. PROMPT RECOGNITION AND MANAGEMENT OF THE SOURCE OF BLEEDING WITH ANY SURGICAL PROCEDURE IS CRITICAL TO AVOID PROGRESSION TO SEVERE LIFETHREATENING COMPLICATIONS. HEMOSTATIC STRATEGIES KNOWLEDGE IN THE MECHANISM OF HEMOSTASIS IS CRITICAL IN THE OVERALL OUT- COME OF THE SURGICAL PATIENT. HEMOSTASIS CONSISTS OF A SERIES OF COORDINATED, COMPLEX REACTIONS IN THE COAGULATION CASCADE THAT INVOLVES THE PLATELETS AND BLOOD VESSEL WALL. WHEN INTRAOPERATIVE BLEEDING IS ENCOUNTERED, THE SURGEON HAS SEVERAL OPTIONS TO TERMINATE THE BLEEDING. THESE INCLUDE MECHANICAL AND THERMAL METHODS, TO THE USE OF PHARMACOLOGIC AND TOPICAL AGENTS. ATTEMPTS TO CONTROL INTRAOPERATIVE BLEEDING ARE DEPENDENT ON MANY VARIABLES, BUT INITIALLY, THEY RELY ON DIRECT PRESSURE OR COMPRESSION WITH GAUZE PACKING AT THE BLEEDING SITE. MECHANICAL METHODS CONSIST OF THE USE OF SUTURES TO LIGATE THE SOURCE OF BLEEDING, STAPLES, AND LIGATING CLIPS.26 HOWEVER, THESE TECHNIQUES CAN BE APPLIED IF THE SOURCE OF BLEEDING IS IDENTIFIED AND VISUALIZED. THERMAL TECHNIQUES USING LASERS AND ELECTROCAUTERY ARE OPTIONS AVAILABLE TO THE SURGEON BUT MAY BE UNAVAILABLE IN THE OFFICE SETTING. MECHANICAL AND THERMAL TECHNIQUES MAY NOT ALWAYS BE ABLE TO EFFECTIVELY CONTROL THE SOURCE OF BLEEDING, SUCH AS IN BONY STRUCTURES, INFLAMED SOFT TISSUES, AND DIFFUSE BLEEDING CAPILLARIES. IN THESE INSTANCES, THE USE OF PHARMACOLOGIC AGENTS MIGHT BE MORE APPROPRIATE. THESE AGENTS ARE USED TO ENHANCE THE COAGULATION CASCADE OF THE PATIENT AND INCLUDE INJECTION OF LOCAL ANESTHETIC THAT CONTAINS EPINEPHRINE, TISSUE ADHESIVES, AND TOPICAL HEMOSTATS. IN THE OFFICE SETTING, THE SURGEON SHOULD HAVE SEVERAL DIFFERENT TYPES OF HEMOSTATIC PRODUCTS AVAILABLE TO CONTROL AND ARREST BLEEDING. TOPICAL HEMOSTATS ARE DIVIDED INTO 2 CATEGORIES: PASSIVE AND ACTIVE. PASSIVE ABSORBABLE HEMOSTATS ARE USED TO APPLY DIRECT PRES- SURE TO TAMPONADE THE HEMORRHAGE AND INCLUDE COLLAGEN SPONGES, GELATINS, AND CELLULOSE. BIOLOGICALLY ACTIVE TOPICAL HEMOSTATS ARE THROMBIN AND COMBINATION PRODUCTS THAT CONTAIN THROMBIN, SUCH AS FLOSEAL. IN OUR CASE, ATTEMPTS TO CONTROL THE PROFUSE, BRISK, PULSATILE BLEEDING IN THE OFFICE WITH VARIOUS TOPICAL HEMOSTATIC MEASURES PROVED UNSUCCESSFUL. LIGATION OF A BLEEDING VESSEL IS THE TREATMENT OF CHOICE, BUT IT IS OFTEN DIFFICULT OR IMPOSSIBLE DUE TO SURGICAL ACCESS AND ANATOMY. THIS PROVED TO BE THE SITUATION IN OUR PATIENT. THEREFORE, ONCE IN THE ED, THE DECISION WAS MADE TO USE AN ACTIVE BIOACTIVE HEMOSTAT, SUCH AS FLOSEAL. ALTHOUGH FLOSEAL IS NOT AVAILABLE FOR IN-OFFICE USE, CLINICIANS WHO PERFORM SURGERY SHOULD BE AWARE OF THIS HEMOSTATIC PRODUCT TO CONTROL BLEEDING THAT RANGES FROM OOZING TO ARTERIAL SPURTING. THIS UNIQUE CHARACTERISTIC OF TISSUE EXPANSION IN THE AREA OF BLEEDING IS THE PRIMARY MECHANISM FOR TERMINATING THE SOURCE OF BLEEDING. DURING THIS PROCESS, THROMBIN ACTS ON THE PATIENT'S COAGULATION CASCADE BY CONVERTING FIBRINOGEN TO FIBRIN.25,27,33 THIS ACTIVITY PERMITS THE FIBRIN CLOT TO INTEGRATE WITH THE FLOSEAL MATRIX PARTICLES THAT WILL FORM A FLOSEAL-FIBRIN MATRIX CLOT THAT HAS A TAMPONADING EFFECT ON THE BLEEDING VESSEL WALL.27 IN OUR CASE, FLOSEAL WAS ABLE TO SIGNIFICANTLY REDUCE AND TERMINATE THE BLEEDING WHEN ALL OTHER TOPICAL HEMOSTATIC MEASURES FAILED DUE TO ITS BIOLOGIC AND MECHANICAL PROPERTIES. WE RECOMMEND THAT FLOSEAL SHOULD BE CONSIDERED IN CASES WHERE INTRA- OPERATIVE AND POSTOPERATIVE BLEEDING BECOMES PROBLEMATIC. HOWEVER, THE SURGEON MUST BE AWARE OF THE LIMITATIONS OF ALL TOPICAL HEMOSTATIC AGENTS. LIKE OTHER TOPICAL HEMOSTATIC AGENTS, FLOSEAL WILL PROBABLY NOT STOP HIGH- PRESSURE TYPES OF BLEEDING. IN THESE INSTANCES, OTHER CONVENTIONAL SURGICAL MEANS SHOULD BE CONSIDERED. THIS CASE REPORT DETAILS AN UNEXPECTED, IN-OFFICE, INTRAOPERATIVE VASCULAR COMPLICATION IN THE ANTERIOR MANDIBLE DURING IMPLANT SURGERY THAT IS CONSIDERED APPROPRIATE AND THE STANDARD OF CARE. PREVIOUS REPORTS DEMONSTRATING LIFE-THREATENING HEMORRHAGE AND HEMATOMA FORMATION IN THE FLOOR OF THE MOUTH LEADING TO RESPIRATORY OBSTRUCTION HAVE BEEN REPORTED. IN MANY OF THESE CASES, A DRILLING DEPTH OF 15 MM DURING IMPLANT OSTEOTOMY PREPARATION WAS THE CAUSE OF ARTERIAL INJURY THROUGH MISANGULATION OF THE BUR THROUGH THE LINGUAL CORTICAL PLATE. THEREFORE, THE LENGTH OF IMPLANTS TO BE PLACED IN THE ANTERIOR MANDIBLE SHOULD BE CAREFULLY CONSIDERED. SEVERAL AUTHORS ARE OF THE OPINION THAT BICORTICAL STABILIZATION IN THE ANTERIOR MANDIBLE IS NO LONGER NECESSARY FOR IMPLANT SUCCESS, AND THE BENEFITS VERSUS THE RISKS OF PLACING IMPLANTS LONGER THAN 13 MM SHOULD BE CAREFULLY CONSIDERED. WE ARE IN AGREEMENT WITH THE AUTHORS, AS OUR CASE REPORT DEMONSTRATES THAT ATTEMPTING TO PLACE LONG IMPLANTS IN THE ANTERIOR MANDIBLE MAY VIOLATE THE NEUROVASCULAR CONTENTS WITHIN THE MANDIBULAR INCISIVE CANAL THAT COULD ALSO LEAD TO ARTERIAL BLEEDING. NO FOLLOW UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. COMMENT: THE REPORTED BRISK BLEEDING WAS CONSIDERED AS DUE TO DENTAL IMPLANTS, AND NOT CAUSALLY RELATED TO ITS TREATMENT/INTERVENTION WITH HEMOSTATS INCLUDING GELATIN AND THROMBIN.
EVENT VERBATIM [PREFERRED TERM] AS A FINAL MEASURE TO STOP THE BLEEDING, TOPICAL BOVINE THROMBIN (THROMBINE-JMI, PFIZER, NEW YORK, NY) WAS APPLIED TO ARREST THE HEMORRHAGING, BUT TO NO AVAIL [DRUG INEFFECTIVE] , . CASE NARRATIVE:THIS LITERATURE REPORT IS BASED ON THE JOURNAL OF THE IMPLANT DENTISTRY, (YEAR 2012) VOL 21(5): (PGS. 368-373) ENTITLED[BRISK, PULSATILE BLEEDING FROM THE ANTERIOR MANDIBULAR INCISIVE CANAL DURING IMPLANT SURGERY: A CASE REPORT AND USE OF AN ACTIVE HEMOSTATIC MATRIX TO TERMINATE ACUTE BLEEDING.] A 69-YEAR-OLD ASIAN MAN WAS TREATMENT PLANNED FOR THE EXTRACTION OF THE 3 REMAINING MANDIBULAR ANTERIOR TEETH FOLLOWED BY IMMEDIATE IMPLANT PLACEMENT OF 4 DENTAL IMPLANTS TO SUPPORT A COMPLETE OVERDENTURE AND BAR (FIG. 1). THE PATIENT'S MEDICAL HISTORY WAS UNREMARKABLE AND NEGATIVE FOR COAGULOPATHIES. HE WAS NOT PRESCRIBED ANY MEDICATIONS AND DENIED HAVING ANY ALLERGIES TO MEDICATION. BEFORE SURGERY, A FORMAL WORKUP WAS PERFORMED THAT INCLUDED IMAGING STUDIES CONSISTING OF A PANORAMIC RADIOGRAPH AND CONE BEAM COMPUTED TOMOGRAPHY (CBCT) WITH 3-DIMENSIONAL INTERACTIVE COMPUTER SOFTWARE TO EVALUATE THE ANTERIOR MANDIBLE FOR IMPLANT PLACEMENT IN THE INTER-FORAMINAL REGION. BASED ON THE IMAGING STUDIES, THERE WAS SATISFACTORY BONE VOLUME IN ALL 3 DIMENSIONS FOR IMPLANT PLACEMENT IN THE ANTERIOR MANDIBLE. A TREATMENT PLAN WAS FORMULATED WHERE FOUR 3.5 MM 3 15.0 MM IMPLANTS WOULD BE IMMEDIATELY PLACED IN THE INTERFORAMINAL REGION TO SUPPORT A COMPLETE MANDIBULAR OVERDENTURE AFTER THE TEETH WERE EXTRACTED, AND AN ALVEOLECTOMY WAS PERFORMED. USE OF LONG IMPLANTS AND BICORTICAL STABILIZATION ARE ACCEPTED STANDARDS OF CARE TO ACHIEVE PRIMARY IMPLANT STABILITY TO OBTAIN OSSEOINTEGRATION AND SUPPORT OVERDENTURES IN THE ANTERIOR MANDIBLE. SURGERY WAS PERFORMED UNDER LOCAL ANESTHESIA VIA BILATERAL MANDIBULAR NERVE BLOCKS AND SOFT TISSUE INFILTRATION INTO THE BUCCAL AND ANTERIOR LABIAL VESTIBULE OF THE MANDIBLE. AFTER A STANDARD MUCOPERIOSTEAL INCISION WAS MADE, THE SOFT TISSUE FLAP WAS DEVELOPED AND REFLECTED OFF OF THE MANDIBLE. THE TEETH WERE EXTRACTED (NUMBERS 22, 23, AND 27), AND AN ALVEOLOPLASTY PROCEDURE WAS PERFORMED TO REMOVE THE SHARP BONE SPICULES AND UNDERCUTS WITHOUT EVENT. PREPARATION AND DRILLING OF THE 4 IMPLANT OSTEOTOMY SITES (22, 24, 25, AND 27 AREAS) WERE FOLLOWED ACCORDING TO THE INSTRUCTIONS OF THE IMPLANT MANUFACTURER. WHILE PREPARING THE 4 IMPLANT OSTEOTOMY SITES USING TWIST DRILLS OF VARYING DIAMETER, A BRISK, PULSATILE BLEED WAS ENCOUNTERED FROM THE IMPLANT OSTEOTOMY SITE IN THE LEFT CANINE REGION. THE SOURCE OF THE BLEEDING WAS IMMEDIATELY IDENTIFIED AS COMING FROM WITHIN THE OSTEOTOMY SITE AND NOT THE FLOOR OF THE MANDIBULAR INCISIVE CANAL THAT COULD RESULT IN IATROGENIC BLEEDING. INITIAL HEMOSTATIC MEASURES WERE APPLIED TO THE OSTEOTOMY SITE, SUCH AS GAUZE DIGITAL PRESSURE TO TAMPONADE THE HEMORRHAGE, WHICH WAS PROVED UNSUCCESSFUL. USE OF VARIOUS HEMO- STATIC AGENTS, SUCH AS ABSORBABLE GELATIN SPONGES (GEL FOAM; PHARMACIA AND UPJOHN, CO, KALAMAZOO, MI), MICROFIBRILLAR COLLAGEN (AVITENE; CR BARD, INC, MURRAY HILL, NJ), AND OXIDIZED CELLULOSE, (SURGICEL; ETHICON, INC, SOMER- VILLE, NJ), APPLIED TO THE BLEEDING OSTEOTOMY SITE FAILED TO STOP THE BLEEDING. THE BLEEDING WAS VERY BRISK, AS ATTEMPTS TO PLACE THE HEMOSTATIC AGENTS INTO THE OSTEOTOMY SITE WERE UNSUCCESSFUL, AS THEY WOULD IMMEDIATELY FLOW BACK UP AND OUT OF THE OSTEOTOMY SITE. AS A FINAL MEASURE TO STOP THE BLEEDING, TOPICAL BOVINE THROMBIN (THROMBINE-JMI, PFIZER, NEW YORK, NY) WAS APPLIED TO ARREST THE HEMORRHAGING BUT TO NO AVAIL. AS ALL LOCAL HEMOSTATIC MANEUVERS FAILED TO CONTROL THE BRISK, PULSATILE BLEEDING FROM THE IMPLANT SITE, AN IMPLANT WAS PLACED INTO THE OSTEOTOMY SITE, SIMILAR TO CAPPING OFF A SPOUTING OIL WELL. WITH THE IMPLANT PLACED INTO THE OSTEOTOMY SITE, THE BRISK, PULSATILE BLEEDING WAS OBSERVED TO HAVE FINALLY SLOWED FROM THE IMPLANT SITE. HOWEVER, INSPECTION OF THE ANTERIOR MANDIBLE REVEALED THAT THE BLEEDING HAD NOT BEEN TOTALLY ARRESTED BECAUSE SLOW BLEEDING WAS NOW OBSERVED FROM THE OTHER IMPLANT OSTEOTOMY SITES (23 AND 24 AREAS). DURING THE ENTIRE ACUTE HEMORRHAGIC EPISODE, THE PATIENT WAS CON- STANTLY MONITORED AND DID NOT DEMONSTRATE ANY CLINICAL SIGNS OF CARDIAC INSTABILITY AND RESPIRATORY DISTRESS, SUCH AS FLOOR OF MOUTH EDEMA OR TONGUE ELEVATION THAT COULD LEAD TO RESPIRATORY OBSTRUCTION. PATENCY OF THE PATIENT'S AIRWAY WAS ALWAYS A TOP PRIORITY. AS ALL LOCAL HEMOSTATIC MEASURES FAILED TO ARREST THE BLEEDING, THE DECISION WAS MADE TO TRANSPORT THE PATIENT ACCOMPANIED BY THE SURGEON (C.Y.S.L.) TO THE EMERGENCY DEPARTMENT (ED) OF A NEARBY HOSPITAL 10 MINUTES AWAY FROM THE OFFICE FOR CONTINUED TREATMENT OF THE PROFUSE ARTERIAL BLEEDING AND TO MANAGE ANY POTENTIAL MEDICAL COMPLICATIONS, SUCH AS FLUID VOLUME RESUSCITATION AND AIRWAY OBSTRUCTION. IN ADDITION, LABORATORY VALUES COULD BE OBTAINED TO MONITOR THE PATIENT'S HEMODYNAMIC CONDITION. ON ADMISSION TO THE ED, THE PATIENT PRESENTED WITH A BLOOD PRESSURE OF 205/102 MM HG AND A PULSE RATE OF 83 BEATS/MINUTE. HE DENIED HAVING A SIGNIFICANT MEDICAL HISTORY AND DENIED TAKING ANY MEDICATIONS. THE PATIENT HAD NO KNOWN ALLERGIES TO MEDICATION AND DENIED TOBACCO USE BUT ADMITTED TO OCCASIONAL ALCOHOL USE. THE PHYSICAL EXAMINATION WAS UNREMARKABLE. THE ABDOMEN WAS SOFT AND NONDISTENDED. NO HEPATOSPLENOMEGALY WAS OBSERVED. THE CARDIOVASCULAR AND PULMONARY EXAMINATIONS WERE UNREMARKABLE. UNDER CONSTANT MONITORING IN THE ED, THE PATIENT DID NOT DEMONSTRATE ANY PROGRESSIVE SIGNS AND SYMPTOMS OF RESPIRATORY DISTRESS OR HYPOVOLEMIC COMPROMISE. HOWEVER, IF THE PATIENT DEMONSTRATED ANY EVIDENCE OF ACUTE RESPIRATORY DISTRESS, IT WAS DECIDED THAT THE PATIENT WOULD BE PROPHYLACTICALLY INTUBATED TO MAINTAIN THE AIRWAY. BASELINE LABORATORY VALUES IMMEDIATELY OBTAINED IN THE ED DEMONSTRATED A RED BLOOD CELL COUNT OF 5.01 (NORMAL RANGE, 4.7-6.1 MILLION CELLS/ML), WHITE BLOOD CELL COUNT OF 10.0 (NORMAL RANGE, 4500-10,000 CELLS/ ML), PLATELET COUNT OF 333,000/CUBIC MILLIMETER (NORMAL RANGE, 150,000- 400,000/MM3), HEMOGLOBIN LEVEL OF 15.0 G/DL (NORMAL RANGE, 13.8-17.2 G/DL), AND A HEMATOCRIT LEVEL OF 44.3% (NORMAL RANGE, 40.7%-50.3%). THE PRO- THROMBIN TIME WAS 12.6 SECONDS (NORMAL RANGE, 10-12 SECONDS); PARTIAL THROMBO- PLASTIN TIME WAS 31 SECONDS (NORMAL RANGE, 30-45 SECONDS), AND INTERNATIONAL NORMALIZED RATIO VALUE WAS 0.97 (NORMAL RANGE, 1-2). IN CONSULTATION WITH THE ED PHYSICIANS, USE OF WHOLE BLOOD, FRESH FROZEN PLASMA, PACKED RED BLOOD CELLS, AND PLATELETS WOULD ALL BE CONSIDERED TO MAINTAIN THE PATIENT'S HEMOSTATIC VOLUME. AS LIGATION OF THE BLEEDING VESSEL IS THE PREFERRED TREATMENT TO TERMINATE BLEEDING, THIS IS OFTEN TIMES IMPOSSIBLE DUE TO THE LOCATION OF THE VESSEL AND SURGICAL ACCESS. SURGICAL MEASURES CONSIDERED TO OBTAIN DEFINITIVE CONTROL OF THE BLEEDING VESSEL INCLUDED EXPLORATORY SURGERY WITH SELECTIVE LIGATION OF THE BRANCHES OF THE EXTERNAL CAROTID ARTERY AND ARTERIAL EMBOLIZATION VIA- INTERVENTIONAL ANGIOGRAPHY. HOWEVER, AS THE AUTHORS WERE FAMILIAR WITH THE HEMOSTATIC AGENT FLOSEAL, THE DECISION WAS MADE TO APPLY THIS BIOACTIVE HEMOSTATIC AGENT TO THE OSTEOTOMY SITE IN THE ED BEFORE CONSIDERING TRANSFUSION OF BLOOD PRODUCTS AND SURGICAL INTERVENTION. WITH THE REMOVAL OF THE IMPLANT FROM THE OSTEOTOMY SITE, RESUMPTION OF BRISK, PULSATILE BLEEDING WAS OBSERVED. CONSTANT OOZING OF BLOOD WAS ALSO OBSERVED FROM THE OTHER OSTEOTOMY SITES WHEN THE GAUZE PACKS WERE REMOVED. DIRECT ACCESS TO THE INTRAOSSEOUS BLEEDING VESSEL WAS NOT POSSIBLE. FLOSEAL WAS PREPARED ACCORDING TO THE INSTRUCTIONS OF THE MANUFACTURER AND APPLIED TO THE IMPLANT OSTEOTOMY SITE WITH FIRM GAUZE PRESSURE. THROMBIN, 2500 INTER- NATIONAL UNITS, WAS RECONSTITUTED IN STERILE SALINE AND MIXED WITH THE COLLAGEN MATRIX. WITHIN 10 MINUTES AFTER THE APPLICATION OF FLOSEAL GEL TO THE OSTEOTOMY SITE WITH FIRM DIGITAL PRESSURE, BLEEDING MARKEDLY SLOWED. THE ACTIVE HEMOSTATIC AGENT WAS THEN APPLIED TO THE OTHER OSTEOTOMY SITES FOLLOWED BY FIRM GAUZE PRESSURE. AFTER 1 HOUR OF CONTINUED OBSERVATION, THE PROFUSE BLEEDING WAS ONLY OOZING FROM THE IMPLANT OSTEOTOMY SITES THEN. AFTER 4 HOURS OF FURTHER OBSERVATION IN THE ED, THE PATIENT WAS DISCHARGED TO HOME IN STABLE CONDITION. THROUGHOUT THE ENTIRE COURSE, THE PATIENT'S VITAL SIGNS REMAINED STABLE. IT WAS ESTIMATED THAT PATIENT'S BLOOD LOSS WAS APPROXIMATELY 300 ML. APPROXIMATELY 1 LITER OF CRYSTALLOID WAS TRANSFUSED TO THE PATIENT. THE PATIENT RETURNED TO THE OFFICE IN 1 WEEK FOR OBSERVATION OF THE SURGICAL SITE. HE REPORTED ONLY SPORADIC OOZING OF BLOOD FROM THE OSTEOTOMY SITES WHILE RECOVERING OVER THE NEXT 24 HOURS AT HOME. POSTOPERATIVE EDEMA AND ECCHYMOSIS PROVED TO BE THE MAIN CONCERN TO THE PATIENT RATHER THAN THE BLEEDING EPISODE. POSTOPERATIVE IMAGING STUDIES CONSISTING OF CBCT SCANS OF THE MANDIBLE WERE OBTAINED TO EVALUATE THE POSSIBLE CAUSE OF THE INTRAOPERATIVE BLEEDING. USING 3-DIMENSIONAL INTERACTIVE COMPUTER SOFTWARE (SIMPLANT, GLEN BURNIE, MD), DENTAL IMPLANT SURGERY USING TWIST DRILLS WAS SIMULATED AND IMPLANTS OF 15.0 MM IN LENGTH COULD VIOLATE THE NEUROVASCULAR STRUCTURES IN THE ANTERIOR MANDIBULAR INCISIVE CANAL (FIGS. 2 AND 3, A AND B). IT CAN BE OBSERVED THAT VIRTUAL IMPLANT PLACEMENT OF ALL 4 IMPLANTS WOULD ENCOUNTER THE NEUROVASCULAR BUNDLE OF THE MANDIBULAR INCISIVE CANAL THAT COULD LEAD TO IATROGENIC PROFUSE BLEEDING. DENTAL IMPLANT SURGERY IN THE ANTERIOR MANDIBLE IS A COMMON SURGICAL PROCEDURE THAT IS CONSIDERED RELATIVELY SAFE AND FREE OF COMPLICATIONS. WE BELIEVE THAT LACERATION OF THE VASCULAR STRUCTURES IN THE MANDIBULAR INCISIVE CANAL DURING THE IMPLANT OSTEOTOMY PROCEDURE WHILE USING A LONG TWIST DRILL WAS THE CAUSE FOR THE ACUTE PROFUSE HEMORRHAGE ENCOUNTERED INTRAOPERATIVELY. THIS CASE REPORT IS UNIQUE BECAUSE THE TREATMENT PLAN WAS TO PLACE 4 IMPLANTS OF 15.0 MM IN LENGTH INTO THE ANTERIOR MANDIBLE TO ACHIEVE PRIMARY IMPLANT STABILITY. TREATMENT USING LONG DENTAL IMPLANTS IN THE ANTERIOR MANDIBLE TO STABILIZE A MANDIBULAR OVERDENTURE IS CONSIDERED A SAFE AND ACCEPTABLE PROCEDURE, AS WELL AS OBTAINING BICORTICAL STABILIZATION. KNOWLEDGE OF SURGICAL ANATOMY IS CRITICAL, AS DIFFERENT IN-OFFICE SURGICAL PROCEDURES ARE ROUTINELY PERFORMED IN THE ANTERIOR MANDIBLE, SUCH AS DENTAL IMPLANT SURGERY, EXTRACTION OF TEETH, HARVESTING BONE FROM THE SYMPHYSIS OF THE CHIN, TORI REMOVAL, AND TRAUMA SURGERY TO REPAIR FRACTURES OF THE MANDIBLE. ALL OF THESE SURGICAL PROCEDURES MAY ACCIDENTLY RESULT IN SEVERE BLEEDING FROM THE MAN- DIBULAR INCISIVE CANAL. IF NOT EMERGENTLY MANAGED, THIS COMPLICATION MAY ESCALATE TO A SITUATION OF SIGNIFICANT BLOOD LOSS, OR PROGRESS TO A LIFE-THREATENING DISSECTING HEMATOMA IN THE FLOOR OF THE MOUTH THAT COULD LEAD TO RESPIRATORY OBSTRUCTION. THE CLINICIAN PERFORMING SURGERY IN THIS ANA- TOMICAL REGION MUST BE PREPARED TO MANAGE SUCH COMPLICATIONS. SEVERAL AUTHORS HAVE INVESTIGATED THE VASCULAR ANATOMY OF THE ANTERIOR MANDIBLE AND HEAD AND NECK REGION BY CADAVER DISSECTION, COMPUTED TOMOGRAPHY, AND ULTRASOUND. IN 1928, OLIVIER13 FIRST DESCRIBED THE MANDIBULAR INCISIVE NERVE AS A CONTINUATION OF THE INFERIOR ALVEOLAR NERVE FROM THE POSTERIOR MANDIBLE. OTHER AUTHORS HAVE DEFINED THE NEUROANATOMICAL STRUCTURES IN THIS LOCATION BY DIVIDING THE INFERIOR ALVEOLAR NERVE INTO BRANCHES OF THE MENTAL AND MANDIBULAR INCISIVE NERVE. THEY FURTHER DESCRIBED THE SUBLINGUAL AND SUBMENTAL ARTERIES AS ANASTOMOSING BRANCHES FROM THE EXTERNAL CAROTID ARTERY THAT ENTER THE MIDLINE OF THE ANTE- RIOR MANDIBLE VIA THE LINGUAL FORAMEN. STUDIES BY VANDEWALLE ET AL18 AND LIANG ET AL19 DESCRIBED THE NEUROVASCU- LAR ANATOMY OF THE ANTERIOR MANDIBLE AND FLOOR OF THE MOUTH. BOTH AUTHORS WERE IN AGREEMENT OF THE POTENTIAL INTRA- OPERATIVE RISK OF NEUROVASCULAR INJURY WHILE PLACING DENTAL IMPLANTS IN THE ANTERIOR MANDIBLE DUE TO THE CLOSE PROX- IMITY OF THESE ANATOMICAL STRUCTURES. IN A CADAVER STUDY BY ROSANO ET AL,20 THEY EVALUATED 60 DRY MANDIBLES AND RECOMMENDED AGAINST THE USE OF SURGICALLY PLACING LONG IMPLANTS TO AVOID THE RISK OF SURGICAL TRAUMA TO THE LINGUAL CORTICAL PLATE THAT COULD LEAD TO SEVERE BLEEDING IN THE FLOOR OF THE MOUTH. MAKRIS ET AL,21 USING CBCT SCANS OBTAINED FROM 100 PATIENTS, EVALUATED THE VISIBILITY OF THE INCISIVE CANAL AND LINGUAL FORAMEN. THE INCISIVE CANAL WAS VISIBLE IN 83.5% OF THE SCANS. THE MEAN END POINT WAS APPROXIMATELY 15 MM ANTERIOR TO THE MENTAL FORAMEN. THE MEAN DISTANCE FROM THE INFERIOR BORDER OF THE MANDIBLE WAS 11.5 MM. THE LINGUAL FORAMEN WAS VISIBLE IN 81% OF THE SCANS. THE RESULTS OF THIS STUDY DEMONSTRATE THE POTENTIAL RISK OF IATROGENIC INJURY TO THE VASCULAR STRUCTURES IN THE ANTERIOR MANDIBLE DUR- ING IMPLANT PREPARATION THAT COULD LEAD TO HEMORRHAGIC EPISODES. PROFUSE, PULSATILE, AND BRISK BLEEBING FROM DENTAL IMPLANT SURGERY IN THE ANTERIOR MANDIBLE IS UNCOMMON. ALTHOUGH OUR CASE DID NOT PROGRESS TO A LIFE-THREATENING SITUATION, INTRAOPERATIVE BLEEDING CAN BECOME SUBSTANTIAL AND PROGRESS TO A LIFE-THREATENING SITUATION. IT HAS BEEN ESTIMATED THAT 400 ML OF BLOOD COULD BE DRAINED FROM A BLOOD VESSEL WITH AN INTRAVASCULAR DIAMETER OF 1 TO 2 MM IN 30 MINUTES.22 BLEEDING THAT IS DIFFICULT TO CONTROL OR INEFFECTIVE IS ALWAYS A CHALLENGE TO THE SURGEON. THE SURGEON MUST REMAIN COMPOSED AND CALM TO ARREST THE BLEEDING. PROMPT RECOGNITION AND MANAGEMENT OF THE SOURCE OF BLEEDING WITH ANY SURGICAL PROCEDURE IS CRITICAL TO AVOID PROGRESSION TO SEVERE LIFE-THREATENING COMPLICATIONS. HEMOSTATIC STRATEGIES KNOWLEDGE IN THE MECHANISM OF HEMOSTASIS IS CRITICAL IN THE OVERALL OUT- COME OF THE SURGICAL PATIENT. HEMOSTASIS CONSISTS OF A SERIES OF COORDINATED, COMPLEX REACTIONS IN THE COAGULATION CASCADE THAT INVOLVES THE PLATELETS AND BLOOD VESSEL WALL. WHEN INTRAOPERATIVE BLEEDING IS ENCOUNTERED, THE SURGEON HAS SEVERAL OPTIONS TO TERMINATE THE BLEEDING. THESE INCLUDE MECHANICAL AND THERMAL METHODS, TO THE USE OF PHARMACOLOGIC AND TOPICAL AGENTS. ATTEMPTS TO CONTROL INTRAOPERATIVE BLEEDING ARE DEPENDENT ON MANY VARIABLES, BUT INITIALLY, THEY RELY ON DIRECT PRESSURE OR COMPRESSION WITH GAUZE PACKING AT THE BLEEDING SITE. MECHANICAL METHODS CONSIST OF THE USE OF SUTURES TO LIGATE THE SOURCE OF BLEEDING, STAPLES, AND LIGATING CLIPS.26 HOWEVER, THESE TECHNIQUES CAN BE APPLIED IF THE SOURCE OF BLEEDING IS IDENTIFIED AND VISUALIZED. THERMAL TECHNIQUES USING LASERS AND ELECTROCAUTERY ARE OPTIONS AVAILABLE TO THE SURGEON BUT MAY BE UNAVAILABLE IN THE OFFICE SETTING. MECHANICAL AND THERMAL TECHNIQUES MAY NOT ALWAYS BE ABLE TO EFFECTIVELY CONTROL THE SOURCE OF BLEEDING, SUCH AS IN BONY STRUCTURES, INFLAMED SOFT TISSUES, AND DIFFUSE BLEEDING CAPILLARIES. IN THESE INSTANCES, THE USE OF PHARMACOLOGIC AGENTS MIGHT BE MORE APPROPRIATE. THESE AGENTS ARE USED TO ENHANCE THE COAGULATION CASCADE OF THE PATIENT AND INCLUDE INJECTION OF LOCAL ANESTHETIC THAT CONTAINS EPINEPHRINE, TISSUE ADHESIVES, AND TOPICAL HEMOSTATS. IN THE OFFICE SETTING, THE SURGEON SHOULD HAVE SEVERAL DIFFERENT TYPES OF HEMOSTATIC PRODUCTS AVAILABLE TO CONTROL AND ARREST BLEEDING. TOPICAL HEMOSTATS ARE DIVIDED INTO 2 CATEGORIES: PASSIVE AND ACTIVE. PASSIVE ABSORBABLE HEMOSTATS ARE USED TO APPLY DIRECT PRES- SURE TO TAMPONADE THE HEMORRHAGE AND INCLUDE COLLAGEN SPONGES, GELATINS, AND CELLULOSE. BIOLOGICALLY ACTIVE TOPICAL HEMOSTATS ARE THROMBIN AND COMBINATION PRODUCTS THAT CONTAIN THROMBIN, SUCH AS FLOSEAL. IN OUR CASE, ATTEMPTS TO CONTROL THE PROFUSE, BRISK, PULSATILE BLEEDING IN THE OFFICE WITH VARIOUS TOPICAL HEMOSTATIC MEASURES PROVED UNSUCCESSFUL. LIGATION OF A BLEEDING VESSEL IS THE TREATMENT OF CHOICE, BUT IT IS OFTEN DIFFICULT OR IMPOSSIBLE DUE TO SURGICAL ACCESS AND ANATOMY. THIS PROVED TO BE THE SITUATION IN OUR PATIENT. THEREFORE, ONCE IN THE ED, THE DECISION WAS MADE TO USE AN ACTIVE BIOACTIVE HEMOSTAT, SUCH AS FLOSEAL. ALTHOUGH FLOSEAL IS NOT AVAIL- ABLE FOR IN-OFFICE USE, CLINICIANS WHO PERFORM SURGERY SHOULD BE AWARE OF THIS HEMOSTATIC PRODUCT TO CONTROL BLEEDING THAT RANGES FROM OOZING TO ARTERIAL SPURTING. THIS UNIQUE CHARACTERISTIC OF TISSUE EXPANSION IN THE AREA OF BLEEDING IS THE PRIMARY MECHANISM FOR TERMINATING THE SOURCE OF BLEEDING. DURING THIS PROCESS, THROMBIN ACTS ON THE PATIENT'S COAGULATION CASCADE BY CONVERTING FIBRINOGEN TO FIBRIN.25,27,33 THIS ACTIVITY PERMITS THE FIBRIN CLOT TO INTEGRATE WITH THE FLOSEAL MATRIX PARTICLES THAT WILL FORM A FLOSEAL-FIBRIN MATRIX CLOT THAT HAS A TAMPONADING EFFECT ON THE BLEEDING VESSEL WALL.27 IN OUR CASE, FLOSEAL WAS ABLE TO SIGNIFICANTLY REDUCE AND TERMINATE THE BLEEDING WHEN ALL OTHER TOPICAL HEMOSTATIC MEASURES FAILED DUE TO ITS BIOLOGIC AND MECHANICAL PROPERTIES. WE RECOMMEND THAT FLOSEAL SHOULD BE CONSIDERED IN CASES WHERE INTRA- OPERATIVE AND POSTOPERATIVE BLEEDING BECOMES PROBLEMATIC. HOWEVER, THE SURGEON MUST BE AWARE OF THE LIMITATIONS OF ALL TOPICAL HEMOSTATIC AGENTS. LIKE OTHER TOPICAL HEMOSTATIC AGENTS, FLOSEAL WILL PROBABLY NOT STOP HIGH- PRESSURE TYPES OF BLEEDING. IN THESE INSTANCES, OTHER CONVENTIONAL SURGICAL MEANS SHOULD BE CONSIDERED. THIS CASE REPORT DETAILS AN UNEXPECTED, IN-OFFICE, INTRAOPERATIVE VASCULAR COMPLICATION IN THE ANTERIOR MANDIBLE DURING IMPLANT SURGERY THAT IS CONSIDERED APPROPRIATE AND THE STANDARD OF CARE. PREVIOUS REPORTS DEMONSTRATING LIFE-THREATENING HEMORRHAGE AND HEMATOMA FORMATION IN THE FLOOR OF THE MOUTH LEADING TO RESPIRATORY OBSTRUCTION HAVE BEEN REPORTED. IN MANY OF THESE CASES, A DRILLING DEPTH OF 15 MM DURING IMPLANT OSTEOTOMY PREPARATION WAS THE CAUSE OF ARTERIAL INJURY THROUGH MISANGULATION OF THE BUR THROUGH THE LINGUAL CORTICAL PLATE. THEREFORE, THE LENGTH OF IMPLANTS TO BE PLACED IN THE ANTERIOR MANDIBLE SHOULD BE CAREFULLY CONSIDERED. SEVERAL AUTHORS ARE OF THE OPINION THAT BICORTICAL STABILIZATION IN THE ANTERIOR MANDIBLE IS NO LONGER NECESSARY FOR IMPLANT SUCCESS, AND THE BENEFITS VERSUS THE RISKS OF PLACING IMPLANTS LONGER THAN 13 MM SHOULD BE CAREFULLY CONSIDERED. WE ARE IN AGREEMENT WITH THE AUTHORS, AS OUR CASE REPORT DEMONSTRATES THAT ATTEMPTING TO PLACE LONG IMPLANTS IN THE ANTERIOR MANDIBLE MAY VIOLATE THE NEUROVASCULAR CONTENTS WITHIN THE MANDIBULAR INCISIVE CANAL THAT COULD ALSO LEAD TO ARTERIAL BLEEDING. AMENDMENT: THE FOLLOW-UP IS TO UPDATE COMPANY CASE COMMENT. NO FOLLOW UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE REPORTED BRISK BLEEDING WAS CONSIDERED AS DUE TO DENTAL IMPLANTS, AND UNLIKELY CAUSALLY RELATED TO ITS TREATMENT/INTERVENTION WITH HEMOSTATS INCLUDING GELATIN AND THROMBIN. COMPANY CAUSALITY IS PROCESSED AS RELATED AS CONSERVATIVE APPROACH AND FOR REPORTING PURPOSE.
AS A FINAL MEASURE TO STOP THE BLEEDING, TOPICAL BOVINE THROMBIN (THROMBINE-JMI, PFIZER, NEW YORK, NY) WAS APPLIED TO ARREST THE HEMORRHAGING, BUT TO NO AVAIL [DRUG INEFFECTIVE]. CASE NARRATIVE: THIS LITERATURE REPORT IS BASED ON THE JOURNAL OF IMPLANT DENTISTRY (YEAR 2012) VOL 21 (5): (PGS. 368-373) ENTITLED "BRISK, PULSATILE BLEEDING FROM THE ANTERIOR MANDIBULAR INCISIVE CANAL DURING IMPLANT SURGERY: A CASE REPORT AND USE OF AN ACTIVE HEMOSTATIC MATRIX TO TERMINATE ACUTE BLEEDING." A (B)(6) ASIAN MAN WAS TREATMENT PLANNED FOR THE EXTRACTION OF THE 3 REMAINING MANDIBULAR ANTERIOR TEETH FOLLOWED BY IMMEDIATE IMPLANT PLACEMENT OF 4 DENTAL IMPLANTS TO SUPPORT A COMPLETE OVERDENTURE AND BAR. THE PATIENT'S MEDICAL HISTORY WAS UNREMARKABLE AND NEGATIVE FOR COAGULOPATHIES. HE WAS NOT PRESCRIBED ANY MEDICATIONS AND DENIED HAVING ANY ALLERGIES TO MEDICATION. BEFORE SURGERY, A FORMAL WORKUP WAS PERFORMED THAT INCLUDED IMAGING STUDIES CONSISTING OF A PANORAMIC RADIOGRAPH AND CONE BEAM COMPUTED TOMOGRAPHY (CBCT) WITH 3-DIMENSIONAL INTERACTIVE COMPUTER SOFTWARE TO EVALUATE THE ANTERIOR MANDIBLE FOR IMPLANT PLACEMENT IN THE INTER-FORAMINAL REGION. BASED ON THE IMAGING STUDIES, THERE WAS SATISFACTORY BONE VOLUME IN ALL 3 DIMENSIONS FOR IMPLANT PLACEMENT IN THE ANTERIOR MANDIBLE. A TREATMENT PLAN WAS FORMULATED WHERE FOUR 3.5 MM 3 15.0 MM IMPLANTS WOULD BE IMMEDIATELY PLACED IN THE INTERFORAMINAL REGION TO SUPPORT A COMPLETE MANDIBULAR OVERDENTURE AFTER THE TEETH WERE EXTRACTED, AND AN ALVEOLECTOMY WAS PERFORMED. USE OF LONG IMPLANTS AND BICORTICAL STABILIZATION ARE ACCEPTED STANDARDS OF CARE TO ACHIEVE PRIMARY IMPLANT STABILITY TO OBTAIN OSSEOINTEGRATION AND SUPPORT OVERDENTURES IN THE ANTERIOR MANDIBLE. SURGERY WAS PERFORMED UNDER LOCAL ANESTHESIA VIA BILATERAL MANDIBULAR NERVE BLOCKS AND SOFT TISSUE INFILTRATION INTO THE BUCCAL AND ANTERIOR LABIAL VESTIBULE OF THE MANDIBLE. AFTER A STANDARD MUCOPERIOSTEAL INCISION WAS MADE, THE SOFT TISSUE FLAP WAS DEVELOPED AND REFLECTED OFF OF THE MANDIBLE. THE TEETH WERE EXTRACTED (NUMBERS 22, 23, AND 27), AND AN ALVEOLOPLASTY PROCEDURE WAS PERFORMED TO REMOVE THE SHARP BONE SPICULES AND UNDERCUTS WITHOUT EVENT. PREPARATION AND DRILLING OF THE 4 IMPLANT OSTEOTOMY SITES (22, 24, 25, AND 27 AREAS) WERE FOLLOWED ACCORDING TO THE INSTRUCTIONS OF THE IMPLANT MANUFACTURER. WHILE PREPARING THE 4 IMPLANT OSTEOTOMY SITES USING TWIST DRILLS OF VARYING DIAMETER, A BRISK, PULSATILE BLEED WAS ENCOUNTERED FROM THE IMPLANT OSTEOTOMY SITE IN THE LEFT CANINE REGION. THE SOURCE OF THE BLEEDING WAS IMMEDIATELY IDENTIFIED AS COMING FROM WITHIN THE OSTEOTOMY SITE AND NOT THE FLOOR OF THE MANDIBULAR INCISIVE CANAL THAT COULD RESULT IN IATROGENIC BLEEDING. INITIAL HEMOSTATIC MEASURES WERE APPLIED TO THE OSTEOTOMY SITE, SUCH AS GAUZE DIGITAL PRESSURE TO TAMPONADE THE HEMORRHAGE, WHICH WAS PROVED UNSUCCESSFUL. USE OF VARIOUS HEMOSTATIC AGENTS, SUCH AS ABSORBABLE GELATIN SPONGES (GEL FOAM; PHARMACIA AND UPJOHN, CO, KALAMAZOO, MI), MICROFIBRILLAR COLLAGEN (AVITENE; CR BARD, INC, MURRAY HILL, NJ), AND OXIDIZED CELLULOSE, (SURGICEL; ETHICON, INC, SOMERVILLE, NJ), APPLIED TO THE BLEEDING OSTEOTOMY SITE FAILED TO STOP THE BLEEDING. THE BLEEDING WAS VERY BRISK, AS ATTEMPTS TO PLACE THE HEMOSTATIC AGENTS INTO THE OSTEOTOMY SITE WERE UNSUCCESSFUL, AS THEY WOULD IMMEDIATELY FLOW BACK UP AND OUT OF THE OSTEOTOMY SITE. AS A FINAL MEASURE TO STOP THE BLEEDING, TOPICAL BOVINE THROMBIN (THROMBINE-JMI, PFIZER, NEW YORK, NY) WAS APPLIED TO ARREST THE HEMORRHAGING BUT TO NO AVAIL. AS ALL LOCAL HEMOSTATIC MANEUVERS FAILED TO CONTROL THE BRISK, PULSATILE BLEEDING FROM THE IMPLANT SITE, AN IMPLANT WAS PLACED INTO THE OSTEOTOMY SITE, SIMILAR TO CAPPING OFF A SPOUTING OIL WELL. WITH THE IMPLANT PLACED INTO THE OSTEOTOMY SITE, THE BRISK, PULSATILE BLEEDING WAS OBSERVED TO HAVE FINALLY SLOWED FROM THE IMPLANT SITE. HOWEVER, INSPECTION OF THE ANTERIOR MANDIBLE REVEALED THAT THE BLEEDING HAD NOT BEEN TOTALLY ARRESTED BECAUSE SLOW BLEEDING WAS NOW OBSERVED FROM THE OTHER IMPLANT OSTEOTOMY SITES (23 AND 24 AREAS). DURING THE ENTIRE ACUTE HEMORRHAGIC EPISODE, THE PATIENT WAS CONSTANTLY MONITORED AND DID NOT DEMONSTRATE ANY CLINICAL SIGNS OF CARDIAC INSTABILITY AND RESPIRATORY DISTRESS, SUCH AS FLOOR OF MOUTH EDEMA OR TONGUE ELEVATION THAT COULD LEAD TO RESPIRATORY OBSTRUCTION. PATENCY OF THE PATIENT'S AIRWAY WAS ALWAYS A TOP PRIORITY. AS ALL LOCAL HEMOSTATIC MEASURES FAILED TO ARREST THE BLEEDING, THE DECISION WAS MADE TO TRANSPORT THE PATIENT ACCOMPANIED BY THE SURGEON (C.Y.S.L.) TO THE EMERGENCY DEPARTMENT (ED) OF A NEARBY HOSPITAL 10 MINUTES AWAY FROM THE OFFICE FOR CONTINUED TREATMENT OF THE PROFUSE ARTERIAL BLEEDING AND TO MANAGE ANY POTENTIAL MEDICAL COMPLICATIONS, SUCH AS FLUID VOLUME RESUSCITATION AND AIRWAY OBSTRUCTION. IN ADDITION, LABORATORY VALUES COULD BE OBTAINED TO MONITOR THE PATIENT'S HEMODYNAMIC CONDITION. ON ADMISSION TO THE ED, THE PATIENT PRESENTED WITH A BLOOD PRESSURE OF 205/102 MM HG AND A PULSE RATE OF 83 BEATS/MINUTE. HE DENIED HAVING A SIGNIFICANT MEDICAL HISTORY AND DENIED TAKING ANY MEDICATIONS. THE PATIENT HAD NO KNOWN ALLERGIES TO MEDICATION AND DENIED TOBACCO USE BUT ADMITTED TO OCCASIONAL ALCOHOL USE. THE PHYSICAL EXAMINATION WAS UNREMARKABLE. THE ABDOMEN WAS SOFT AND NON-DISTENDED. NO HEPATOSPLENOMEGALY WAS OBSERVED. THE CARDIOVASCULAR AND PULMONARY EXAMINATIONS WERE UNREMARKABLE. UNDER CONSTANT MONITORING IN THE ED, THE PATIENT DID NOT DEMONSTRATE ANY PROGRESSIVE SIGNS AND SYMPTOMS OF RESPIRATORY DISTRESS OR HYPOVOLEMIC COMPROMISE. HOWEVER, IF THE PATIENT DEMONSTRATED ANY EVIDENCE OF ACUTE RESPIRATORY DISTRESS, IT WAS DECIDED THAT THE PATIENT WOULD BE PROPHYLACTICALLY INTUBATED TO MAINTAIN THE AIRWAY. BASELINE LABORATORY VALUES IMMEDIATELY OBTAINED IN THE ED DEMONSTRATED A RED BLOOD CELL COUNT OF 5.01 (NORMAL RANGE, 4.7-6.1 MILLION CELLS/ML), WHITE BLOOD CELL COUNT OF 10.0 (NORMAL RANGE, 4500-10,000 CELLS/ ML), PLATELET COUNT OF 333,000/CUBIC MILLIMETER (NORMAL RANGE, 150,000- 400,000/MM3), HEMOGLOBIN LEVEL OF 15.0 G/DL (NORMAL RANGE, 13.8-17.2 G/DL), AND A HEMATOCRIT LEVEL OF 44.3% (NORMAL RANGE, 40.7%-50.3%). THE PRO-THROMBIN TIME WAS 12.6 SECONDS (NORMAL RANGE, 10-12 SECONDS); PARTIAL THROMBO-PLASTIN TIME WAS 31 SECONDS (NORMAL RANGE, 30-45 SECONDS), AND INTERNATIONAL NORMALIZED RATIO VALUE WAS 0.97 (NORMAL RANGE, 1-2). IN CONSULTATION WITH THE ED PHYSICIANS, USE OF WHOLE BLOOD, FRESH FROZEN PLASMA, PACKED RED BLOOD CELLS, AND PLATELETS WOULD ALL BE CONSIDERED TO MAINTAIN THE PATIENT'S HEMOSTATIC VOLUME. AS LIGATION OF THE BLEEDING VESSEL IS THE PREFERRED TREATMENT TO TERMINATE BLEEDING, THIS IS OFTEN TIMES IMPOSSIBLE DUE TO THE LOCATION OF THE VESSEL AND SURGICAL ACCESS. SURGICAL MEASURES CONSIDERED TO OBTAIN DEFINITIVE CONTROL OF THE BLEEDING VESSEL INCLUDED EXPLORATORY SURGERY WITH SELECTIVE LIGATION OF THE BRANCHES OF THE EXTERNAL CAROTID ARTERY AND ARTERIAL EMBOLIZATION VIA INTERVENTIONAL ANGIOGRAPHY. HOWEVER, AS THE AUTHORS WERE FAMILIAR WITH THE HEMOSTATIC AGENT FLOSEAL, THE DECISION WAS MADE TO APPLY THIS BIOACTIVE HEMOSTATIC AGENT TO THE OSTEOTOMY SITE IN THE ED BEFORE CONSIDERING TRANSFUSION OF BLOOD PRODUCTS AND SURGICAL INTERVENTION. WITH THE REMOVAL OF THE IMPLANT FROM THE OSTEOTOMY SITE, RESUMPTION OF BRISK, PULSATILE BLEEDING WAS OBSERVED. CONSTANT OOZING OF BLOOD WAS ALSO OBSERVED FROM THE OTHER OSTEOTOMY SITES WHEN THE GAUZE PACKS WERE REMOVED. DIRECT ACCESS TO THE INTRAOSSEOUS BLEEDING VESSEL WAS NOT POSSIBLE. FLOSEAL WAS PREPARED ACCORDING TO THE INSTRUCTIONS OF THE MANUFACTURER AND APPLIED TO THE IMPLANT OSTEOTOMY SITE WITH FIRM GAUZE PRESSURE. THROMBIN, 2500 INTERNATIONAL UNITS, WAS RECONSTITUTED IN STERILE SALINE AND MIXED WITH THE COLLAGEN MATRIX. WITHIN 10 MINUTES AFTER THE APPLICATION OF FLOSEAL GEL TO THE OSTEOTOMY SITE WITH FIRM DIGITAL PRESSURE, BLEEDING MARKEDLY SLOWED. THE ACTIVE HEMOSTATIC AGENT WAS THEN APPLIED TO THE OTHER OSTEOTOMY SITES FOLLOWED BY FIRM GAUZE PRESSURE. AFTER 1 HOUR OF CONTINUED OBSERVATION, THE PROFUSE BLEEDING WAS ONLY OOZING FROM THE IMPLANT OSTEOTOMY SITES THEN. AFTER 4 HOURS OF FURTHER OBSERVATION IN THE ED, THE PATIENT WAS DISCHARGED TO HOME IN STABLE CONDITION. THROUGHOUT THE ENTIRE COURSE, THE PATIENT'S VITAL SIGNS REMAINED STABLE. IT WAS ESTIMATED THAT PATIENT'S BLOOD LOSS WAS APPROXIMATELY 300 ML. APPROXIMATELY 1 LITER OF CRYSTALLOID WAS TRANSFUSED TO THE PATIENT. THE PATIENT RETURNED TO THE OFFICE IN 1 WEEK FOR OBSERVATION OF THE SURGICAL SITE. HE REPORTED ONLY SPORADIC OOZING OF BLOOD FROM THE OSTEOTOMY SITES WHILE RECOVERING OVER THE NEXT 24 HOURS AT HOME. POSTOPERATIVE EDEMA AND ECCHYMOSIS PROVED TO BE THE MAIN CONCERN TO THE PATIENT RATHER THAN THE BLEEDING EPISODE. POSTOPERATIVE IMAGING STUDIES CONSISTING OF CBCT SCANS OF THE MANDIBLE WERE OBTAINED TO EVALUATE THE POSSIBLE CAUSE OF THE INTRAOPERATIVE BLEEDING. USING 3-DIMENSIONAL INTERACTIVE COMPUTER SOFTWARE (SIMPLANT, GLEN BURNIE, MD), DENTAL IMPLANT SURGERY USING TWIST DRILLS WAS SIMULATED AND IMPLANTS OF 15.0 MM IN LENGTH COULD VIOLATE THE NEUROVASCULAR STRUCTURES IN THE ANTERIOR MANDIBULAR INCISIVE CANAL. IT CAN BE OBSERVED THAT VIRTUAL IMPLANT PLACEMENT OF ALL 4 IMPLANTS WOULD ENCOUNTER THE NEUROVASCULAR BUNDLE OF THE MANDIBULAR INCISIVE CANAL THAT COULD LEAD TO IATROGENIC PROFUSE BLEEDING. DENTAL IMPLANT SURGERY IN THE ANTERIOR MANDIBLE IS A COMMON SURGICAL PROCEDURE THAT IS CONSIDERED RELATIVELY SAFE AND FREE OF COMPLICATIONS. WE BELIEVE THAT LACERATION OF THE VASCULAR STRUCTURES IN THE MANDIBULAR INCISIVE CANAL DURING THE IMPLANT OSTEOTOMY PROCEDURE WHILE USING A LONG TWIST DRILL WAS THE CAUSE FOR THE ACUTE PROFUSE HEMORRHAGE ENCOUNTERED INTRAOPERATIVELY. THIS CASE REPORT IS UNIQUE BECAUSE THE TREATMENT PLAN WAS TO PLACE 4 IMPLANTS OF 15.0 MM IN LENGTH INTO THE ANTERIOR MANDIBLE TO ACHIEVE PRIMARY IMPLANT STABILITY. TREATMENT USING LONG DENTAL IMPLANTS IN THE ANTERIOR MANDIBLE TO STABILIZE A MANDIBULAR OVERDENTURE IS CONSIDERED A SAFE AND ACCEPTABLE PROCEDURE, AS WELL AS OBTAINING BICORTICAL STABILIZATION. KNOWLEDGE OF SURGICAL ANATOMY IS CRITICAL, AS DIFFERENT IN-OFFICE SURGICAL PROCEDURES ARE ROUTINELY PERFORMED IN THE ANTERIOR MANDIBLE, SUCH AS DENTAL IMPLANT SURGERY, EXTRACTION OF TEETH, HARVESTING BONE FROM THE SYMPHYSIS OF THE CHIN, TORI REMOVAL, AND TRAUMA SURGERY TO REPAIR FRACTURES OF THE MANDIBLE. ALL OF THESE SURGICAL PROCEDURES MAY ACCIDENTLY RESULT IN SEVERE BLEEDING FROM THE MANDIBULAR INCISIVE CANAL. IF NOT EMERGENTLY MANAGED, THIS COMPLICATION MAY ESCALATE TO A SITUATION OF SIGNIFICANT BLOOD LOSS, OR PROGRESS TO A LIFE-THREATENING DISSECTING HEMATOMA IN THE FLOOR OF THE MOUTH THAT COULD LEAD TO RESPIRATORY OBSTRUCTION. THE CLINICIAN PERFORMING SURGERY IN THIS ANATOMICAL REGION MUST BE PREPARED TO MANAGE SUCH COMPLICATIONS. SEVERAL AUTHORS HAVE INVESTIGATED THE VASCULAR ANATOMY OF THE ANTERIOR MANDIBLE AND HEAD AND NECK REGION BY CADAVER DISSECTION, COMPUTED TOMOGRAPHY, AND ULTRASOUND. IN 1928, OLIVIER FIRST DESCRIBED THE MANDIBULAR INCISIVE NERVE AS A CONTINUATION OF THE INFERIOR ALVEOLAR NERVE FROM THE POSTERIOR MANDIBLE. OTHER AUTHORS HAVE DEFINED THE NEUROANATOMICAL STRUCTURES IN THIS LOCATION BY DIVIDING THE INFERIOR ALVEOLAR NERVE INTO BRANCHES OF THE MENTAL AND MANDIBULAR INCISIVE NERVE. THEY FURTHER DESCRIBED THE SUBLINGUAL AND SUBMENTAL ARTERIES AS ANASTOMOSING BRANCHES FROM THE EXTERNAL CAROTID ARTERY THAT ENTER THE MIDLINE OF THE ANTERIOR MANDIBLE VIA THE LINGUAL FORAMEN. STUDIES BY VANDEWALLE ET AL AND LIANG ET AL DESCRIBED THE NEUROVASCULAR ANATOMY OF THE ANTERIOR MANDIBLE AND FLOOR OF THE MOUTH. BOTH AUTHORS WERE IN AGREEMENT OF THE POTENTIAL INTRAOPERATIVE RISK OF NEUROVASCULAR INJURY WHILE PLACING DENTAL IMPLANTS IN THE ANTERIOR MANDIBLE DUE TO THE CLOSE PROXIMITY OF THESE ANATOMICAL STRUCTURES. IN A CADAVER STUDY BY ROSANO ET AL, THEY EVALUATED 60 DRY MANDIBLES AND RECOMMENDED AGAINST THE USE OF SURGICALLY PLACING LONG IMPLANTS TO AVOID THE RISK OF SURGICAL TRAUMA TO THE LINGUAL CORTICAL PLATE THAT COULD LEAD TO SEVERE BLEEDING IN THE FLOOR OF THE MOUTH. MAKRIS ET AL, USING CBCT SCANS OBTAINED FROM 100 PATIENTS, EVALUATED THE VISIBILITY OF THE INCISIVE CANAL AND LINGUAL FORAMEN. THE INCISIVE CANAL WAS VISIBLE IN 83.5% OF THE SCANS. THE MEAN END POINT WAS APPROXIMATELY 15 MM ANTERIOR TO THE MENTAL FORAMEN. THE MEAN DISTANCE FROM THE INFERIOR BORDER OF THE MANDIBLE WAS 11.5 MM. THE LINGUAL FORAMEN WAS VISIBLE IN 81% OF THE SCANS. THE RESULTS OF THIS STUDY DEMONSTRATE THE POTENTIAL RISK OF IATROGENIC INJURY TO THE VASCULAR STRUCTURES IN THE ANTERIOR MANDIBLE DURING IMPLANT PREPARATION THAT COULD LEAD TO HEMORRHAGIC EPISODES. PROFUSE, PULSATILE, AND BRISK BLEEDING FROM DENTAL IMPLANT SURGERY IN THE ANTERIOR MANDIBLE IS UNCOMMON. ALTHOUGH OUR CASE DID NOT PROGRESS TO A LIFE-THREATENING SITUATION, INTRAOPERATIVE BLEEDING CAN BECOME SUBSTANTIAL AND PROGRESS TO A LIFE-THREATENING SITUATION. IT HAS BEEN ESTIMATED THAT 400 ML OF BLOOD COULD BE DRAINED FROM A BLOOD VESSEL WITH AN INTRAVASCULAR DIAMETER OF 1 TO 2 MM IN 30 MINUTES. BLEEDING THAT IS DIFFICULT TO CONTROL OR INEFFECTIVE IS ALWAYS A CHALLENGE TO THE SURGEON. THE SURGEON MUST REMAIN COMPOSED AND CALM TO ARREST THE BLEEDING. PROMPT RECOGNITION AND MANAGEMENT OF THE SOURCE OF BLEEDING WITH ANY SURGICAL PROCEDURE IS CRITICAL TO AVOID PROGRESSION TO SEVERE LIFE-THREATENING COMPLICATIONS. HEMOSTATIC STRATEGIES KNOWLEDGE IN THE MECHANISM OF HEMOSTASIS IS CRITICAL IN THE OVERALL OUTCOME OF THE SURGICAL PATIENT. HEMOSTASIS CONSISTS OF A SERIES OF COORDINATED, COMPLEX REACTIONS IN THE COAGULATION CASCADE THAT INVOLVES THE PLATELETS AND BLOOD VESSEL WALL. WHEN INTRAOPERATIVE BLEEDING IS ENCOUNTERED, THE SURGEON HAS SEVERAL OPTIONS TO TERMINATE THE BLEEDING. THESE INCLUDE MECHANICAL AND THERMAL METHODS, TO THE USE OF PHARMACOLOGIC AND TOPICAL AGENTS. ATTEMPTS TO CONTROL INTRAOPERATIVE BLEEDING ARE DEPENDENT ON MANY VARIABLES, BUT INITIALLY, THEY RELY ON DIRECT PRESSURE OR COMPRESSION WITH GAUZE PACKING AT THE BLEEDING SITE. MECHANICAL METHODS CONSIST OF THE USE OF SUTURES TO LIGATE THE SOURCE OF BLEEDING, STAPLES, AND LIGATING CLIPS. HOWEVER, THESE TECHNIQUES CAN BE APPLIED IF THE SOURCE OF BLEEDING IS IDENTIFIED AND VISUALIZED. THERMAL TECHNIQUES USING LASERS AND ELECTROCAUTERY ARE OPTIONS AVAILABLE TO THE SURGEON BUT MAY BE UNAVAILABLE IN THE OFFICE SETTING. MECHANICAL AND THERMAL TECHNIQUES MAY NOT ALWAYS BE ABLE TO EFFECTIVELY CONTROL THE SOURCE OF BLEEDING, SUCH AS IN BONY STRUCTURES, INFLAMED SOFT TISSUES, AND DIFFUSE BLEEDING CAPILLARIES. IN THESE INSTANCES, THE USE OF PHARMACOLOGIC AGENTS MIGHT BE MORE APPROPRIATE. THESE AGENTS ARE USED TO ENHANCE THE COAGULATION CASCADE OF THE PATIENT AND INCLUDE INJECTION OF LOCAL ANESTHETIC THAT CONTAINS EPINEPHRINE, TISSUE ADHESIVES, AND TOPICAL HEMOSTATS. IN THE OFFICE SETTING, THE SURGEON SHOULD HAVE SEVERAL DIFFERENT TYPES OF HEMOSTATIC PRODUCTS AVAILABLE TO CONTROL AND ARREST BLEEDING. TOPICAL HEMOSTATS ARE DIVIDED INTO 2 CATEGORIES: PASSIVE AND ACTIVE. PASSIVE ABSORBABLE HEMOSTATS ARE USED TO APPLY DIRECT PRESSURE TO TAMPONADE THE HEMORRHAGE AND INCLUDE COLLAGEN SPONGES, GELATINS, AND CELLULOSE. BIOLOGICALLY ACTIVE TOPICAL HEMOSTATS ARE THROMBIN AND COMBINATION PRODUCTS THAT CONTAIN THROMBIN, SUCH AS FLOSEAL. IN OUR CASE, ATTEMPTS TO CONTROL THE PROFUSE, BRISK, PULSATILE BLEEDING IN THE OFFICE WITH VARIOUS TOPICAL HEMOSTATIC MEASURES PROVED UNSUCCESSFUL. LIGATION OF A BLEEDING VESSEL IS THE TREATMENT OF CHOICE, BUT IT IS OFTEN DIFFICULT OR IMPOSSIBLE DUE TO SURGICAL ACCESS AND ANATOMY. THIS PROVED TO BE THE SITUATION IN OUR PATIENT. THEREFORE, ONCE IN THE ED, THE DECISION WAS MADE TO USE AN ACTIVE BIOACTIVE HEMOSTAT, SUCH AS FLOSEAL. ALTHOUGH FLOSEAL IS NOT AVAILABLE FOR IN-OFFICE USE, CLINICIANS WHO PERFORM SURGERY SHOULD BE AWARE OF THIS HEMOSTATIC PRODUCT TO CONTROL BLEEDING THAT RANGES FROM OOZING TO ARTERIAL SPURTING. THIS UNIQUE CHARACTERISTIC OF TISSUE EXPANSION IN THE AREA OF BLEEDING IS THE PRIMARY MECHANISM FOR TERMINATING THE SOURCE OF BLEEDING. DURING THIS PROCESS, THROMBIN ACTS ON THE PATIENT'S COAGULATION CASCADE BY CONVERTING FIBRINOGEN TO FIBRIN. THIS ACTIVITY PERMITS THE FIBRIN CLOT TO INTEGRATE WITH THE FLOSEAL MATRIX PARTICLES THAT WILL FORM A FLOSEAL-FIBRIN MATRIX CLOT THAT HAS A TAMPONADING EFFECT ON THE BLEEDING VESSEL WALL. IN OUR CASE, FLOSEAL WAS ABLE TO SIGNIFICANTLY REDUCE AND TERMINATE THE BLEEDING WHEN ALL OTHER TOPICAL HEMOSTATIC MEASURES FAILED DUE TO ITS BIOLOGIC AND MECHANICAL PROPERTIES. WE RECOMMEND THAT FLOSEAL SHOULD BE CONSIDERED IN CASES WHERE INTRAOPERATIVE AND POSTOPERATIVE BLEEDING BECOMES PROBLEMATIC. HOWEVER, THE SURGEON MUST BE AWARE OF THE LIMITATIONS OF ALL TOPICAL HEMOSTATIC AGENTS. LIKE OTHER TOPICAL HEMOSTATIC AGENTS, FLOSEAL WILL PROBABLY NOT STOP HIGH-PRESSURE TYPES OF BLEEDING. IN THESE INSTANCES, OTHER CONVENTIONAL SURGICAL MEANS SHOULD BE CONSIDERED. THIS CASE REPORT DETAILS AN UNEXPECTED, IN-OFFICE, INTRAOPERATIVE VASCULAR COMPLICATION IN THE ANTERIOR MANDIBLE DURING IMPLANT SURGERY THAT IS CONSIDERED APPROPRIATE AND THE STANDARD OF CARE. PREVIOUS REPORTS DEMONSTRATING LIFE-THREATENING HEMORRHAGE AND HEMATOMA FORMATION IN THE FLOOR OF THE MOUTH LEADING TO RESPIRATORY OBSTRUCTION HAVE BEEN REPORTED. IN MANY OF THESE CASES, A DRILLING DEPTH OF 15 MM DURING IMPLANT OSTEOTOMY PREPARATION WAS THE CAUSE OF ARTERIAL INJURY THROUGH MISANGULATION OF THE BUR THROUGH THE LINGUAL CORTICAL PLATE. THEREFORE, THE LENGTH OF IMPLANTS TO BE PLACED IN THE ANTERIOR MANDIBLE SHOULD BE CAREFULLY CONSIDERED. SEVERAL AUTHORS ARE OF THE OPINION THAT BICORTICAL STABILIZATION IN THE ANTERIOR MANDIBLE IS NO LONGER NECESSARY FOR IMPLANT SUCCESS, AND THE BENEFITS VERSUS THE RISKS OF PLACING IMPLANTS LONGER THAN 13 MM SHOULD BE CAREFULLY CONSIDERED. WE ARE IN AGREEMENT WITH THE AUTHORS, AS OUR CASE REPORT DEMONSTRATES THAT ATTEMPTING TO PLACE LONG IMPLANTS IN THE ANTERIOR MANDIBLE MAY VIOLATE THE NEUROVASCULAR CONTENTS WITHIN THE MANDIBULAR INCISIVE CANAL THAT COULD ALSO LEAD TO ARTERIAL BLEEDING. NO FOLLOW UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE REPORTED BRISK BLEEDING WAS CONSIDERED AS DUE TO DENTAL IMPLANTS, AND NOT CAUSALLY RELATED TO ITS TREATMENT/INTERVENTION WITH HEMOSTATS INCLUDING GELATIN AND THROMBIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149628 | GELFOAM | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. (DEVICE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male | Hospitalization| R |