ZEVO¿ ANTERIOR CERVICAL PLATE SYSTEM
Report
- Report Number
- 1030489-2021-00675
- Event Type
- Injury
- Date Received
- May 21, 2021
- Report Date
- July 8, 2022
- Manufacturer
- WARSAW ORTHOPEDICS
- Product Code
- KWQ
- PMA / PMN Number
- K141632
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- 003
Narratives
PRODUCT ID# 3003045, LOT# 0662191W IT APPEARS THE LOCKING MECHANISM OF THE PLATE DISLODGE BECAUSE OF THE BONE SCREW NOT BEING INSTALLED ON AXIS WITH THE HOLE IN THE PLATE. SINCE THE LOCKING MECHANISM WAS NOT RETURNED IT IS NOT KNOWN IF THE SCREW WAS FLUSH WITH THE TOP OF THE PLATE AT THE TIME OF INSTALLATION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
D2: UPDATED :COMMON DEVICE NAME: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
HISTORY OF ABDOMINAL SURGERY, HISTORY OF ABDOMINOPLASTY, HISTORY OF BACK SURGERY, HISTORY OF KNEE REPLACEMENT, HISTORY OF KNEE RIGHT SURGERY ON (B)(6) 2019: FINDING: TECHNICALLY LIMITED EXAM WITH ONLY TRANSABDOMINAL IMAGING PERFORMED AND NEARLY EMPTY BLADDER AT START OF EXAM, STILL NOT AD EQUATELY DISTENDED EVEN FOLLOWING DRINKING 4 GLASS OF WATER AND RESCANNING 15 MINUTES LATER. IMPRESSION: LIMITED/ SUBOPTIMAL EXAM DUE TO LACK OF ENDOVAGINAL IMAGING AND INADEQUATE FILLING OF URINARY BLADDER. 1. NORMAL -SIZED UTERUS WITH ENDOMETRIAL STRIPE UNABLE TO BE MEASURED. 2. NONIDENTIFIED OVARIES. 3. NO FREE FLUID. ON (B)(6) 2019: FINDING: CAD REVIEWED. NO MASSES, SUSPICIOUS CALCIFICATION OR OTHER SIGNS OF MALIGNANCY ARE IDENTIFIED. THERE HAS BEEN NO SIGNIFICANT CHANGE IN THE APPEARANCE OF EITHER BREAST. IMPRESSION: NEGATIVE MAMMOGRAM. ON (B)(6) 2019: PATIENT HAD CT SCAN. FINDING: SPINE: REVERSAL NORMAL CERVICAL LORDOSIS CENTERED AT THE C4-5 LEVEL. TRACE RETROLISTHESIS C4 ON C5. ADVANCE DISC HEIGHT LOSS C4-5 THROUGH C6-7, MILD BONY FORAMINALNARROWING C4-5 THROUGH C5-6. NO EVIDENCE OF ACUTE BONY INJURY INVOLVING THE CERVICAL SPINE. SOFT TISSUE: ATHEROSCLEROTIC CALCIFICATION OF THE CAROTID ARTERIES. ATHEROSCLEROTIC CALCIFICATION OF THE AORTIC ARCH. IMPRESSION: NO EVIDENCE OF ACUTE BONY INJURY INVOLVING THE CERVICAL SPINE.
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (PATIENT, MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WITH STENOSIS DEGENERATIVE DISC DISEASE FOR ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SPINAL THERAPY AT C3-C6. IT WAS REPORTED THAT THE ZEVO LOCKING MECHANISM DETACHED FROM THE PLATE, ALLOWING THE SCREWS TO BACK OUT. THE LEVEL OF THE AREA WITH THE DETACHED LOCKING MECHANISM NEVER FUSED AND A REVISION SURGERY WAS NECESSARY. THERE WAS NECK PAIN AND ARM PAIN PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. (B)(6) 2022, EMAIL: ADDITIONAL INFORMATION RECEIVED STATES THAT IMPLANT DATE(S): (B)(6) 2020 PATIENT DEMOGRAPHICS: GENDER- FEMALE, INITIALS (B)(6)AGE ¿ 75, DOB - (B)(6) 1945, WEIGHT ¿ 164 LBS IT WAS REPORTED THAT: ON (B)(6) 2020: PATIENT CAME FOR FOLLOW UP VISIT FOR LEG PAIN THAT SHE HAD BEEN GOING ON SINCE ABOUT 2013. THE PAIN WAS LOCATED INTO BOTH THE LEGS INTO THE POSTERIOR THIGHS TO THE LEVEL OF THE KNEES. SHE DEVELOPED SOME BLADDER ISSUE AND HAD DIFFICULTY MAKING IT TO THE BATHROOM. MRI DEMONSTRATE WORSENING STENOSIS L3-L5 NOW SEVER. SHE HAS A SCOLIOTIC CURVE FROM L1 DOWN TO S1. SHE HAS A GRADE 1 SLIP AT L3-4 AND L4-5. SURGEON DISCUSSED THAT ONE COULD CONSIDER A LONG SEGMENT SURGERY L1-S1 BUT WOULD FAVOR A MORE FOCAL APPROACH WITH A L3-5 LAMINECTOMY, LEFT SIDED L34, L45 TLIF AND L3-L5 POSTERIOR FUSION. AFTER CAREFUL CONSIDERATION, PATIENT ELECTED TO PROCEED WITH L3-5 LAMINECTOMY, LEFT SIDED L34, L45 TLIF AND L3-L5 POSTERIOR FUSION DONE BY SURGEON ON (B)(6) 2017. RTC AFTER UNDERGOING A NEW MRI. HER FACIAL PARALYSIS HAS RESOLVED. SHE HAS WORSENING LOW BACK PAIN AND PAIN INTO HER RIGHT ANTERIOR HIGH. RETURNS WITH NEW SYMPTOMS. SHE IS DOING WELL IN REGARDS WITH HER LUMBAR SPINE FOLLOWING HER MOST RECENT RIGHT L2-3 ESI WITH SURGEON ON (B)(6) 2019 WHICH HAS OFFERED HER 100% RELIEF. 3 WEEKS AGO, SHE BEGAN TO HAVE ELECTRIC SHOCH THAT GO INTO BOTH ARM AND THROUGH OUT HER TORSO. THE SHOCKS ARE WORSE WHEN SHE TILTS HER HEAD BACK. SHE HAS PAIN IN BOTH THE ARM. SHE UNDERWENT A X-RAY WITH A CHIROPRACTOR WHO THEN RECOMMENDED SHE COME SEE US FOR A CERVICAL EVALUATION. RTC WITH CERVICAL AND THORACIC MRI FOR REVIEW. SHE HAS BEEN PLACED ON GABAPENTIN SINCE THE LAST VISIT WHICH HAS RESOLVED HER NECK AND UE SYMPTOMS. SHE STILL DENIES WEAKNESS BALANCE CONCERNS OR DROPPING OBJECTS. RADIOLOGY IMPRESSION; MRI SPINE WO (B)(6) 2020 IMPRESSION: 1. MULTILEVEL DEGENERATIVE DISC DISEASE FACET ARTHROSIS. 2. SEVERE SPINAL CANAL STENOSIS AT C4-C5 AND C5-C6. MILD TO MODERATE SPINAL CANAL STENOSIS OTHERWISE FROM C2 THROUGH C7. 3. SEVERE MULTILEVEL FORAMINAL STENOSIS. 4. NO ABNORMAL CERVICAL CORD SIGNAL TO SUGGEST MYOMALACIA. MRI THORACIC WO (B)(6) 2020: IMPRESSION: 1. STABLE MILD OLD COMPRESSION FRACTURE SUPERIOR END PLATE T8. 2. MILD DISC BULGE AT T2-3, VERY MILD DISC BULGE AT T7-8 AND TINY RIGHT CENTRAL DISC PROTRUSION AT T6-7 WITHOUT CENTRAL CANAL STENOSIS OR SPINAL CORD COMPRESSION. 3. MILD RIGHT T2-3 FORAMINAL NARROWING. 4. SMALL SYRINX IN THE DISTAL THORACIC CORD. ON (B)(6) 2020: PATIENT ORIGINALLY PRESENTED WITH LEFT LEG PAIN HAD BEEN GOING ON SINCE ABOUT 2013. THE PAIN WAS LOCATED INTO BOTH LEGS INTO THE POSTERIOR THIGHS TO THE LEVEL OF THE KNEES. LEFT > RIGHT. AFTER CAREFUL CONSIDERATION, PATIENT ELECTED TO PROCEED WITH L3-5 LAMINECTOMY, LEFT SIDED L34 AND L45 TLIF AND POSTERIOR FUSION DONE BY DR RAJPAL ON (B)(6) 2017. RETURNED IN (B)(6) 2019 WHEN SHE BEGAN TO HAVE "ELECTRICAL SHOCKS" THAT GO INTO BOTH ARMS AND THROUGHOUT HER TORSO. THE SHOCKS ARE WORSE WHEN SHE TILTS HER HEAD BACK. SHE HAS PAIN IN BOTH ARMS. DENIES ANY WEAKNESS IN HER EXTREMITIES OR DIFFICULTIES WITH HER BALANCE/GAIT. SHE UNDERWENT A CERVICAL AND THORACIC MRI AND WAS FOUND TO HAVE SEVERE STENOSIS IN HER CERVICAL SPINE. SHE ALSO HAS ADJACENT SEGMENT STENOSIS IN HER LUMBAR SPINE AND WOULD LIKE TO PROCEED WITH LUMBAR SURGERY WHEN ABLE. SHE UNDERWENT A RIGHT L2-3 ESI WITH DR CHAVDA ON (B)(6) 2019 WHICH OFFERED HER 100% RELIEF. SHE HAS ELECTED TO PROCEED WITH ACDF C3-6. PRESENTS TODAY FOR A PRE SURGERY VISIT. SHE HAS OBTAINED MEDICAL CLEARANCE AND IS NOT TAKING ANY BLOOD THINNING MEDICATION. SHE WOULD LIKE TO DISCUSS HER LUMBAR SURGERY TIMING ONCE SHE IS RECOVERED FROM HER CERVICAL SURGERY. HER LAST MRI LUMBAR WAS IN (B)(6) 2019. IMPRESSION: 1. MULTILEVEL DEGENERATIVE DISC DISEASE FACET ARTHROSIS. 2. SEVERE SPINAL CANAL STENOSIS AT C4-C5 AND C5-C6. MILD TO MODERATE SPINAL CANAL STENOSIS OTHERWISE FROM C2 THROUGH C7. 3. SEVERE MULTILEVEL FORAMINAL STENOSIS. 4. NO ABNORMAL CERVICAL CORD SIGNAL TO SUGGEST MYOMALACIA. MRI THORACIC WO (B)(6) 2020 IMPRESSION: 1. STABLE MILD OLD COMPRESSION FRACTURE SUPERIOR ENDPLATE T8. 2. MILD DISC BULGE AT T2-3, VERY MILD DISC BULGE AT T7-8, AND TINY RIGHT CENTRAL DISC PROTRUSION AT T6-7 WITHOUT CENTRAL CANAL STENOSIS OR SPINAL CORD COMPRESSION. ON (B)(6) 2020: SURGICAL PROCEDURE AS 1. ANTERIOR ARTHRODESIS WITH APPROACH TO C3, C4, C5, AND C6. 2. C3-C4 DISKECTOMY WITH BILATERAL FORAMINOTOMIES, OSTEOPHYTECTOMIES AND INTERBODY FUSION USING A 7 MM TITANIUM-COATED PEEK CAGE FILLED WITH MORSELIZED AUTOGRAFT AND ALLOGRAFT. 3. C4-C5 DISKECTOMY WITH BILATERAL FORAMINOTOMIES, OSTEOPHYTECTOMIES AND INTERBODY FUSION USING A 7 MM TITANIUM-COATED PEEK CAGE FILLED WITH MORCELLIZED AUTOGRAFT AND ALLOGRAFT. 4. C5-C6 DISKECTOMY WITH BILATERAL FORAMINOTOMIES, OSTEOPHYTECTOMIES AND INTERBODY FUSION USING 6 MM TITANIUM-COATED PEEK CAGE FILLED WITH MORSELIZED AUTOGRAFT AND ALLOGRAFT. 5. ANTERIOR CERVICAL FUSION C3, C4, C5, AND C6 WITH A 45 MM MEDTRONIC ZEVO PLATE. 6. USE OF INTRAOPERATIVE FLUOROSCOPY, LESS THAN 1 HOUR PHYSICIAN TIME. 7. USE OF NEUROMONITORING. 8. USE OF OPERATING MICROSCOPE. THE PATIENT NEEDS LUMBAR SURGERY. IMAGING DEMONSTRATED SEVERE SPINAL STENOSIS C4 THROUGH C6 AND CERVICAL KYPHOSIS AND SPONDYLOLISTHESIS, C3-C4. THE PATIENT WAS BROUGHT TO THE OPERATING THEATER AND UNDERWENT GENERAL ENDOTRACHEAL ANESTHESIA WITHOUT COMPLICATIONS. SHE HAD VENODYNES, TED HOSE AND THE APPROPRIATE LINES PLACED BY ANESTHESIA. HER HEAD WAS MAINTAINED SUPINE ON THE OPERATING ROOM TABLE WITH HER HEAD IN SLIGHT EXTENSION. ALL BONY PROMINENCES WERE INSPECTED AND PADDED. USING LATERAL FLUOROSCOPY AND SPINAL NEEDLE, WE PICKED OUR ENTRY POINT TO THE C3 THROUGH C6 LEVELS. THIS MARKED A TRANSVERSE INCISION ON THE RIGHT SIDE OF HER NECK. THIS AREA WAS PREPPED AND DRAPED IN THE USUAL STERILE SURGICAL FASHION. TIMEOUT WAS COMPLETED PER PROTOCOL. THE PATIENT RECEIVED ANTIBIOTICS WITHIN ONE HOUR OF INCISION. THE INCISION WAS TAKEN DOWN THROUGH THE SCALPEL BLADE. USING MONOPOLAR, THE INCISION WAS TAKEN DOWN THE TISSUES TO THE SUBCUTANEOUS TISSUES TO THE LEVEL OF THE PLATYSMA. THE PLATYSMA WAS OVERMINED IN THE CRANIAL AND CAUDAL DIRECTIONS. A WEITLANER WAS PLACED TO MAINTAIN OUR EXPOSURE. SURGEON OPENED THE FIBERS OF THE PLATYSMA CRANIALLY AND CAUDALLY. USING BOTH BLUNT AND SHARP DISSECTION, SURGEON THEN TRAVELED IN A PLANE MEDIAL TO THE CAROTID SHEATH, LATERAL TO THE ESOPHAGUS AND TRACHEA TO REACH PREV ERTEBRAL FASCIA. A BAYONETTED NEEDLE WAS PLACED INTO C4-C5 AND WE CONFIRMED OUR LEVEL USING LATERAL FLUOROSCOPY. SURGEON ELEVATED THE LONGUS COLLI MUSCLE FROM THE ANTERIOR VERTEBRAL BODIES OF C3, C4, C5, AND C6. DEEP RETRACTORS WERE PLACED TO MAINTAIN OUR EXPOSURE. THE MICROSCOPE WAS BROUGHT INTO THE FIELD TO ASSIST WITH MICROSCOPIC DISSECTION AND TO MAINTAIN ILLUMINATION AND MAGNIFICATION. SURGEON PLACED CASPAR PINS INTO C3 AND C4 AND PLACED C3 AND C4 INTO MILD DISTRACTION. SURGEON COMPLETED A C3-C4 DISKECTOMY WITH BILATERAL FORAMINOTOMIES AND OSTEOPHYTECTOMIES. SURGEON PREPARED THE CARTILAGINOUS ENDPLATES AND MEASURED INTERBODY SPACE. WE PLACED A 7 MM TITANIUM-COATED PEEK CAGE FILLED WITH MORCELLIZED AUTOGRAFT AND ALLOGRAFT INTO THE C3-C4 DISK SPACE. SURGEON THEN MOVE THE CASPAR PIN FROM C3 AND PLACED IT INTO C5 AND PLACED C4-C5 INTO MILD DISTRACTION. SURGEON COMPLETED THE C4-C5 DISKECTOMY WITH BILATERAL FORAMINOTOMIES AND OSTEOPHYTECTOMIES. SURGEON PREPARED THE CARTILAGINOUS ENDPLATES AND MEASURED INTERBODY SPACE. WE PLACED A 7 MM TITANIUM-COATED PEEK CAGE FILLED WITH MORSELIZED AUTOGRAFT AND ALLOGRAFT INTO THE C4-C5 DISK SPACE. SURGEON REMOVED THE CASPAR PIN FROM C4 AND PLACED IT INTO C6 AND PLACED C5-C6 INTO MILD DISTRACTION. SURGEON COMPLETED A C5-C6 DISKECTOMY WITH BILATERAL FORAMINOTOMIES AND OSTEOPHYTECTOMIES. SURGEON PREPARED THE CARTILAGINOUS ENDPLATES AND MEASURED INTERBODY SPACE. WE PLACED 6 MM TITANIUM-COATED PEEK CAGE FILLED WITH MORSELIZED AUTOGRAFT AND ALLOGRAFT INTO THE C5-C6 DISK SPACE. SURGEON REMOVED THE CASPAR PINS, DRILLED DOWN THE ANTERIOR OSTEOPHYTES AND SECURED A 45 MM MEDTRONIC ZEVO PLATE ONTO THE VERTEBRAL BODIES OF C3, C4, C5 AND C6. AP AND LATERAL X-RAYS DEMONSTRATED GOOD PLACEMENT OF THE HARDWARE. THE WOUND WAS IRRIGATED COPIOUSLY WITH BACITRACIN IRRIGATION. WE OBTAINED HEMOSTASIS WITH THE BIPOLAR. THE WOUND WAS THEN CLOSED IN MULTIPLE LAYERS USING VICRYL SUTURES FOR THE DEEP LAYERS AND DERMABOND FOR THE SKIN. THE PATIENT'S WOUND WAS DRESSED STERILELY. SHE WAS AWAKENED, EXTUBATED, AND TAKEN TO RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO COMPLICATIONS AND NO NOTED CHANGES ON NEUROMONITORING THROUGHOUT THE PROCEDURE. PATIENT REPORTING VERY LITTLE PAIN AND NO ISSUES WITH SWALLOWING NOTED. FLUOROSCOPY WAS PROVIDED FOR PERFORMANCE OF PROCEDURE. IMAGES DEMONSTRATE INTRAOPERATIVE VIEWS WITH SURGICAL INSTRUMENTS AND FIXATION HARDWARE OVER THE ANTERIOR CERVICAL SPINE. FLUOROSCOPY TIME: 11.1 SECONDS. CUMULATIVE DOSE: 0.94 MGY. FLUOROSCOPY UTILIZED FOR ANTERIOR CERVICAL SPINE INSTRUMENTATION. X-RAY OF 2 VIEW CERVICAL SPINE SERIES. FINDINGS: ANTERIOR FUSION C3-C6. THERE IS OUTWARD MIGRATION OF THE SCREWS AT C6 WHICH EXTEND UP TO 7 MM AWAY FROM THE PLATE. OTHER HARDWARE IS STABLE IN POSITION. ALIGNMENT IS UNCHANGED. IMPRESSION: INTERVAL LOOSENING/MIGRATION OF C6 SCREWS. ON (B)(6) 2020: PATIENT ORIGINALLY PRESENTED WITH LEFT LEG PAIN HAD BEEN GOING ON SINCE ABOUT 2013. THE PAIN WAS LOCATED INTO BOTH LEGS INTO THE POSTERIOR THIGHS TO THE LEVEL OF THE KNEES. LEFT > RIGHT. AFTER CAREFUL CONSIDERATION, PATIENT ELECTED TO PROCEED WITH L3-5 LAMINECTOMY, LEFT SIDED L34 AND L45 TLIF AND POSTERIOR FUSION DONE BY DR RAJPAL ON (B)(6) 2017. RETURNED IN (B)(6) 2019 WHEN SHE BEGAN TO HAVE "ELECTRICAL SHOCKS" THAT GO INTO BOTH ARMS AND THROUGHOUT HER TORSO. THE SHOCKS ARE WORSE WHEN SHE TILTS HER HEAD BACK. SHE HAS PAIN IN BOTH ARMS. DENIES ANY WEAKNESS IN HER EXTREMITIES OR DIFFICULTIES WITH HER BALANCE/GAIT. SHE UNDERWENT A CERVICAL AND THORACIC MRI AND WAS FOUND TO HAVE SEVERE STENOSIS IN HER CERVICAL SPINE. SHE ALSO HAS ADJACENT SEGMENT STENOSIS IN HER LUMBAR SPINE AND WOULD LIKE TO PROCEED WITH LUMBAR SURGERY WHEN ABLE. SHE UNDERWENT A RIGHT L2-3 ESI WITH DR CHAVDA ON (B)(6) 2019 WHICH OFFERED HER 100% RELIEF. SHE ULTIMATELY UNDERWENT A C3/4/5/6 ACDF WITH DR RAJPAL ON (B)(6) 2020. RTC 2 WEEKS POST OP. SHE HAS NO NECK PAIN OR UE RADICULAR PAIN OR WEAKNESS. SHE HAS BEEN COMPLIANT WITH HER COLLAR. SHE STATES THAT HER PCP HAS ENCOURAGED HER TO DECREASE HER GABAPENTIN WHICH HAS MADE HER BACK PAIN WORSE. SHE WOULD LIKE TO PROCEED WITH LUMBAR SURGERY AS SOON AS POSSIBLE. SHE DENIES ANY CONCERNS WITH HER INCISION. NO FEVER/CHILLS/DRAINAGE. (B)(6) 2020: MRI CERVICAL SPINE WAS PERFORMED: FINDINGS: TWO VIEWS OF THE CERVICAL SPINE ARE OBTAINED. ANTERIOR PLATE AND SCREW DEVICE EXTENDS FROM C3 TO C6. INTERVERTEBRAL BONE GRAFT IS NOTED AT THE C3-4, C4-5 AND C5-6 DISC SPACES. ALIGNMENT IS GROSSLY ANATOMIC. MODERATE PREVERTEBRAL SOFT TISSUE SWELLING IDENTIFIED. UNDERLYING DIFFUSE CERVICAL SPONDYLOSIS. NO FOCAL LYTIC OR SCLEROTIC LESIONS. IMPRESSION: C3-C6 FUSION. 02-AUGUST-2019: AXIAL CT THROUGH THE LUMBAR SPINE WITHOUT CONTRAST. CORONAL AND SAGITTAL REFORMATTED IMAGES WERE MADE FROM THE AXIAL DATA SET. THIS EXAMINATION WAS PERFORMED USING AUTOMATED EXPOSURE CONTROL, ADJUSTMENT OF MA OR KV ACCORDING TO PATIENT SIZE, AND/OR USE OF ITERATIVE RECONSTRUCTION TECHNIQUE. FINDINGS: THERE ARE 3 MM ANTEROLISTHESES OF L3 ON L4 AND L4 ON L5. THERE IS STRAIGHTENING OF THE LUMBAR LORDOSIS. THERE IS A 22 DEGREE DEXTROS COLIOSIS CENTERED AT THE LEVEL OF L3-4 AND THERE IS ABOUT 5 MM OF RIGHT LATERAL L4 ON L5 LISTHESIS. BILATERAL PEDICLE SCREWS HAVE BEEN PLACED AT L3, L4, AND L5 AND ARE BRIDGED BY VERTICALLY ORIENTED CONNECTING RODS. THE HARDWARE IS IN GOOD POSITION, INTACT, AND THERE IS NO EVIDENCE OF HARDWARE LOOSENING. INTERVERTEBRAL DISC GRAFTS AT L3-4 AND L4-5 APPEAR RELATIVELY WELL INCORPORATED. POSTERIOR DECOMPRESSION HAS BEEN PERFORMED AT L4-5 AND L5 S1. LATERAL MASS BONE GRAFT ALSO APPEARS TO HAVE BEEN PLACED ON THE RIGHT SIDE, AND THERE COULD BE LESS WELL INCORPORATED LATERAL MASS BONE GRAFTING ON THE LEFT SIDE AS WELL. THE L3-4 AND L4-5 FACET JOINTS ARE FUSED ON THE RIGHT SIDE. THE LEFT-SIDED FACET JOINTS AT THESE LEVELS ARE MORE DIFFICULT TO ASSESS. L1-2: MILD DISC SPACE NARROWING WITH ANTERIOR PREDOMINANT VERTEBRAL BODY OSTEOPHYTE FORMATION. PROBABLE RIGHT LATERAL AND INTRAFORAMINAL DISC PROTRUSION. MODERATE BILATERAL FACET ARTHROPATHY. NO HIGH-GRADE SPINAL CANAL STENOSIS ON AN OSSEOUS BASIS. L2-3: CONSIDERABLE DISC SPACE NARROWING WITH VACUUM DISC PHENOMENON AND EXTENSIVE SCLEROSIS OF THE L2 AND L3 VERTEBRAL BODIES, PROGRESSED IN THE INTERVAL. PROBABLE RIGHT INTRAFORAMINAL DISC PROTRUSION. THERE IS ANTERIOR AND LATERAL PREDOMINANT VERTEBRAL BODY OSTEOPHYTE FORMATION. THERE IS ADVANCED BILATERAL FACET ARTHROPATHY WITH APPARENT THICKENING OF THE LIGAMENTUM FLAVUM, MORE SIGNIFICANTLY ON THE LEFT. NO HIGH-GRADE SPINAL CANAL STENOSIS ON AN OSSEOUS BASIS. THERE APPEARS TO BE FAIRLY SIGNIFICANT LEFT LATERAL RECESS STENOSIS. L3-4: THE SPINAL CANAL IS DIFFICULT TO ASSESS DUE TO ARTIFACT EMANATING FROM THE FUSION HARDWARE AND DISC GRAFT. NO EVIDENCE OF HIGH-GRADE SPINAL CANAL STENOSIS ON AN OSSEOUS B ASIS. L4-5: THE SPINAL CANAL IS DIFFICULT TO ASSESS DUE TO ARTIFACT EMANATING FROM THE FUSION HARDWARE AND DISC PROSTHESIS. NO EVIDENCE OF HIGH-GRADE SPINAL CANAL STENOSIS ON AN OSSEOUS BASIS. L5-S1: SMALL TO MODERATE BROAD-BASED POSTERIOR AND LATERAL DISC BULGE. NO HIGH-GRADE SPINAL CANAL STENOSIS. ADVANCED FACET ARTHROPATHY. IMPRESSION: 1. STATUS POST ANTERIOR AND POSTERIOR FUSION L3-L5. 2. NO FINDING TO INDICATE INTERVAL DEVELOPMENT OF SIGNIFICANT SPINAL CANAL STENOSIS. 3. PROGRESSIVE DISCOGENIC SPONDYLOSIS L2-3. 4. LUMBAR DEXTROSCOLIOSIS WITH GRADE 1 L3 ON L4 AND L4 ON L5 ANTEROLISTHESIS. 5. PROBABLE RIGHT-SIDED INTRAFORAMINAL DISC PROTRUSIONS AT L1-2 AND L2-3. (B)(6) 2020: MULTIPLANAR MULTI SEQUENTIAL IMAGING OF THE LUMBAR SPINE OBTAINED WITHOUT IV GADOLINIUM. FINDINGS: ALIGNMENT: 3 MM RETROLISTHESIS L2 ON L3. PREVIOUS L3-L5 POSTERIOR AND INTERBODY FUSION. STRAIGHTENING OF LORDOSIS. DEXTROCONVEX LUMBAR CURVATURE. MARROW SIGNAL: TYPE I DISCOGENIC MARROW CHANGE AT L2-3. SPINAL CORD: NO CORD SIGNAL ABNORMALITY. THE CONUS TERMINATES AT L1. INTERVERTEBRAL DISCS: SEVERE DISC HEIGHT LOSS AT L2-3. MILD DISC HEIGHT LOSS AT L1-2. AXIAL IMAGES DEMONSTRATE THE FOLLOWING: T12-L1: MILD DISC BULGE. SPINAL CANAL AND FORAMINA ARE PATENT. L1-L2: DIFFUSE DISC BULGE WITH SUPERIMPOSED RIGHT FORAMINAL AND EXTRAFORAMINAL ZONE BROAD-BASED PROTRUSION. MODERATE BILATERAL FACET ARTHROSIS AND LIGAMENTUM FLAVUM OVERGROWTH. THERE IS MODERATE RIGHT FORAMINAL STENOSIS. LEFT FORAMEN IS PATENT. SPINAL CANAL IS PATENT. DISC MATERIAL ABUTS THE EXITING RIGHT L1 NERVE. L2-L3: DIFFUSE DISC BULGE ECCENTRIC TO THE LEFT. THERE IS A SUPERIMPOSED LEFT SUBARTICULAR AND PROXIMAL FORAMINAL ZONE CEPHALAD DIRECTED DISC EXTRUSION. CONCOMITANT ADVANCED LEFT-SIDED FACET ARTHROSIS WITH SYNOVIAL HYPERTROPHY. SEVERE NARROWING OF THE LEFT SUBARTICULAR RECESS WITH DISPLACEMENT OF THE DESCENDING LEFT L3 NERVE ROOT. THERE IS MILD SPINAL CANAL STENOSIS AND SEVERE LEFT FORAMINAL STENOSIS. RIGHT FORAMEN IS PATENT. L3-L4: FUSION LEVEL. SPINAL CANAL AND FORAMINA ARE PATENT. L4-L5: FUSION LEVEL. SPINAL CANAL IS PATENT. THE FORAMINA ARE PATENT. L5-S1: SHALLOW BROAD-BASED CENTRAL DISC PROTRUSION. MODERATE BILATERAL FACET ARTHROSIS. SPINAL CANAL IS PATENT. MODERATE RIGHT FORAMINAL STENOSIS. LEFT FORAMEN IS PATENT. IMPRESSION: 1. L3-L5 POSTERIOR AND INTERBODY FUSION. 2. ADJACENT SEGMENT DEGENERATION AT L2-3. THERE IS A LEFT SUBARTICULAR ZONE CEPHALAD DIRECTED EXTRUSION AND ASYMMETRIC LEFT-SIDED FACET ARTHROSIS RESULTING IN SEVERE NARROWING OF THE LEFT FORAMEN AND SEVERE NARROWING OF THE LEFT SUBARTICULAR RECESS WITH POSSIBLE IMPINGEMENT ON THE EXITING LEFT L2 NERVE AND THE DESCENDING LEFT L3 NERVE ROOT. X-RAY FOR 2 VIEW CERVICAL SPINE SERIES. FINDINGS: ANTERIOR FUSION PLATE AND SCREWS ARE PRESENT FROM C3 THROUGH C6, ALONG WITH WELL-POSITIONED INTERBODY GRAFTS. THE C6 SCREWS PROTRUDE APPROXIMATELY 6 MM ANTERIORLY FROM THE PLATE, SIMILAR TO THE PRIOR RADIOGRAPHS. DEGENERATIVE DISC DISEASE IS SEVERE AT C6-7 AND MULTILEVEL FACET ARTHROPATHY IS PRESENT. ALIGNMENT IS NORMAL AND NO FRACTURE OR BONY LESION IS DEMONSTRATED. CT LUMBAR SPINE WO CONTRAST (B)(6) 2020: 1. STATUS POST ANTERIOR AND POSTERIOR FUSION L3-5. 2. NO FINDING TO INDICATE INTERVAL DEVELOPMENT OF SIGNIFICANT SPINAL CANAL STENOSIS. 3. 3. PROGRESSIVE DISCOGENIC SPONDYLOSIS L2-3. 4. LUMBAR DEXTROSCOLIOSIS WITH GRADE 1 L3 ON L4 ON L5 ANTEROLISTHESIS. 5. PROBABLE RIGHT-SIDED INTRAFORAMINAL DISC PROTRUSION AT L1-2 AND L2-3. AVISTA XR CERVICAL SPINE 2 OR 3 VIEW (B)(6) 2020 INTERVAL LOOSENING/MIGRATION OF C6 SCREW. RADIOLOGY IMPRESSIONS XRAY C 2 3 VIEW (B)(6) 2020 IMPRESSION: 1. UNCHANGED 6 MM ANTERIOR PROTRUSION OF THE BASES OF THE C6 SCREWS FROM THE UNDERLYING PLATE, SIMILAR TO (B)(6)2020. 2. REMAINING HARDWARE APPEARS WELL SEATED AND INTACT. 3. UNCHANGED SEVERE DEGENERATIVE DISC DISEASE AT C6-7 AND MULTILEVEL FACET ARTHROPATHY. IMPRESSION: 1. UNCHANGED 6 MM ANTERIOR PROTRUSION OF THE BASES OF THE C6 SCREWS FROM THE UNDERLYING PLATE, SIMILAR TO (B)(6)2020. 2. REMAINING HARDWARE APPEARS WELL SEATED AND INTACT. 3. UNCHANGED SEVERE DEGENERATIVE DISC DISEASE AT C6-7 AND MULTILEVEL FACET ARTHROPATHY.
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (PATIENT, MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WITH STENOSIS DEGENERATIVE DISC DISEASE FOR ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SPINAL THERAPY AT C3-C6. IT WAS REPORTED THAT THE ZEVO LOCKING MECHANISM DETACHED FROM THE PLATE, ALLOWING THE SCREWS TO BACK OUT. THE LEVEL OF THE AREA WITH THE DETACHED LOCKING MECHANISM NEVER FUSED AND A REVISION SURGERY WAS NECESSARY. THERE WAS NECK PAIN AND ARM PAIN PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED STATES THAT IMPLANT DATE(S): (B)(6) 2020 PATIENT DEMOGRAPHICS: GENDER- FEMALE, INITIALS (B)(6) AGE ¿ 75, DOB - (B)(6) 1945, WEIGHT ¿ 164 LBS ON (B)(6) 2020: PATIENT CAME FOR FOLLOW UP VISIT FOR LEG PAIN THAT SHE HAD BEEN GOING ON SINCE ABOUT 2013. THE PAIN WAS LOCATED INTO BOTH THE LEGS INTO THE POSTERIOR THIGHS TO THE LEVEL OF THE KNEES. SHE DEVELOPED SOME BLADDER ISSUE AND HAD DIFFICULTY MAKING IT TO THE BATHROOM. MRI DEMONSTRATE WORSENING STENOSIS L3-L5 NOW SEVER. SHE HAS A SCOLIOTIC CURVE FROM L1 DOWN TO S1. SHE HAS A GRADE 1 SLIP AT L3-4 AND L4-5. SURGEON DISCUSSED THAT ONE COULD CONSIDER A LONG SEGMENT SURGERY L1-S1 BUT WOULD FAVOR A MORE FOCAL APPROACH WITH A L3-5 LAMINECTOMY, LEFT SIDED L34, L45 TLIF AND L3-L5 POSTERIOR FUSION. AFTER CAREFUL CONSIDERATION, PATIENT ELECTED TO PROCEED WITH L3-5 LAMINECTOMY, LEFT SIDED L34, L45 TLIF AND L3-L5 POSTERIOR FUSION DONE BY SURGEON ON (B)(6) 2017. RTC AFTER UNDERGOING A NEW MRI. HER FACIAL PARALYSIS HAS RESOLVED. SHE HAS WORSENING LOW BACK PAIN AND PAIN INTO HER RIGHT ANTERIOR HIGH. RETURNS WITH NEW SYMPTOMS. SHE IS DOING WELL IN REGARDS WITH HER LUMBAR SPINE FOLLOWING HER MOST RECENT RIGHT L2-3 ESI WITH SURGEON ON (B)(6) 2019 WHICH HAS OFFERED HER 100% RELIEF. 3 WEEKS AGO, SHE BEGAN TO HAVE ELECTRIC SHOCH THAT GO INTO BOTH ARM AND THROUGH OUT HER TORSO. THE SHOCKS ARE WORSE WHEN SHE TILTS HER HEAD BACK. SHE HAS PAIN IN BOTH THE ARM. SHE UNDERWENT A X-RAY WITH A CHIROPRACTOR WHO THEN RECOMMENDED SHE COME SEE US FOR A CERVICAL EVALUATION. RTC WITH CERVICAL AND THORACIC MRI FOR REVIEW. SHE HAS BEEN PLACED ON GABAPENTIN SINCE THE LAST VISIT WHICH HAS RESOLVED HER NECK AND UE SYMPTOMS. SHE STILL DENIES WEAKNESS BALANCE CONCERNS OR DROPPING OBJECTS. ON (B)(6) 2020: SURGICAL PROCEDURE AS 1. ANTERIOR ARTHRODESIS WITH APPROACH TO C3, C4, C5, AND C6. 2. C3-C4 DISKECTOMY WITH BILATERAL FORAMINOTOMIES, OSTEOPHYTECTOMIES AND INTERBODY FUSION USING A 7 MM TITANIUM-COATED PEEK CAGE FILLED WITH MORSELIZED AUTOGRAFT AND ALLOGRAFT. 3. C4-C5 DISKECTOMY WITH BILATERAL FORAMINOTOMIES, OSTEOPHYTECTOMIES AND INTERBODY FUSION USING A 7 MM TITANIUM-COATED PEEK CAGE FILLED WITH MORCELLIZED AUTOGRAFT AND ALLOGRAFT. 4. C5-C6 DISKECTOMY WITH BILATERAL FORAMINOTOMIES, OSTEOPHYTECTOMIES AND INTERBODY FUSION USING 6 MM TITANIUM-COATED PEEK CAGE FILLED WITH MORSELIZED AUTOGRAFT AND ALLOGRAFT. 5. ANTERIOR CERVICAL FUSION C3, C4, C5, AND C6 WITH A 45 MM MEDTRONIC ZEVO PLATE. 6. USE OF INTRAOPERATIVE FLUOROSCOPY, LESS THAN 1 HOUR PHYSICIAN TIME. 7. USE OF NEUROMONITORING. 8. USE OF OPERATING MICROSCOPE. THE PATIENT NEEDS LUMBAR SURGERY. IMAGING DEMONSTRATED SEVERE SPINAL STENOSIS C4 THROUGH C6 AND CERVICAL KYPHOSIS AND SPONDYLOLISTHESIS, C3-C4. THE PATIENT WAS BROUGHT TO THE OPERATING THEATER AND UNDERWENT GENERAL ENDOTRACHEAL ANESTHESIA WITHOUT COMPLICATIONS. SHE HAD VENODYNES, TED HOSE AND THE APPROPRIATE LINES PLACED BY ANESTHESIA. HER HEAD WAS MAINTAINED SUPINE ON THE OPERATING ROOM TABLE WITH HER HEAD IN SLIGHT EXTENSION. ALL BONY PROMINENCES WERE INSPECTED AND PADDED. USING LATERAL FLUOROSCOPY AND SPINAL NEEDLE, WE PICKED OUR ENTRY POINT TO THE C3 THROUGH C6 LEVELS. THIS MARKED A TRANSVERSE INCISION ON THE RIGHT SIDE OF HER NECK. THIS AREA WAS PREPPED AND DRAPED IN THE USUAL STERILE SURGICAL FASHION. TIMEOUT WAS COMPLETED PER PROTOCOL. THE PATIENT RECEIVED ANTIBIOTICS WITHIN ONE HOUR OF INCISION. THE INCISION WAS TAKEN DOWN THROUGH THE SCALPEL BLADE. USING MONOPOLAR, THE INCISION WAS TAKEN DOWN THE TISSUES TO THE SUBCUTANEOUS TISSUES TO THE LEVEL OF THE PLATYSMA. THE PLATYSMA WAS OVERMINED IN THE CRANIAL AND CAUDAL DIRECTIONS. A WEITLANER WAS PLACED TO MAINTAIN OUR EXPOSURE. SURGEON OPENED THE FIBERS OF THE PLATYSMA CRANIALLY AND CAUDALLY. USING BOTH BLUNT AND SHARP DISSECTION, SURGEON THEN TRAVELED IN A PLANE MEDIAL TO THE CAROTID SHEATH, LATERAL TO THE ESOPHAGUS AND TRACHEA TO REACH PREV ERTEBRAL FASCIA. A BAYONETTED NEEDLE WAS PLACED INTO C4-C5 AND WE CONFIRMED OUR LEVEL USING LATERAL FLUOROSCOPY. SURGEON ELEVATED THE LONGUS COLLI MUSCLE FROM THE ANTERIOR VERTEBRAL BODIES OF C3, C4, C5, AND C6. DEEP RETRACTORS WERE PLACED TO MAINTAIN OUR EXPOSURE. THE MICROSCOPE WAS BROUGHT INTO THE FIELD TO ASSIST WITH MICROSCOPIC DISSECTION AND TO MAINTAIN ILLUMINATION AND MAGNIFICATION. SURGEON PLACED CASPAR PINS INTO C3 AND C4 AND PLACED C3 AND C4 INTO MILD DISTRACTION. SURGEON COMPLETED A C3-C4 DISKECTOMY WITH BILATERAL FORAMINOTOMIES AND OSTEOPHYTECTOMIES. SURGEON PREPARED THE CARTILAGINOUS ENDPLATES AND MEASURED INTERBODY SPACE. WE PLACED A 7 MM TITANIUM-COATED PEEK CAGE FILLED WITH MORCELLIZED AUTOGRAFT AND ALLOGRAFT INTO THE C3-C4 DISK SPACE. SURGEON THEN MOVE THE CASPAR PIN FROM C3 AND PLACED IT INTO C5 AND PLACED C4-C5 INTO MILD DISTRACTION. SURGEON COMPLETED THE C4-C5 DISKECTOMY WITH BILATERAL FORAMINOTOMIES AND OSTEOPHYTECTOMIES. SURGEON PREPARED THE CARTILAGINOUS ENDPLATES AND MEASURED INTERBODY SPACE. WE PLACED A 7 MM TITANIUM-COATED PEEK CAGE FILLED WITH MORSELIZED AUTOGRAFT AND ALLOGRAFT INTO THE C4-C5 DISK SPACE. SURGEON REMOVED THE CASPAR PIN FROM C4 AND PLACED IT INTO C6 AND PLACED C5-C6 INTO MILD DISTRACTION. SURGEON COMPLETED A C5-C6 DISKECTOMY WITH BILATERAL FORAMINOTOMIES AND OSTEOPHYTECTOMIES. SURGEON PREPARED THE CARTILAGINOUS ENDPLATES AND MEASURED INTERBODY SPACE. WE PLACED 6 MM TITANIUM-COATED PEEK CAGE FILLED WITH MORSELIZED AUTOGRAFT AND ALLOGRAFT INTO THE C5-C6 DISK SPACE. SURGEON REMOVED THE CASPAR PINS, DRILLED DOWN THE ANTERIOR OSTEOPHYTES AND SECURED A 45 MM MEDTRONIC ZEVO PLATE ONTO THE VERTEBRAL BODIES OF C3, C4, C5 AND C6. AP AND LATERAL X-RAYS DEMONSTRATED GOOD PLACEMENT OF THE HARDWARE. THE WOUND WAS IRRIGATED COPIOUSLY WITH BACITRACIN IRRIGATION. WE OBTAINED HEMOSTASIS WITH THE BIPOLAR. THE WOUND WAS THEN CLOSED IN MULTIPLE LAYERS USING VICRYL SUTURES FOR THE DEEP LAYERS AND DERMABOND FOR THE SKIN. THE PATIENT'S WOUND WAS DRESSED STERILELY. SHE WAS AWAKENED, EXTUBATED, AND TAKEN TO RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO COMPLICATIONS AND NO NOTED CHANGES ON NEUROMONITORING THROUGHOUT THE PROCEDURE. PATIENT REPORTING VERY LITTLE PAIN AND NO ISSUES WITH SWALLOWING NOTED. FLUOROSCOPY WAS PROVIDED FOR PERFORMANCE OF PROCEDURE. IMAGES DEMONSTRATE INTRAOPERATIVE VIEWS WITH SURGICAL INSTRUMENTS AND FIXATION HARDWARE OVER THE ANTERIOR CERVICAL SPINE. FLUOROSCOPY TIME: 11.1 SECONDS. CUMULATIVE DOSE: 0.94 MGY. FLUOROSCOPY UTILIZED FOR ANTERIOR CERVICAL SPINE INSTRUMENTATION. (B)(6) 2020: SURGEON PERFORMED POSTERIOR ARTHRODESIS WITH APPROACH TO L1, L2, L3, L4 AND L5. EXPLORATION AND REMOVAL OF PRIOR LUMBAR HARDWARE INCLUDING BILATERAL RODS FROM THE L3-L5 LEVELS AND THE BILATERAL PEDICLE SCREW REMOVAL FROM THE MEDTRONIC SOLERA 4.75 SYSTEM. PLACEMENT OF NEW BILATERAL PEDICLE SCREWS IN L1 AND L2 FROM THE MEDTRONIC 4.75 SOLERA SYSTEM. DECOMPRESSIVE LAMINECTOMY L2-L3 WITH LEFT-SIDED FACETECTOMY, DISCECTOMY AND INTERBODY FUSION USING 8 X 26 MM TITANIUM-COATED PEEK CAGE FILLED WITH MORSELIZED AUTOGRAFT AND ALLOGRAFT. LEFT-SIDED L1-L2 HEMILAMINOTOMY, FACETECTOMY, DISCECTOMY AND INTERBODY FUSION USING A 7 X 26 MM TITANIUM-COATED PEEK CAGE FILLED WITH MORSELIZED AUTOGRAFT AND ALLOGRAFT. POSTEROLATERAL FUSION ON THE RIGHT, L1-L3 WITH MORSELIZED AUTOGRAFT AND ALLOGRAFT. USE OF INTRAOPERATIVE 3D STEALTH NAVIGATION INCLUDING THE MAZOR X STEALTH EDITION ROBOT WITH GREATER THAN 25 MINUTES PLANNING AND EXECUTION TIME. USE OF INTRAOPERATIVE FLUOROSCOPY. USE OF NEUROMONITORING. USE OF THE OPERATIVE MICROSCOPE. INJECTION OF PRESERVATIVE-FREE INTRATHECAL NARCOTICS. INDICATIONS: PATIENT HAS UNDERGONE A PRIOR LUMBAR FUSION FROM WHICH SHE DID QUITE WELL. SHE PRESENTED WITH WORSENING LOWER EXTREMITY CLAUDICATION, RADICULOPATHY AND BACK PAIN. SHE HAD EVIDENCE OF SCOLIOSIS WITH WORSENING SPINAL STENOSIS ABOVE HER PRIOR FUSION AT THE L2-L3 LEVEL AND SPONDYLOSIS AT L1-L2. DESCRIPTION OF PROCEDURE: THE PATIENT WAS BROUGHT TO OPERATING THEATER AND UNDERWENT GENERAL ENDOTRACHEAL ANESTHESIA WITHOUT COMPLICATION. SHE HAD VENODYNES, TED HOSE AND THE APPROPRIATE LINES PLACED BY ANESTHESIA. SHE WAS FLIPPED PRONE ONTO THE JACKSON TABLE AND ALL BONY PROMINENCES INSPECTED AND PADDED. THE LOWER LUMBAR REGION WAS PREPPED AND DRAPED IN THE USUAL STERILE SURGICAL FASHION. A TIMEOUT WAS COMPLETED PER PROTOCOL AND THE PATIENT RECEIVED ANTIBIOTICS WITHIN ONE HOUR OF INCISION. THE PRIOR INCISION WAS INFILTRATED WITH MARCAINE WITH EPINEPHRINE AND TAKEN MORE CRANIALLY. THE INCISION WAS THEN TAKEN DOWN THROUGH SUBCUTANEOUS TISSUES TO THE LEVEL OF THE SPINOUS PROCESS OF L1. SURGEON COMPLETED A SUBPERIOSTEAL DISSECTION CARRIED OUT TO THE TRANSVERSE PROCESSES OF L1, L2, AND L3, AND IDENTIFIED THE PRIOR HARDWARE AT L3, L4, L5. DEEP RETRACTORS WERE PLACED TO MAINTAIN OUR EXPOSURE. SURGEON SEQUENTIALLY REMOVED THE BILATERAL CAP SCREWS FROM THEL3, L4, L5 LEVELS AS WELL AS BILATERAL RODS. SURGEON THEN REMOVED THE BILATERAL L5 RODS FROM MEDTRONIC SOLERA 4.75 SYSTEM. SURGEON ATTACHED A SMALL SCHANZ PIN INTO THE LEFT POSTERIOR SUPERIOR ILIAC SPINE. SURGEON ATTACHED THE MAZOR X STEALTH EDITION ROBOT TO THE LEFT SIDED SCHANZ PIN. SURGEON COMPLETED 3D STEALTH NAVIGATION SPIN. USING 3D STEALTH NAVIGATION, SURGEON THEN PLANNED AND DRILLED PILOT HOLES FOR THE BILATERAL PEDICLE SCREWS AT L1-L2. ALL HOLES WERE MANUALLY PALPATED WITH NO SIGNIFICANT CORTICAL BREACHES. SURGEON THEN TAPPED AND PLACED 5.5 X 45 MM SCREWS BILATERALLY AT L1 WITH 6.5 X 45 MM SCREWS BILATERALLY IN L2 FROM MEDTRONIC SOLERA 4.75 SYSTEM. ANOTHER 3D STEALTH NAVIGATION SPIN DEMONSTRATED GOOD P LACEMENT OF THE HARDWARE. AT THIS POINT, THE MICROSCOPE WAS BROUGHT INTO THE FIELD TO ASSIST WITH MICROSCOPIC DISSECTION AND TO MAINTAIN ILLUMINATION AND MAGNIFICATION. USING A COMBINATION OF THE BUR TIP ON THE DRILL BIT, KERRISON PUNCHES AND LEKSELL RONGEUR, SURGEON COMPLETED DECOMPRESSIVE LAMINECTOMY AT L2-L3 WITH LEFT-SIDED FACETECTOMY. SURGEON DISTRACTED DISC SPACE AND COMPLETED LEFT-SIDED L2-L3 DISCECTOMY. SURGEON PREPARED THE CARTILAGINOUS ENDPLATES AND MEASURED INTERBODY SPACE. SURGEON PLACED 8 X 26 MM TITANIUM-COATED PEEK CAGE FILLED WITH MORSELIZED AUTOGRAFT AND ALLOGRAFT ANTERIORLY AND TOWARDS THE MIDLINE. SURGEON PACKED ADDITIONAL MORSELIZED AUTOGRAFT IN THE DISC SPACE FOR THE INTERBODY FUSION. SURGEON LET DOWN THE DISTRACTION, MOVED UP TO THE L1-L2 LEVEL WHERE SURGEON COMPLETED LEFT-SIDED L1-L2 FACETECTOMY AND DISCECTOMY. WE PREPARED THE CARTILAGINOUS ENDPLATES AND MEASURED INTERBODY SPACE. SURGEON PLACED A 7 X 26 MM TITANIUM-COATED PEEK CAGE FILLED WITH MORSELIZED AUTOGRAFT AND ALLOGRAFT ANTERIORLY AND TOWARDS THE MIDLINE. SURGEON PACKED ADDITIONAL MORSELIZED AUTOGRAFT IN THE DISC SPACE FOR THE INTERBODY FUSION. SURGEON LET DOWN DISTRACTION AND DECORTICATED THE BONE ON THE RIGHT SIDE BETWEEN L1 AND L3. SURGEON PLACED TWO LORDOTIC RODS INTO THE HEADS OF THE SCREWS BETWEEN L1 AND L4 AND SECURED THEM DOWN WITH CAP SCREWS, WHICH WERE TIGHTENED PER MANUFACTURER'S SETTING. SURGEON INJECTED PRESERVATIVE-FREE INTRATHECAL NARCOTICS. THE WOUND WAS IRRIGATED COPIOUSLY WITH BACITRACIN IRRIGATION. SURGEON PLACED MORSELIZED AUTOGRAFT AND ALLOGRAFT ON THE RIGHT SIDE BETWEEN L1 AND L3 FOR POSTEROLATERAL FUSION. WE LEFT THE DRAIN IN SUBFASCIAL SPACE AND CLOSED THE WOUND IN MULTIPLE LAYERS USING VICRYL SUTURES FOR THE DEEP LAYERS AND DERMABOND FOR THE SKIN. THE PATIENT'S WOUND WAS DRESSED STERILELY. SHE WAS FLIPPED SUPINE ONTO THE TRANSFER CART WHERE SHE WAS AWAKENED, EXTUBATED, AND TAKEN TO RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO COMPLICATIONS AND NO NOTED CHANGES ON NEUROMONITORING THROUGHOUT THE PROCEDURE. (B)(6) 2021: PROCEDURES PERFORMED: 1. ANTERIOR ARTHRODESIS WITH APPROACH TO C3, C4, C5, AND C6. 2. ANTERIOR CERVICAL HARDWARE REMOVAL AT C3, C4, C5, AND C6. 3. REMOVAL OF C5-C6 INTERBODY PEEK CAGE, REVISION AND REDO C5-C6 DISCECTOMY AND INTERBODY FUSION USING 11-MM TITAN TC CAGE FILLED WITH MORSELIZED AUTOGRAFT AND ALLOGRAFT. 4. ANTERIOR CERVICAL FUSION, C5-C6, WITH A 19 MM MEDTRONIC ZEVO PLATE. 5. USE OF INTRAOPERATIVE FLUOROSCOPY, LESS THAN 1 HOUR PHYSICIAN TIME. 6. USE OF NEUROMONITORING. 7. USE OF THE OPERATING MICROSCOPE. PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION BY SEVERAL MONTHS AGO FROM WHICH SHE DID QUITE WELL. IMAGING STUDIES DEMONSTRATED A BREAKAGE OF THE BACKOUT SCREW SYSTEM, AND THE PATIENT HAD MIGRATION OF HER BILATERAL INFERIOR SCREWS AT C6. THIS WAS CONCERNING FOR POSSIBLE PSEUDOARTHROSIS. DESCRIPTION OF THE PROCEDURE: THE PATIENT WAS BROUGHT TO THE OPERATING THEATER AND UNDERWENT GENERAL ENDOTRACHEAL ANESTHESIA WITHOUT COMPLICATION. SHE HAD VENODYNES, TED HOSE, APPROPRIATE LINES PLACED BY ANESTHESIA. HER HEAD WAS MAINTAINED SUPINE ON THE OPERATING TABLE WITH THE HEAD IN SLIGHT EXTENSION. ALL BONY PROMINENCES INSPECTED AND PADDED. USING LATERAL FLUOROSCOPY AND SPINAL NEEDLE, SURGEON PICKED OUR ENTRY POINT TO THE C3 THROUGH C6 LEVELS. THIS WAS MARKED AS A TRANSVERSE INCISION SLIGHTLY INFERIOR TO HER PRIOR INCISION. THIS AREA WAS THEN PREPPED AND DRAPED IN THE USUAL STERILE SURGICAL FASHION. TIMEOUT WAS COMPLETED PER PROTOCOL AND THE PATIENT RECEIVED ANTIBIOTICS WITHIN 1 HOUR OF INCISION. DR. (B)(6) FROM ENT THEN ASSISTED WITH THE ANTERIOR EXPOSURE THROUGH THE PREVIOUS ANTERIOR INCISION. THE DISSECTION WAS EXTREMELY TEDIOUS AND DIFFICULTY SECONDARY TO THE SCAR TISSUES, MAKING THIS SURGERY GREATER THAN 70% MORE DIFFICULT THAN NORMAL. WE CONTINUED WITH OUR DISSECTION UNTIL SURGEON IDENTIFIED THE PRIOR HARDWARE. THERE WAS A LOT OF SCAR TISSUE NOTED AROUND THIS AREA, BUT WE DID PROTECT THE ESOPHAGUS AND TRACHEA MEDIALLY AND THE CAROTID SHEATHS LATERALLY. SURGEON IDENTIFIED THE PRIOR HARDWARE INCLUDING THE SMALL BROKEN PIECE OF THE PLATE AND 2 SCREWS. SURGEON THEN SEQUENTIALLY REMOVED THE BILATERAL SCREWS FROM C3, C4, C5, AND C6 AND PASSED THEM OFF THE FIELD. SURGEON REMOVED THE ENTIRE PLATE AND PASSED IT OFF THE FIELD. WE EXPLORED THE C3-C4, C4-C5, AND C5-C6 LEVELS AND NOTED THE C3 THROUGH C5 LEVELS APPEARED TO BE SOLIDLY INFUSED. HOWEVER, AT C5-C6, THE PEEK INTERBODY CAGE WAS NOTED TO BE LOOSE. AT THIS POINT, THE MICROSCOPE WAS BROUGHT INTO THE FIELD TO ASSIST WITH MICROSCOPIC DISSECTION AND TO MAINTAIN ILLUMINATION AND MAGNIFICATION. CASPAR PINS WERE PLACED INTO C5 AND C6 AND WE PLACED C5-C6 INTO MILD DISTRACTION. SURGEON REMOVED AND DRILLED OUT THE PREVIOUS PEEK CAGE FROM THE C5-C6 DISC SPACE AND PASSED IT OFF THE FIELD. SURGEON REVISED AND PREPARED THE ENDPLATE OF C5. WE THEN COMPLETED A PARTIAL REMOVAL OF THE SUPERIOR ASPECT OF C6 TO GET GOOD ENDPLATE COVERAGE. SURGEON MEASURED THE INTERBODY SPACE AND PLACED AN 11 MM TITAN TC CAGE FILLED WITH MORCELLIZED AUTOGRAFT AND ALLOGRAFT IN THE C5-C6 DISC SPACE. SURGEON REMOVED THE CASPAR PINS, DRILLED DOWN THE ANTERIOR OSTEOPHYTES AND SECURED A 19 MM MEDTRONIC ZEVO PLATE ONTO THE VERTEBRAL BODIES OF C5 AND C6. AP AND LATERAL X RAYS DEMONSTRATED GOOD PLACEMENT OF THE HARDWARE. THE WOUND WAS IRRIGATED WITH GENTAMICIN IRRIGATION. SURGEON PLACED A DRAIN IN THE SUBFASCIAL SPACE AFTER OBTAINING HEMOSTASIS, AND THE WOUND THEN CLOSED IN MULTIPLE LAYERS INCLUDING VICRYL SUTURES FOR THE DEEP LAYERS AND DERMABOND FOR THE SKIN. THE PATIENT'S WOUNDS WAS DRESSED STERILELY. SHE WAS AWAKENED, EXTUBATED, AND TAKEN TO RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO COMPLICATIONS AND NO NOTED CHANGES ON NEUROMONITORING THROUGHOUT THE PROCEDURE. I REVIEWED HER IMAGING AND PLAN WITH THE PATIENT AGAIN THIS MORNING. SHE APPEARS TO BE SOLIDLY FUSED IN HER C3-C6 LEVELS BASED ON HER CT, BUT THE FACT THAT THE HARDWARE APPEARS TO BE MIGRATING SEEMS THERE IS MICROMOTION OR PSEUDOARTHROSIS AT THOSE LEVELS. SURGEONS EVALUATE INTRAOPERATIVELY, AND IF THERE IS NO MOTION DETECTED ON ATTEMPTS TO MOVE THE LEVELS, THEN WE WILL DETERMINE WHETHER TO REDO HER ACDF DEPENDING ON THE INTRAOPERATIVE FINDINGS. EXPOSURE FOR REMOVAL OF HARDWARE AND REVISION ACDF AT C3 TO C6. COMPLICATIONS: BLOOD LOSS FOR MY PORTION WAS MINIMAL. FINDINGS: THE PATIENT WAS FOUND TO HAVE A PRIOR NECK INCISION THAT WAS SLIGHTLY HIGH FOR WHERE WE WANTED TO GO, SO OUR INCISION WAS MADE ABOUT 2 CM BELOW THIS. SHE HAD SIGNIFICANT SCARRING AND VERY THICK FIBROUS TISSUE AND FIBROSIS OVER THE AREA OF THE PLATE, BUT WE WERE ABLE TO GET DOWN TO THIS WITHOUT ANY DIFFICULTY AND EXPOSED THE HARDWARE. PREOPERATIVE NOTE: CONSTANCE IS A VERY PLEASANT 75-YEAR-OLD WOMAN WHO HAS A HISTORY OF SOME NECK ISSUES. SHE HAS PREVIOUSLY HAD AN ACDF OF C3 TO C6. THIS WAS DONE ABOUT 9 MONTHS AGO. SHE CAME IN FOR EVALUATION AND THERE WAS NOTED TO BE EXTRUSION OF THE BOTTOM SCREWS AT C6. IT WAS FELT THAT SHE WOULD BENEFIT FROM THE ABOVE PROCEDURE AND DR. (B)(6) ASKED ME FOR ASSISTANCE WITH EXPOSURE. DESCRIPTION OF PROCEDURE: THE PATIENT WAS FIRST SEEN IN THE PREOPERATIVE AREA WHERE INFORMED CONSENT WAS OBTAINED. SHE WAS THEN BROUGHT BACK TO THE OPERATING ROOM. ANESTHESIA SEDATED AND INTUBATED HER. SHE WAS PREPPED AND DRAPED IN STERILE FASHION AND DR. (B)(6) PLACED A MARKER AT HER PRIOR INCISION TO CHECK IF THIS WAS THE RIGHT POSITION AND AN X-RAY WAS TAKEN. THIS LOOKED A LITTLE BIT HIGH AND SO WE ACTUALLY ENDED UP MAKING THE INCISION OF ABOUT 2 CM OR SO BELOW THIS AREA. ABOUT A 4-5 CM INCISION WAS MARKED OUT IN THE MID PORTION OF THE NECK JUST BELOW THE PRIOR SCAR. THIS WAS INJECTED WITH SOME LIDOCAINE WITH EPI. UNIVERSAL TIMEOUT PROTOCOL WAS PERFORMED CONFIRMING THE PATIENT AND THE PROCEDURE. ONCE WE HAD DONE THIS, A 15-BLADE WAS USED TO MAKE AN INCISION THROUGH THE SKIN AND SUBCUTANEOUS TISSUES AS WELL AS THE PLATYSMA. A SUBPLATYSMAL FLAP WAS ELEVATED SUPERIORLY AND INFERIORLY. WEITLANER RETRACTORS WERE USED FOR VISUALIZATION AND EXPOSURE. I WAS ABLE TO VISUALIZE THE SCM AS WELL AS THE STRAP MUSCULATURE. WE BEGAN DISSECTING BETWEEN THESE 2 STRUCTURES AND I USED GENTLE BLUNT DISSECTION ALONG THE LENGTH OF THIS AREA TO GET DOWN TO THE AREA OF THE SPINE. SHE DID HAVE SIGNIFICANT FIBROUS TISSUE AND SCARRING THROUGHOUT THIS WHOLE AREA AND SO CARE WAS TAKEN. I WAS ABLE TO FIND THE CAROTID SHEATH, AND THIS WAS KEPT LATERALLY. SOME RETRACTORS WERE USED TO HOLD THIS LATERALLY AND THE LARYNGOTRACHEAL COMPLEX AND THE ESOPHAGUS WAS PULLED MEDIALLY. I WAS ABLE TO DISSECT DOWN TO THE SPINE. SHE DID HAVE SIGNIFICANT THICK FIBROSIS OVER THE ENTIRE AREA. BLUNT AND SHARP DISSECTION WAS USED TO RELEASE THIS UNTIL WE WERE ABLE TO FIND THE LONGUS COLLI AS WELL AS THE EXTRUDED SCREWS. SO, AT THIS POINT, A PLASMA PEN WAS USED TO RELEASE THIS SCARRING AND FIBROSIS OFF OF THE UNDERLYING SCREWS AND PLATE FOR C3 TO C6. ONCE THIS WAS EXPOSED, ALL THE SCREWS WERE REMOVED, 8 IN TOTAL AND THEN THE ENTIRE PLATE WAS REMOVED. AT THIS POINT, MY PORTION OF THE PROCEDURE WAS DONE, AND I LEFT THE PROCEDURE. DR. (B)(6) COMPLETED THE PROCEDURE, AND HIS PORTION OF THE PROCEDURE WILL BE DICTATED SEPARATELY. SHE TOLERATED THIS WELL AND DID OKAY AND THERE WERE NO COMPLICATIONS FROM MY STANDPOINT.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (PATIENT, MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WITH STENOSIS DEGENERATIVE DISC DISEASE FOR ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SPINAL THERAPY AT C3-C6. IT WAS REPORTED THAT THE ZEVO LOCKING MECHANISM DETACHED FROM THE PLATE, ALLOWING THE SCREWS TO BACK OUT. THE LEVEL OF THE AREA WITH THE DETACHED LOCKING MECHANISM NEVER FUSED AND A REVISION SURGERY WAS NECESSARY. THERE WAS NECK PAIN AND ARM PAIN PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 759435 | ZEVO¿ ANTERIOR CERVICAL PLATE SYSTEM | KWQ | WARSAW ORTHOPEDICS | 3003045 | 00662191W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |