INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2012-02804
- Event Type
- Injury
- Date Received
- December 13, 2012
- Report Date
- November 13, 2012
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- ATTORNEY
Narratives
(B)(6). (B)(4). REVIEW OF IMAGING STUDIES FOUND AS FOLLOWS: (B)(6) 2008 MRI LUMBAR SAGITTAL VIEWS SHOW SPONDYLOLISTHESIS AT L4 GRADE ONE, SEVERE DDD WITH HIGH-GRADE STENOSIS AT L3/4 AND L2/3. AXIAL VIEWS VERIFY SEVERE STENOSIS AT L2/3 AND L3/4 WITH NEARLY COMPLETE BLOCK AT THOSE LEVELS. L4/5 SPONDY SHOWS FORAMINAL STENOSIS WITH SUBLUXATION OF FACET JOINTS. (B)(6) 2010 LUMBAR MYELOGRAM CT STENOSIS HAS BEEN RESOLVED THROUGH LAMINECTOMY, INTERBODY FUSIONS, SPACERS AND PEDICLE SCREWS ARE NOW IN PLACE. DURAL SAC NARROWING STILL PRESENT ACROSS THE AREA OF SPONDYLOLISTHESIS AT L4/5. (B)(6) 2010 CT LUMBAR SACRAL CT DIRECTED NEEDLE INJECTION RIGHT SIDE POSSIBLY SYMPATHETIC BLOCK. (B)(6) 2011 CT SCAN LUMBAR SHOWS LAMINECTOMY L2 TO S1 WITH PEDICLE SCREWS, FEMORAL RING ALLOGRAFTS WITH RETAINING PLATES AND SCREWS AT L4 AND L5. CLYDESDALE IMPLANT PLACED LATERALLY ON THE LEFT AT L3. POSTEROLATERAL FUSION NOTED AS WELL WHICH APPEARS SOLID. (B)(6) 2011 AP AND LATERAL LUMBAR FILMS SHOW CONSTRUCT L2 THROUGH S1 WITH FULL DECOMPRESSIVE LAMINECTOMY, TLIF AT L3, LARGE ALIF WITH PLATE L4 AND L5. OPTIMAL LUMBAR LORDOSIS IS REESTABLISHED (B)(6) 2011 MYELOGRAM AND POST MYELOGRAM CT LUMBAR WO CONTRAST SHOWS STENOSIS AS NOT ED AT T12/L1 AS WELL AS AT THE L4/5 SLIP AREA. ARTHRITIS IS PRESENT THROUGH MOST SEGMENTS. ARTHRODESIS PRESENT INTERBODY FROM L3 DISTALLY. POSTEROLATERAL FUSION NOTED L3 TO THE SACRUM AS WELL. ALL CONSTRUCT COMPONENTS REMAIN INCLUDING ANTERIOR FEMORAL RINGS, RETAINING PLATES AND SCREWS AT L4 AND L5, CLYDESDALE AND DLIF AT L3, PL FUSION WITH SEGMENTAL PEDICLE SCREWS. (B)(6) 2012 MRI LUMBAR W/WO CONTRAST SAGITTAL T2 SHOWS INTERBODY SPACERS WITH SOLID ARTHRODESIS. SPONDYLOLISTHESIS AT L4/5 REMAINS. AXIAL VIEWS SHOW GOOD DECOMPRESSION WITH FLUID COLLECTIONS DORSAL TO THE DURAL SAC. SOME STENOSIS AT T12/ L1 IS NOTED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE RE PORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED 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.
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH KYPHOSCOLIOSIS L2-S1, SPINAL STENOSIS L3-S1, RIGHT L2-3 DISC HERNIATION, AND SPONDYLOLISTHESIS L5-S1. THE PATIENT UNDERWENT 360 FUSION, INCLUDING L3, L4, L5 LAMINECTOMY, RIGHT L2-3 DISCECTOMY, POSTERIOR SPINAL FUSION L2-S1 WITH PEDICLE SCREW INSTRUMENTATION WITH POSTEROLATERAL BONE GRAFTING, AND ANTERIOR LUMBAR INTERBODY FUSION L4-S1. LEGACY POSTERIOR INSTRUMENTATION, LOCAL BONE DBM AND "OSTEOCONDUCTIVE MOSAIC," PEEK SPACERS, SEASPINE ANTERIOR PLATES, AND RHBMP-2/ACS WERE USED. THE BMP, ALONG WITH DBM PUTTY, WAS PLACED WITHIN THE INTERBODY DEVICES AT L4-5 AND L5-S1. THERE WERE NO NOTED COMPLICATIONS. TWO HUNDRED SEVENTY-EIGHT DAYS POST-OP THE PATIENT PRESENTED FOR NCV/EMG TO RULE OUT CHRONIC RADICULITIS. TESTING INDICATED "ABNORMAL RIGHT LOWER EXTREMITY NCV/EMG STUDY. THERE IS ELECTRODIAGNOSTIC EVIDENCE OF A MOTOR AND SENSORY, AXONAL, LARGE FIBER POLYNEUROPATHY IN THE LOWER EXTREMITIES. THERE MAY BE A SUPERIMPOSED CHRONIC RIGHT L2-3 RADICULOPATHY. THERE IS NO ELECTRODIAGNOSTIC EVIDENCE OF AN ACUTE L4, L5-S1 RADICULOPATHY, OR MYOPATHY IN THE RIGHT LOWER EXTREMITY." TWO HUNDRED NINETY-EIGHT DAYS POST-OP A CT MYELOGRAM OF THE LUMBAR SPINE INDICATED "THERE IS TRANSITIONAL LUMBOSACRAL ANATOMY" STATUS POST POSTERIOR LUMBAR SPINAL FUSION FROM L1 THROUGH L5 WITH POSTERIOR DECOMPRESSION. THERE IS NO EVIDENCE OF HARDWARE COMPLICATION. THE POSTEROLATERAL BONE GRAFT APPEARS SOLIDLY UNITED FROM L1 THROUGH L5. MULTIFOCAL NEURAL FORAMINAL STENOSIS IS SEEN, AS DESCRIBED ABOVE. NO CENTRAL CANAL STENOSIS. MODERATE LEFT LATERAL RECESS STENOSIS IS SEEN AT L4/L5." THREE HUNDRED EIGHT DAYS POST-OP THE PATIENT PRESENTED WITH ONGOING RIGHT LEG RADICULOPATHY IN THE ANTERIOR TIB AS WELL AS A BURNING IN THE RIGHT LA TERAL SIDE OF HIS FOOT. THREE HUNDRED FORTY-THREE DAYS POST-OP THE PHYSICIAN'S NOTES STATE "A CT SCAN AND SCOLIOSIS X-RAYS WERE ALL EXAMINED, HIS IMPLANTS APPEAR TO BE IN GOOD POSITION WITH EVIDENCE OF PRETTY SOLID UNION ESPECIALLY POSTEROLATERALLY. AT L5-S1, THERE DOES APPEAR TO BE A SLIGHT RISK OF PSEUDOARTHROSIS. FOR ALL INTENTS AND PURPOSES, I AM CALLING THE LOWEST INSTRUMENTED VERTEBRA S1 AS THERE IS SOME QUESTION WHETHER HE HAS A SACRALIZED L5. FURTHERMORE, THE CT SCAN DOES CONFIRM SEVERE BILATERAL FORAMINAL STENOSIS AT L5-S1 AND L4-L5 WITH LATERAL RECESS STENOSIS PREDOMINANTLY AT L4-L5. OTHERWISE, THE BONY FUSION DOES APPEAR TO BE INTACT AND VERY SOLID ABOVE THESE LEVELS. ALSO OF NOTE IS THE ADJACENT SEGMENT DISEASE AT L1-L2 WITH SOME COLLAPSE AND OBVIOUS DEGENERATION." THREE HUNDRED SEVENTY-SEVEN DAYS POST-OP THE PATIENT PRESENTED FOR FOLLOW UP. PER THE PHYSICIAN'S NOTES, "HE STILL HAS PERSISTENT PAIN. THE INJECTION DID NOT HELP VERY MUCH" HE REMAINS TO HAVE SOME NUMBNESS AND TINGLING AND DYSESTHESIAS IN THE RIGHT ANTERIOR THIGH PREDOMINANTLY WITH SYMPTOMS EXTENDING DOWN THE L4 AND L5 DISTRIBUTION ON THE RIGHT AS WELL." FOUR HUNDRED NINETY-EIGHT DAYS POST-OP A CT SCAN OF THE LUMBAR SPINE INDICATED "COMPARED TO STUDY PERFORMED ON (B)(6) 2010, THERE IS NO SIGNIFICANT INTERVAL CHANGE. PATIENT IS STATUS POST L1-L5 POSTERIOR AND ANTERIOR LUMBAR SPINAL FUSION WITHOUT EVIDENCE OF HARDWARE COMPLICATION. THE POSTEROLATERAL BONE GRAFT AND DISC SPACES APPEAR SOLIDLY UNITED. MULTIFOCAL NEURAL FORAMINAL STENOSIS IS STABLE." FIVE HUNDRED THIRTY-TWO DAYS POST-OP THE PATIENT PRESENTED WITH PERSISTENT BILATERAL LOWER EXTREMITY PAIN. PATIENT WAS DIAGNOSED WITH BILATERAL RIGHT GREATER THAN LEFT L4 AND L5 RADICULOPATHY, ADJACENT SEGMENT DISEASE AT L2-L1, AND MILD RIGHT HIP DEGENERATIVE JOINT DISEASE. FIVE HUNDRED FIFTY-EIGHT DAYS POST-OP A CT MYELOGRAM INDICATED "NO EVIDENCE OF HARDWARE COMPLICATION, THE POSTEROLATERAL BONE GRAFT IS SOLIDLY NOTED" L1/L2: MODERATE LEFT AND MILD RIGHT NEURAL FORAMINAL STENOSIS. L4/L5: MODERATE BILATERAL NEURAL FORAMINAL STENOSIS." SIX HUNDRED THIRTY-SIX DAYS POST-OP THE PATIENT UNDERWENT A BILATERAL LOWER EMG. TEST RESULTS INDICATED "THERE IS ELECTRODIAGNOSTIC EVIDENCE OF AN AXONAL PROCESS AFFECTING MULTIPLE BILATERAL LUMBOSACRAL ROOTS AND NERVES WITH A DISTAL PREDOMINANCE. THESE FINDINGS ARE COMPATIBLE WITH AN AXONAL, LARGE FIBER, POLYNEUROPATHY IN THE BILATERAL LOWER EXTREMITIES. SUPERIMPOSED MULTILEVEL BILATERAL L4-S2 RADICULAR PROCESS IS NOT EXCLUDED." SEVEN HUNDRED THIRTY-TWO DAYS POST-OP THE PATIENT PRESENTED WITH PERSISTENT BILATERAL LOWER EXTREMITY PAIN RIGHT GREATER THAN LEFT. REVISION SURGERY DISCUSSED. SEVEN HUNDRED EIGHTY-TWO DAYS POST-OP THE PATIENT UNDERWENT A REVISION LAMINECTOMY AT L4, L5 AND S1. COMPLICATIONS INCLUDED A DURAL TEAR AT THE L5-S1 LEVEL, REQUIRING PRIMARY REPAIR. SEVEN HUNDRED EIGHTY-FOUR DAYS POST-OP THE PHYSICIAN'S CONSULTATION NOTES STATE "THE PATIENT" WAS FOUND TO HAVE A CREATININE OF 2.4 ON ROUTINE LABS TAKEN ON POSTOPERATIVE DAY #2. PER SURGEON, THERE WAS NO SIGNIFICANT COMPLICATIONS TO THE SURGERY" THE PATIENT DENIES ANY HISTORY OF CHRONIC KIDNEY DISEASE OR OBSTRUCTIVE UROPATHY" ACUTE KIDNEY INJURY. SUSPECT MAY BE SECONDARY TO PRERENAL AXOTEMIA VERSUS MILD ACUTE TUBULAR NECROSIS." A RENAL ULTRASOUND WAS NEGATIVE. SEVEN HUNDRED EIGHT-FIVE DAYS POST-OP THE PATIENT DEVELOPED EDEMA AND SWELLING OF THE LOWER EXTREMITIES. VENOUS PROFILE STUDY FOUND NORMAL MAJOR DEEP VEINS OF THE RIGHT AND LEFT LOWER EXTREMITY. EIGHT HUNDRED SIX DAYS POST-OP X-RAYS OF THE LUMBAR SPINE INDICATED "STABLE LUMBAR SPINE POSTERIOR FIXATION AND FUSION. SMALL GAS COLLECTION WITHIN THE SOFT TISSUES AT THE L3-L4 LEVEL." EIGHT HUNDRED NINE DAYS POST-OP THE PATIENT PRESENTED FOR FOLLOW UP. PER THE PHYSICIAN'S NOTES, "HE IS DOING VERY WELL. HE FEELS LIKE HE HAS A GOOD RECOVERY FROM HIS LEG STANDPOINT." NINE HUNDRED EIGHTY-EIGHT DAYS POST-OP AN X-RAY OF THE LUMBAR SPINE INDICATED "POSTOPERATIVE CHANGES AND MATURE LUMBAR FUSION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M110805AAA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |