INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2013-00818
- Event Type
- Injury
- Date Received
- March 20, 2013
- Report Date
- May 18, 2016
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
Narratives
PRODUCTS FROM MULTIPLE MANUFACTURERS WERE USED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES OR MEDICAL RECORDS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
(B)(4).
(B)(4).
(B)(4).
(B)(4).
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.
(B)(4).
(B)(4). IMAGE REVIEW: RHBMP-2/ACS IMPLANTED: (B)(6) 2009 PATIENT COMPLAINT: LOW BACK PAIN, NUMBNESS, TINGLING, HEADACHES. (B)(6) 2009: THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSES: SPINAL STENOSIS, SPONDYLOSIS AND DEGENERATIVE SPONDYLOLISTHESIS. SHE UNDERWENT THE FOLLOWING OPERATIONS: 1. LAMINECTOMY, FASCIECTOMY, FORAMINOTOMY L4. 2. BILATERAL ARTHRODESIS L4-5. 3. PEDICLE SCREW INSTRUMENTATION L4-5. 4. LAMINECTOMY PARTIAL MEDIAL FASCIECTOMY, FORAMINOTOMY AT L5. 5. MORCELIZED AUTOGRAFT. 6. MORCELIZED ALLOGRAFT. 7. ANTERIOR LUMBAR DISCECTOMY RADICAL. 8. ANTERIOR LUMBAR ARTHRODESIS. 9. PLACEMENT OF ANTERIOR PROSTHETIC DEVICE. 10. MORCELLIZED ALLOGRAFT SURGERY. PER THE OP NOTES, THE APPROPRIATE SIZE PEEK SPACER WAS PACKED WITH MORCELIZED ALLOGRAFT AND RHBMP-2/ACS AND IMPACTED INTO POSITION. PORTIONS OF THE ALLOGRAFT WAS THEN PLACED OVER THIS GRAFT AND A 23 MM PLATE WAS APPLIED WITH 1 SCREW 30 MM IN LENGTH IN L4, TWO SCREWS 25 MM IN LENGTH IN L5. SATISFACTORY APPEARANCE OF THE INSTRUMENTATIONS ARTHRODESIS WAS OBTAINED USING BIPLANAR FLUOROSCOPIC IMAGING. NO PATIENT COMPLICATIONS WERE NOTED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT BACK SURGERY USING RHBMP-2/ACS. REPORTEDLY, THE PATIENT HAS "PROBLEMS, SOME OF THE PROBLEMS INCLUDE PAIN, MENTAL ANGUISH AND NERVE INJURIES."
IT WAS REPORTED THAT ON (B)(6) 2011: THE PATIENT PRESENTED WITH LOW BACK PAIN WITH RIGHT SIDED RADICULAR SYMPTOMS. THE PAIN RADIATES FROM THE LOW BACK INTO THE GLUTEAL AREA, DOWN TO THE POSTEROLATERAL ASPECT OF THE THIGH, AND INTO THE ANTEROLATERAL ASPECT OF THE LEG ON THE RIGHT SIDE. SHE HAS SOME NUMBNESS IN HER LEFT FOOT, BUT HER PRIMARY COMPLAINT INVOLVES THE RIGHT LEG. IMPRESSION: RECURRENT LUMBAR RADICULAR COMPLAINTS AFTER A LUMBAR FUSION APPROXIMATELY 2 YEARS AGO. ON (B)(6) 2011: THE PATIENT UNDERWENT X-RAYS OF THE LUMBAR SPINE DUE TO BACK PAIN. FINDINGS: ANTERIOR AND POSTERIOR STABILIZATION METAL HARDWARE IS PRESENT AT L4-5. THERE IS GRADE I ANTEROLISTHESIS OF L5 ON S1 THAT DOES NOT APPEAR TO CHANGE SIGNIFICANTLY DURING FLEXION OR EXTENSION. NO OTHER ALIGNMENT ABNORMALITIES ARE DEMONSTRATED. THE PATIENT ALSO UNDERWENT LUMBAR, CERVICAL, AND THORACIC MYELOGRAMS DUE TO LOW BACK PAIN WITH RIGHT LEG PAIN, NECK PAIN WITH BILATERAL HAND NUMBNESS AND MID BACK PAIN. IMPRESSION: BILATERAL EXTRADURAL DEFECTS AT L5-S1 WITH SMALL BILATERAL EXTRADURAL DEFECTS AT L3-4; NORMAL CERVICAL MYELOGRAM; NORMAL THORACIC MYELOGRAM. THE PATIENT UNDERWENT CT OF THE CERVICAL PAIN DUE TO NECK PAIN WITH BILATERAL HAND NUMBNESS. IMPRESSION: NORMAL CERVICAL SPINE CT. THE PATIENT UNDERWENT CT OF THE THORACIC SPINE DUE TO MID BACK PAIN. IMPRESSION: ANTERIOR HYPERTROPHIC SPURRING AT MULTIPLE LEVELS; OTHERWISE NORMAL THORACIC SPINE CT. THE PATIENT UNDERWENT CT OF THE LUMBAR SPINE DUE TO LOW BACK PAIN WITH RIGHT LEG PAIN. IMPRESSION: DEGE NERATIVE DISEASE AND PREVIOUS SURGERY WITH NARROWING OF EACH LATERAL RECESS AT L5-S1 AND NO DEFINITE HNP OR CENTRAL STENOSIS. ON (B)(6) 2011: THE PATIENT PRESENTED FOR FOLLOW-UP AFTER RADIOLOGY EXAMINATIONS. IMPRESSION: RECURRENT RADICULAR SYMPTOMATOLOGY SECONDARY TO DEGENERATIVE SPONDYLOLISTHESIS, WHICH HAS PROGRESSED SINCE HER SURGERY ALMOST THREE YEARS AGO. SHE HAS A MOTOR DEFICIT. ON (B)(6) 2011: THE PATIENT PRESENTED WITH THE FOLLOWING INDICATIONS FOR PROCEDURE: SYMPTOM OF PRECORDIAL CHEST DISCOMFORT, ISCHEMIC ANGINA CHEST PAIN,CONCERN OF UNSTABLE ANGINA; ABNORMAL CARDIAC STRESS TEST; HYPERTENSION, HYPERLIPIDEMIA, OBESITY; DIABETES MELLITUS. THE PATIENT UNDERWENT A LEFT-HEART CATHERTIZATION; CORONARY ANGIOGRAM; LV GRAM. ON (B)(6) 2012: THE PATIENT UNDERWENT X-RAYS OF THE LUMBAR SPINE DUE TO LUMBAR SPONDYLOSIS. IMPRESSION: PREVIOUS FUSION SURGERY; GRADE I SPONDYLOLISTHESIS OF L5 ON S1 AND THERE IS A SLIGHT LEVOROTOSCOLIOTIC CURVATURE TO THE LUMBAR SPINE; THERE IS MILD MULTI-LEVEL DISC SPACE NARROWING. THE ALIGNMENT OF THE SPINE IS UNCHANGED WHEN COMPARED TO THE PRIOR STUDY OF (B)(6) 2011.
PER MEDICAL RECORDS, IT WAS REPORTED THAT PATIENT HAD TO LEFT HER JOB DUE TO PAIN IN HER KNEES, BACK, AND A SUBDURAL HEMATOMA. APART FROM RH-BMP2, PATIENT WAS IMPLANTED WITH CAPSTONE VERTE PEEK CAGE; POSTERIOR FIXATION USING SCREWS. PATIENT REPORTED THAT MECHANICAL LOWER BACK PAIN AT THE L4-L5 LEVEL CAUSING NECK AND BACK PAIN AND DIFFICULTY SITTING FOR LONG PERIODS OF TIME LED TO HER RH-BMP2 TREATMENT. PER MEDICAL RECORDS, IT WAS REPORTED THAT IN YEAR 2007, PATIENT UNDERWENT FACET EPIDURAL INJECTION FOR BACK AND NECK PAIN. POST-OP INFUSE TREATMENT, PATIENT ALLEGED INJURIES INCLUDING, BUT ARE NOT LIMITED TO EXTREME PAIN WHICH MAKES IT DIFFICULT TO WALK OR STAND, MECHANICAL LOWER BACK PAIN, DIFFICULTY BREATHING AND SWALLOWING, GASTROINTESTINAL PROBLEMS, LOCALIZED EDEMA IN THE LEGS, NERVE INJURY, OSTEOARTHRITIS, TINGLING OF FEET, RADIATING PAIN, ANXIETY AND DEPRESSION. PATIENT ALSO HAD TO HAVE A REVISION SURGERY IN (B)(6) 2011 AND IS UNABLE TO PARTICIPATE IN PHYSICAL ACTIVITIES. ON (B)(6) 2013, PATIENT UNDERWENT ANTERIOR CERVICAL DISC FUSION SURGERY.
IT WAS REPORTED THAT ON ON (B)(6) 2009 THE PATIENT UNDERWENT X-RAYS OF PA CHEST, ONE VIEW. IMPRESSION: NO ACUTE CARDIOPULMONARY ABNORMALITY. ON (B)(6) 2009 THE PATIENT UNDERWENT CT SCAN OF LUMBAR SPINE WITHOUT CONTRAST. IMPRESSION: POSTOPERATIVE CHANGES IN THE LOWER LUMBAR SPINE AS DESCRIBED WITH GOOD ALIGNMENT MAINTAINED. ON (B)(6) 2009 THE PATIENT UNDERWENT X-RAYS OF CHEST ONE VIEW. IMPRESSION: THERE IS SUBSEGMENTAL ATELECTASIS AT THE RIGHT LUNG BASE. LUNG VOLUMES ARE LOW, BUT NO CONVINCING INFILTRATE IS IDENTIFIED. THE CARDIAC SILHOUETTE IS NORMAL IN SIZE. ON (B)(6) 2009 THE PATIENT UNDERWENT X-RAYS OF CHEST SINGLE VIEW. IMPRESSION: THERE WAS ELEVATED RIGHT HEMIDIAPHRAGM WITH HYPOAERATION OF THE RIGHT BASE. LINEAR SUB-SEGMENTAL ATELECTASIS WAS PRESENT IN THE LEFT PERIHILAR REGION AND HAD DEVELOPED SINCE THE PRIOR STUDY OF TWO DAYS AGO. THE REMAINDER OF THE STUDY WAS OTHERWISE UNCHANGED. ON (B)(6) 2011 THE PATIENT PRESENTED WITH CHIEF COMPAINTS OF MECHANICAL LOW BACK PAINAND RIGHT LOWER EXTREMITY PAIN. IMPRESSION: THE PATIENT PRESENTS WITH RECURRENT RADICULAR SYMPTOMS SECONDARY TO A DEGENERATIVE SPONDYLOLISTHESIS, WHICH HAS PROGRESSED SINCE HER PREVIOUS LUMBAR FUSION ALMOST 3 YEARS AGO, WITH NOTED MOTOR DEFICIT ; HYPERTENSION, ESSENTIALLY CONTROLLED ON PRESENT MEDICATION REGIMEN. THE PATIENT UNDERWENT X-RAYS OF CHEST SINGLE VIEW. IMPRESSION: STABLE CHEST WITH CHRONIC ELEVATION OF THE RIGHT HEMIDIAPHRAGM.
IT WAS REPORTED THAT ON (B)(6) 2006 PATIENT ADMITTED IN HOSPITAL DUE TO CHEST PAIN. PATIENT UNDERWENT X-RAY. ON (B)(6) 2006 PATIENT DISCHARGED FROM HOSPITAL. ASSESSMENT: CHEST PAIN AND PALPITATIONS-RULE OUT OANY CORONARY ARTERY DISEASE; RULE OUT ANY CARDIAC DYSRHYTHMIA SECONDARY TO HER HYPERTENSION; RULE OUT OF GASTROESOPHAGEAL REFULUX DISEASE. PATIENT PRESENTED FOR X-RAY AND ULTRASOUND: FRONTAL VIEW OF THE CHEST: THE HEART, PULMONARY VASULATURE AND BOTH IMAGE WERE NORMAL. THERE WAS ELEVATION OF THE RIGHT HEMIDIAPHRAGM. THE PLEURAL SURFACES WERE NORMAL AND THE BONY THROAXWAS INTACT (B)(6) 2007 PATIENT UNDERWENT TO HOSPITAL IN EMERGENCY ROOM DUE TO ELBOW AND ARM PAIN. LEFT FOREARM: AP AND LATERAL VIEWS. NO BONY PATHOLOGY WAS SEEN THERE WERE NO DEMONSTRABLE SOFT TISANE DEFECTS. LEFT ELBOW: AP AND LATERAL VIEWS. NO BONY PATHOLOGY WAS SEEN AND THE JOINT SPACES WERE NORMAL. NO SIGNS OF JOINT EFFUSION WERE FOUND. ON (B)(6) 2008 PATIENT PRESENTED WITH NAUSEA AND SWEATING, PALPITATION (B)(6) 2008 PATIENT UNDERWENT TO HOSPITAL IN EMERGENCY ROOM. PATIENT WAS DISCHARGE WITH INSTRUCTIONS. ON (B)(6) 2008 PATIENT UNDERWENT TO HOSPITAL IN EMERGENCY ROOM. CLINICAL IMPRESSION: CERVICAL STRAIN. ON (B)(6) 2008 PATIENT UNDERWENT TO HOSPITAL IN EMERGENCY ROOM. CLINICAL IMPRESSION: CERVICAL STRAIN.
IT WAS REPORTED THAT ON (B)(6) 2014: PATIENT PRESENTED WITH DIABETES. ASSOCIATED SYMPTOMS INCLUDED FREQUENT URINATION, DRY MOUTH AND STAYED THIRSTY. PHYSICAL EXAM REVEALED HIS ANXIOUS PSYCHIATRIC CONDITION. ASSESSMENT: HYPERTENSION; DIABETES MELLITUS, ANXIETY, BMI (B)(6). (B)(6) 2015: PATIENT PRESENTED FOR FOLLOW WITH CHRONIC CONDITIONS. ASSESSMENT: HYPERTENSION; DIABETES MELLITUS, ANXIETY. (B)(6) 2015: PATIENT PRESENTED FOR FOLLOW WITH CHRONIC CONDITIONS. ASSESSMENT: HYPERTENSION; DIABETES MELLITUS. (B)(6) 2011 THE PATIENT PRESENTED WITH RIGHT KNEE PAIN, HANDS TINGLING AND BILATERAL FOOT NUMBNESS; ASSESSMENT: BACK PAIN WITH RADIATION: CHRONIC, CONTROLLED; PAIN, FOOT: CHRONIC, NOT CONTROLLED; PAIN, HAND: CHRONIC, NOT CONTROLLED; PAIN, KNEE: CHRONIC, NOT CONTROLLED. (B)(6) 2012 THE PATIENT PRESENTED FOR A FOLLOW UP FOR COMPLAINTS OF PAIN IN LEFT KNEE AND SOME PAIN IN HER RIGHT ELBOW. ASSESSMENT: KNEE PAIN. (B)(6) 2012 THE PATIENT COMPLAINED OF PAIN IN HER LEFT KNEE. AN MRI SHOWED CARTILAGE IN THE LEFT KNEE AND OSTEOPOROSIS. THE PATIENT DESCRIBED THE PAIN AS STABBING WHEN LAYING ON RIGHT SIDE BUT CONSTANT ACHING OTHERWISE. ASSESSMENT: OSTEOPOROSIS; KNEE PAIN; REFLUX ESOPHAGITIS. (B)(6) 2012 THE PATIENT PRESENTED FOR A FOLLOW UP FOR NECK AND BACK PAIN. THE PATIENT DESCRIBES THE PAIN AS THROBBING AND SHARP. SHE HAD PAIN IN HER LEFT HEAL AND NUMBNESS IN BOTH HANDS AND FEET. ASSESSMENT: BACK PAIN WITH RADIATION: CHRONIC, CONTROLLED; ANXIETY STATE: CHRONIC, CONTROLLED; PAIN, FOOT: CHRONIC, CONTROLLED; PAIN, KNEE: CHRONIC, CONTROLLED. (B)(6) 2013 THE PATIENT COMPLAINED OF PAIN IN HER RIGHT ARM AND BILATERAL KNEES. ASSESSMENT: ANXIETY; GENERALIZED PAIN; KNEE PAIN; PAIN IN UPPER LIMB. (B)(6) 2013 THE PATIENT COMPLAINED OF NUMBNESS IN HANDS AND LOW BACK PAIN. ASSESSMENT: ANXIETY; GENERALIZED PAIN; MUSCLE SPASM; CERVICAL SPONDYLOSIS; BACK PAIN; PAIN IN UPPER LIMB. (B)(6) 2013 THE PATIENT PRESENTED WITH MUSCLE SPASM, OSTEOPOROSIS AND KNEE PAIN. ON EVALUATION, THERE WAS SWELLING OF KNEE DELAYED AND PARESTHESIA OF LOWER EXTREMITY. ASSESSMENT: ANXIETY; GENERALIZED PAIN; MUSCLE SPASM; OSTEOPOROSIS; KNEE PAIN; CERVICAL SPONDYLOSIS. (B)(6) 2014 THE PATIENT COMPLAINED OF LOW BACK PAIN. ASSESSMENT: LOW BACK PAIN; KNEE PAIN; OSTEOARTHRITIS OF KNEE; SPASM OF BACK MUSCLES. (B)(6) 2014 THE PATIENT COMPLAINED OF RIGHT HIP-LEG PAIN, NECK AND KNEE PAIN. ASSESSMENT: NECK PAIN; CHRONIC LOW BACK PAIN; ANXIETY; CERVICAL SPONDYLOSIS; HIP PAIN. (B)(6) 2014 THE PATIENT COMPLAINED OF KNEE PAIN. THE PAIN WAS BETTER SINCE LAST VISIT. ASSESSMENT: CHRONIC PAIN SYNDROME; KNEE PAIN; OSTEOARTHRITIS OF KNEE; CERVICAL SPONDYLOSIS. (B)(6) 2014 THE PATIENT PRESENTED WITH BILATERAL KNEE AND RIGHT SHOULDER PAIN. THE PATIENT DESCRIBED THE PAIN AS CONSTANT ACHE. ON EVALUATION, THERE WAS REDUCED RANGE OF MOTION OF BACK, PARESTHESIA OF LOWER EXTREMITY, AND LEG WEAKNESS. ASSESSMENT: NECK PAIN; LOW BACK PAIN; PAIN IN UPPER LIMB; CERVICAL SPONDYLOSIS. (B)(6) 2014 THE PATIENT COMPLAINED OF LEFT FOOT AND BACK PAIN. ASSESSMENT: KNEE PAIN; LOW BACK PAIN; GOUT; HYPERTENSIVE DISORDER; FOOT PAIN; HIP PAIN (B)(6) 2014 THE PATIENT COMPLAINED OF LOW BACK PAIN. THE PATIENT DESCRIBED THE PAIN AS CONSTANT AND SHARP. ASSESSMENT: KNEE PAIN; CERVICAL SPONDYLOSIS; CHRONIC LOW BACK PAIN; HIP PAIN; ESSENTIAL HYPERTENSION; LOW BACK PAIN (B)(6) 2014 THE PATIENT COMPLAINED OF LOW BACK PAIN WITH RADIATION INTO BILATERAL FEET. THE PATIENT DESCRIBED THE PAIN AS CONSTANT ACHE. ASSESSMENT: KNEE PAIN; LOW BACK PAIN; GOUT; HYPERTENSIVE DISORDER; FOOT PAIN; (B)(6) 2014 THE PATIENT COMPLAINED OF LOW BACK PAIN, OSTEOARTHRITIS OF KNEE AND OSTEOPOROSIS. ASSESSMENT: CHRONIC PAIN SYNDROME; LOW BACK PAIN; OSTEOARTHRITIS OF KNEE; CHRONIC LOW BACK PAIN. (B)(6) 2015 THE PATIENT COMPLAINED OF CHRONIC LOW BACK PAIN. THE PATIENT DESCRIBED THE PAIN AS SEVERE AND ACHING. ASSESSMENT: CHRONIC PAIN SYNDROME; LOW BACK PAIN; ESSENTIAL HYPERTENSION; CERVICAL SPONDYLOSIS; CHRONIC LOW BACK PAIN. (B)(6) 2015 THE PATIENT COMPLAINED OF LOW BACK PAIN. THE PATIENT DESCRIBED THE PAIN AS ACHING. ASSESSMENT: KNEE PAIN; LOW BACK PAIN; HIP PAIN; HYPERTENSIVE DISORDER; FOOT PAIN; CHRONIC PAIN SYNDROME. (B)(6) 2015 THE PATIENT COMPLAINED OF HIP AND BACK PAIN. THE PATIENT DESCRIBED THE PAIN AS ACHING. ASSESSMENT: KNEE PAIN; CERVICAL SPONDYLOSIS; CHRONIC LOW BACK PAIN; HIP PAIN; HYPERTENSIVE DISORDER; LONG-TERM DRUG THERAPY; LOW BACK PAIN; PAIN RADIATING TO LUMBAR REGION OF BACK; SPASM OF BACK MUSCLES. (B)(6) 2015 THE PATIENT COMPLAINED OF KNEE AND BACK PAIN. THE PATIENT UNDERWENT X-RAYS OF THE KNEE DUE TO KNEE PAIN. IMPRESSION: MILD RIGHT AND MILD TO MODERATE LEFT KNEE OSTEOARTHROSIS. OSSIFICATION ADJACENT TO MEDIAL FEMORAL CONDYLE CAN BE SEEN WITH PREVIOUS MEDIAL COLLATERAL LIGAMENT INJURIES. ASSESSMENT: KNEE PAIN; LOW BACK PAIN; OSTEOARTHRITIS OF KNEE (B)(6) 2015 THE PATIENT PRESENTED FOR A FOLLOW UP FOR MED REFILL AND COMPLAINED OF BILATERAL KNEE PAIN. THE PATIENT DESCRIBED THE PAIN AS CONSTANT AND ACHING. SHE ALSO REPORTED LOW BACK PAIN, BACK STIFFNESS, KNEE JOINT TENDERNESS AND ABNORMAL KNEE RANGE OF MOTION. ASSESSMENT: KNEE PAIN; HIP PAIN; LOW BACK PAIN; OSTEOARTHRITIS OF KNEE; PAIN IN UPPER LIMB. ON (B)(6) 2008 PER BILLING RECORDS, THE PATIENT UNDERWENT ULTRASOUND. THE PATIENT ALSO UNDERWENT CT OF HEAD WITHOUT CONTRAST. ON (B)(6) 2008 PER BILLING RECORDS, THE PATIENT UNDERWENT A CT OF HEAD WITHOUT CONTRAST. ON (B)(6) 2008 PER BILLING RECORDS, THE PATIENT UNDERWENT MRI OF CERVICAL AND LUMBAR SPINE WITHOUT CONTRAST. ON (B)(6) 2008 THE PATIENT PRESENTED WITH COMPLAINTS OF HYPERTENSION AND HEADACHES. THE PATIENT UNDERWENT CT SCAN OF THE BRAIN. IMPRESSION: MIXED DENSITY SUBDURAL HEMATOMA WITH PROGRESSIVE DECLINE IN LEVEL OF CONSCIOUSNESS. THE PATIENT PRESENTED WITH PRE-OP DIAGNOSES OF ACUTE SUBDURAL HEMATOMA AND LEFT OBTUNDATION AND UNDERWENT LEFT FRONTOPARIETAL TEMPORAL CRANIOTOMY FOR EVACUATION OF ACUTE SUBDURAL HEMATOMA. THE PATIENT UNDERWENT X-RAYS OF CHEST, 1 VIEW. IMPRESSION: BILATERAL PERIHILAR INFILTRATES WERE IDENTIFIED. ATELECTASIS WAS IDENTIFIED IN ASSOCIATION WITH ELEVATION OF THE RIGHT HEMIDIAPHRAGM. THE PATIENT UNDERWENT X-RAYS OF AP PORTABLE CHEST DUE TO NEW ONSET FEVER. IMPRESSION: ELEVATION OF THE RIGHT HEMIDIAPHRAGM WITH ADJACENT COMPRESSIVE ATELECTASIS. PERSISTENT, BUT MILDLY IMPROVED, LEFT PERIHILAR ATELECTASIS. THE PATIENT UNDERWENT CT CTA OF HEAD DUE TO SUBDURAL HEMATOMA. IMPRESSION; 1. NO EVIDENCE OF SIGNIFICANT VASCULAR ABNORMALITY WAS IDENTIFIED; 2. A LEFT SUBDURAL HEMATOMA WAS IDENTIFIED WITH MODERATE INTRACRANIAL MASS EFFECT. ON (B)(6) 2008 THE PATIENT UNDERWENT US DUPLEX VEN UPPER EXT BILATERAL. IMPRESSION: NO SONOGRAPHIC EVIDENCE OF DVT IDENTIFIED WITHIN EITHER UPPER EXTREMITY. THE PATIENT ALSO UNDERWENT US DUPLEX VEN LOWER EXT BILATERAL. IMPRESSION: NO SONOGRAPHIC EVIDENCE OF DVT IDENTIFIED WITHIN EITHER LOWER EXTREMITY. THE PATIENT UNDERWENT CT OF HEAD W/O CONTRAST DUE TO POST-OP EVACUATION OF SUBDURAL HEMATOMA. IMPRESSION: 1. INTERVAL EVACUATION OF THE BASE NOTED ACUTE ON CHRONIC LEFT SUBDURAL HEMATOMA OVER THE LEFT FRONTAL CONVEXITY. MINIMAL PERSISTENT SUBFALCINO SHIFT THE RIGHT, APPROXIMATELY 2 MM, WAS NOTED; 2. PERSISTENT, BUT IMPROVED, UNEAL HERNIATION AND LOSS TONSILLAR HERNIATION NOTED. THE PATIENT UNDERWENT X-RAYS OF AP PORTABLE CHEST DUE TO POSSIBLE INFILTRATES. IMPRESSION: IMPROVED PERIHILAR ATELECTASIS ALTHOUGH BILATERAL BASILAR ATELECTASIS REMAIN. ON (B)(6) 2008 THE PATIENT UNDERWENT CT OF HEAD W/O CONTRAST. IMPRESSION: 1. SMALL LEFT CONVEXITY MIXED DENSITY SUBDURAL HEMATOMA, MILDLY INCREASED SINCE (B)(6) 2008 WITH INCREASE IN LEFT-TO-RIGHT MIDLINE SHIFT FROM 2 TO 5 MM AND OBLITERATION OF THE BASAL CISTERNS, NEW; 2. OTHERWISE UNCHANGED. ON (B)(6) 2008 THE PATIENT UNDERWENT CT OF HEAD W/O CONTRAST AS FOLLOW-UP OF SUBDURAL HEMATOMA. IMPRESSION: LEFT FRONTOPARIETAL CRANIOTOMY WITH UNDERLYING MIXED DENSITY SUBDURAL HEMALOMA. THE FINDINGS WERE UNCHANGED AS COMPARED TO PRIOR EXAMINATION WITH APPROXIMATELY 5 MM SUBFALCINE SHIFT. ON (B)(6) 2008 THE PATIENT UNDERWENT ACT HEAD W/O CONTRAST, DUE TO SUBDURAL HEMORRHAGE. CONCLUSION: PREVIOUSLY SEEN LEFT-SIDED SUBDURAL HEMALOMA HAS NOW RESOLVED. ON (B)(6) 2008 THE PATIENT UNDERWENT MRI OF LUMBAR SPINE WITHOUT CONTRAST, DUE TO LOWER BACK PAIN. CONCLUSION: LOWER LUMBAR SPONDYLOSIS. THERE WAS NO SIGNIFICANT CANAL OR FORAMINAL COMPROMISE. THE PATIENT UNDERWENT MRI OF CERVICAL SPINE W/O CONTRAST, DUE TO NECK PAIN. CONCLUSION: MILD MULTILEVEL CERVICAL SPONDYLOSIS WITH NO SIGNIFICANT CANAL OR FORAMINAL COMPROMISE. ON (B)(6) 2011 THE PATIENT UNDERWENT INTRAOPERATIVE NEUROPHYSIOLOGIC MONITORING. CONCLUSION: IT DEMONSTRATED INTACT SENSORY AND MOTOR PATHWAYS OF THE LOWER EXTREMITIES. ELECTRICAL SIMULATION OF THE PEDICLE SCREWS WAS SUGGESTIVE OF INTRAOSSEOUS PEDICLE SCREW PLACEMENT. INDICATIONS: THE PATIENT HAD PREVIOUSLY UNDERWENT LUMBAR FUSION A T L4-5 WHO HAS DEVELOPED SEVERE RADICULAR SYMPTOMS ON THE RIGHT WITH MECHANICAL LOW BACK PAIN AS WELL AS MRI STUDY THAT SHOWED PROGRESSION OF SPONDYLOLISTHESIS A T L 5 -5 1 . SUBSEQUENT RECOMMENDATION MADE FOR OPERATIVE INTERVENTION . PER OP NOTES, THE APPROPRIATE SIZE PEEK IMPLANT WAS IMPACTED IN TO POSITION WITH SATISFACTORY SEATING BEING NOTED. THIS HAD BEEN PACKED WITH A COMBINATION OF MORSELIZED AUTOGRAFT AND ALLOGRAFT . THE DISK SPACE WAS THEN BACK FILLED WITH MULTIPLE FRAGMENTS OF MORSELIZED AUTOGRAFT AND ALLOGRAFT SO AS TO PERFORM A INTERBODY FUSION. THERE WERE NO PATIENT COMPLICATIONS AND THE SURGERY WAS UNEVENTFUL.
IT WAS REPORTED THAT ON, (B)(6) 2008: PATIENT UNDERWENT X-RAY OF KNEES. ON (B)(6) 2008: PATIENT PRESENTED FOR OFFICE VISIT DUE TO PAIN FOR FOLLOW UP (B)(6) 2011, : PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2011: PATIENT PRESENTED FOR OFFICE VISIT.PATIENT UNDERWENT EKG( ELECTROCARDIOGRAM). ON (B)(6) 2012, (B)(6) 2013 : PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2013 PATIENT PRESENTED DUE TO LBP, STRESS. ON (B)(6) 2014 THE PATIENT DUE TO LUMBAGO, CERVICALGIA. ON (B)(6) 2014 PATIENT PRESENTED DUE TO MUSCLE SPASM AND CERVIVCAL ¿SPONDY¿. ON (B)(6) 2016 PATIENT PRESENED DUE TO PAIN IN RIGHT LEG.
IT WAS REPORTED THAT ON, (B)(6) 2008: PATIENT UNDERWENT LEFT FRONTAL PARIETOTEMPORAL CRANIOTOMY FOR ACUTE SUBDURAL HEMATOMA. ON (B)(6) 2008: PATIENT WAS DISCHARGED. AS PER DISCHARGE SUMMARY ,PATIENT UNDERWENT CRANIOTYOMY FOR EVACUATION OF SUBDURAL HEMATOMA WITHOUT COMPLICATION. ON (B)(6) 2008: PATIENT PRESENTED FOR FOLLOW UP STATUS POST LEFT PARIETOTEMPORAL CRANIOTOMY FOR ACUTE SUBDURAL HEMATOMA. IMPRESSION: EXCELLENT RESULT STATUS POST SUBDURAL HEMATIOMA AND EVACUATION. ON (B)(6) 2008: PATIENT PRESENTED FOR OFFICE VISIT WITH LUMBAR AND CERVICAL COMPLAINTS. PATIENT PRESENTED WITH COMPAINTS OF NUMBNESS IN HER RIGHT HAND,NECK PAIN,BILATERAL UPPER EXTREMITY PAIN,LOW BACK AIN AND LEFT SIDED LEG PAIN. PATIENT PRESENTED WITH CHIEF COMPLAINT OF PAINFUL PARESTHESIA IN THE HANDS AND IN THE FEET. THE SENSORY EXAMINATION SHOWS MILDLY REDUCED SENSATION TO PINPRICK,THERMAL SENSE AND LIGHT TOUCH IN BOTH LOWER EXTREMITIES ALONG THE L5 ROOT TARGET BILATERALLY AND ALONG THE RIGHT S1 ROOT TARGET.PATIENT UNDERWENT BILATERAL UPPER AND LOWER EXTREMITY EMG/NCV TEST.CONCLUSION: THERE IS EVIDENCE OF BILATERAL MILD ACTIVE L5 AND RIGHT MODERATE ACTIVE S1 RADICULOPATHY. ON (B)(6) 2008: PATIENT PRESENTED FOR FOLLOW UP WITH COMPLAINTS OF MECHANICAL LOW BACK PAIN AND BILATERAL RADICULAR SYMPTOMS AS WELL AS SHOULDER PAIN..IMPRESSION: LUMBAR SPONDYLOSIS WITH SEVERE PAIN REFRACTORY TO CONSERVATIVE THERAPY WITH DEGENERATIVE SPONDYLOLISTHESIS. PATIENT UNDERWENT X-RAY OF CERVICAL SPINE WITH FLEXION AND EXTENSION DUE TO NECK PAIN.IMPRESSION: MILD DEGENERATIVE DISC DISEASE.NO CERVICAL INSTABILITY. PATIENT UNDERWENT X-RAY OF LUMBAR SPINE WITHOUT BENDING DUE TO BACK PAIN. IMPRESSION: L4-L5 SPONDYLOLISTHESIS.THIS MAY BE CONGENITAL, POSTTRAUMATIC OR DEGENERATIVE. ON (B)(6) 2008: PATIENT PRESENTED FOR FOLLOW UP WITH COMPLAINTS OF CERVICALGIA AND NUMBNESS AND TINGLING IN THE BILATERAL HANDS AND FEET. SHE ALSO HAS LEFT ELBOW PAIN. ON PHYSICAL EXAMINATION, PATIENT HAS BILATERAL SI JOINT TENDERNESS TO PALPATION. PATIENT UNDERWENT X-RAY OF LUMBAR SPINE WITH BENDING DUE TO LOW BACK PAIN.IMPRESSION: GRADE 1 SPONDYLOLISTHESIS AT THE L4-L5 DISC LEVEL WITH SLIGHT INCREASE IN ANTERIOR SUBLUXATION DURING FLEXION. PATIENT UNDERWENT X-RAY OF CERVICAL SPINE WITH FEXION AND EXTENSION DUE TO CERCVICALGIA.IMPRESSION: NO IN STABILITY ON FLEXION-EXTENSION.MILD SPONDYLITIC CHANGE,STABLE. ON (B)(6) 2008: PATIENT PRESENTED FOR OFFICE VISIT AND COMPLAIN OF LOT OF JOINT PAIN AND TENDERNESS OF RIGHT HAND.
ON (B)(6) 2011: PATIENT PRESENTED FOR FOLLOW UP. DIAGNOSES: NECK PAIN, BACK PAIN AND LUMBAR SPONDYLOSIS. ON (B)(6) 2011: PATIENT PRESENTED WITH LOW BACK PAIN. ON (B)(6) 2011: PATIENT PRESENTED FOR POSTOPERATIVE WOUND CHECK. PATIENT WAS PROGRESSING WELL STATUS POST RECENT LUMBAR FUSION. DIAGNOSIS: LUMBAR SPONDYLOSIS. ON (B)(6) 2012: PATIENT PRESENTED WITH SOME PAIN IN THE RIGHT KNEE. PATIENT STATED THAT THE PAIN SHE WAS EXPERIENCING PREOPERATIVELY WAS SOMEWHAT IMPROVED. PATIENT STILL COMPLAINED OF SOME LOW BACK PAIN AND INCISIONAL AREA TYPE PAIN. X-RAY OF LUMBAR SPINE SHOWED STABLE PLACEMENT OF ALL INSTRUMENTATION WITHOUT MOVEMENT OR MALALIGNMENT. ON (B)(6) 2012: PATIENT PRESENTED FOR FOLLOW UP POST LUMBAR FUSION.
IT WAS REPORTED THAT ON (B)(6) 2004, PER OP NOTES, THE PATIENT VISITED THE FACILITY. (B)(6) 2004, THE PATIENT PRESENTED FOR PRE-OP INDUCTION. (B)(6) 2004, THE PATIENT PRESENTED FOR LABORATORY EXAMINATION. (B)(6) 2004, THE PATIENT VISITED THE FACILITY. (B)(6) 2004, THE PATIENT UNDERWENT DOBUTAMINE STRESS ECHOCARDIOGRAM TEST. (B)(6) 2004, PER THE RECORDS THE PATIENT UNDERWENT ARTHROSCOPY IN LEFT KNEE. NO COMPLICATIONS WERE REPORTED. (B)(6) 2005, THE PATIENT HAD LABORATORY EXAMINATION. (B)(6) 2005, THE PATIENT WAS ADMITTED FOR PARTIAL TENDON TEAR AT RIGHT ELBOW. 04/30/07, THE PATIENT PRESENTED FOR SURGERY CLEARANCE. SHE UNDERWENT BMP, CBC AND ECG EXAMINATION. (B)(6) 2007, THE PATIENT WAS ADMITTED FOR LEFT KNEE ARTHROSCOPY WITH MEDIAL AND LATERAL MENISECTOMY. NO COMPLICATION REPORTED POST OP. (B)(6) 2008, THE PATIENT PRESENTED WITH NECK PAIN. (B)(6) 2008, THE PATIENT VISITED THE FACILITY. (B)(6) 2011, THE PATIENT PRESENTED WITH CHEST PAIN. HYPERTENSION, SURGERY CLEARANCE. THE PATIENT UNDERWENT TRASTHORACIC ECHOCARDIOGRAPHY. (B)(6) 2011 THE PATIENT PRESENTED WITH CHEST PAIN. HYPERTENSION, SURGERY CLEARANCE. THE PATIENT UNDERWENT LEXISCAN NUCLEAR CARDIOLITE STRESS TEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116048 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |