INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2013-02065
- Event Type
- Injury
- Date Received
- June 3, 2013
- Report Date
- December 14, 2015
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- ATTORNEY
Narratives
(B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED 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.
(B)(4).
THE FOLLOWING IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. (B)(6) 2010 LUMBAR MRI. POSTOPERATIVE STUDY WITH INSTRUMENTATION FROM L3 TO S1. L3 PEDICLES APPEAR TO SHOW SIGNS OF PREVIOUS INSTRUMENTATION ALTHOUGH SCREWS ARE CURRENTLY ONLY IN L4, L5 AND S1. POSTOPERATIVE CHANGES ARE NOTED IN THE PARASPINOUS MUSCLES. APPARENT FLUID FILLED CYST SPANS FROM THE L3/4 DISC TO THE L5/S1 DISC AND COULD BE PLACING PRESSURE ON THE THECAL SAC AT THE L4 DISC LEVEL. GRADE ONE SPONDYLOLISTHESIS REMAINS AT THIS LEVEL. AXIAL VIEWS ARE OF VERY POOR QUALITY BUT APPEAR TO SUGGEST COMPRESSION OF THE THECAL SAC AT THE L4/5 LEVEL. SCREW POSITION IS GOOD. (B)(6) 2010. SINGLE AP VIEW OF CONSTRUCT FROM L3 TO THE SACRUM WITH CAPSTONE SPACERS. PEDICLES AT L3 HAVE HAD SCREWS BUT THEY HAVE BEEN REMOVED. CROSSLINK, RODS, SCREWS AND SPACER ARE IN ADEQUATE POSITION. (B)(6) 2010 LUMBAR MRI. SAGITTAL VIEWS STILL SHOW APPARENT CYST OR ENLARGEMENT OF THE THECAL SAC FROM L3 TO THE L5 DISC. AXIAL VIEWS APPEAR TO SHOW CLUMPING OF NERVE ROOTS CONSISTENT WITH ARACHNOIDITIS AS WELL AS POSSIBLE PSEUDO MENGIOCOELE FROM L3 TO L5. (B)(6) 2010. MRI LUMBAR SPINE WITH AND WITHOUT CONTRAST AGAIN EXTREMELY POOR DETAIL IN THIS STUDY. APPARENT FLUID COLLECTION HAS SUBSIDED CONSIDERABLY AND NO LONGER APPEARS TO BE COMPRESSING THE THECAL SAC. INSTRUMENTATION IS STILL IN GOOD POSITION. (B)(6) 2011 LUMBAR MRI. SWELLING HAS SUBSIDED FURTHER AND THE DURAL SAC IS AGAIN CLEARLY DEMARCATED, ALTHOUGH SLIGHTLY DILATED. ROOTS REMAIN CLUMPED. PROMINENT SCAR AND DISTORTION IS SEEN AROUND THECAL SAC AND DISC SPACES WHERE FUSION WAS PERFORMED.
IT WAS REPORTED THAT ON (B)(6) 2008, MRI OF THE LUMBAR SPINE INDICATED ¿STATUS POST L3-4 LAMINECTOMY AND POSTERIOR FUSION. L4-5 MILD TO MODERATE ACQUIRED CENTRAL SPINAL STENOSIS AND MILD TO MODERATE BILATERAL FORAMINAL STENOSIS.¿ (B)(6) 2010, CT LUMBAR MYELOGRAM INDICATED ¿BILATERAL, POSTERIOR L3-L4 BILATERAL FUSION RODS WITH TRANSPEDICULAR SCREWS AND BONE GRAFTING IS SEEN WITHOUT COMPLICATION. THERE IS GRADE 1 ANTEROLISTHESIS OF L4-L5 WITH ANTERIOR TRANSLATION OF APPROXIMATELY 7.8 MM. BILATERAL PARS ARTICULARIS FRACTURE AT L4 IS NOTICED. NO COMPRESSION DEFORMITY IDENTIFIED.¿ ON (B)(6) 2010, PATIENT PRESENTED WITH GRADE II L4-5 ISTHMIC SPONDYLOLISTHESIS, L4-S1 LUMBAR STENOSIS, L5-S1 DDD, L3-L4 RETAINED DEEP HARDWARE, AND LEFT LEG RADICULOPATHY. THE PATIENT UNDERWENT L4-S1 TLIF AND PSF USING POSTERIOR INSTRUMENTATION, INTERBODY DEVICES, AND RHBMP-2/ACS. INTRAOPERATIVELY, THERE WAS A SMALL DUROTOMY RESULTING IN A SMALL SPINAL FLUID LEAK. THIS WAS REPAIRED. THERE WERE NO OTHER NOTED COMPLICATIONS. (B)(6) 2010, MRI OF THE LUMBAR SPINE INDICATED ¿CYSTIC DEFECTS WITHIN THE RIGHT POSTERIOR LATERAL ASPECTS OF THE L4-L5 AND L5-S1 DISCS WITH MASS EFFECT.¿ ON (B)(6) 2010, THE PATIENT DEVELOPED AN EPIDURAL SEROMA RESULTING IN LUMBAR STENOSIS AND RIGHT LOWER EXTREMITY RADICULOPATHY. PATIENT UNDERWENT I<(>&<)>D SURGICAL PROCEDURE TO DRAIN THE SEROMA. PATIENT WAS DISCHARGED ON (B)(6) 2010. (B)(6) 2010, PATIENT PRESENTED WITH RIGHT LEG PAIN. AN MRI INDICATED ¿THERE IS A LOCULATED FLUID COLLECTION SUGGESTING A PSEUDOMENINGOCELE FILLING OF THE LAMINECTOMY SITE AND THE RIGHT LUMBAR SPINAL CANAL FROM L4 THROUGH S1 LEVELS. THIS PRODUCES A STENOSIS OF THE SPINAL CANALS AT THE POSTOPERATIVE SITE. THERE APPEARS TO BE A LEFT PARACENTRAL PROTRUSION OF THE L4-L5 DISC CONTRIBUTING TO THE STENOSIS. THERE IS MODERATE FORAMINAL STENOSIS BILATERALLY AT L4-5 AND L5-S1 AND THIS IS MOST PROMINENT TO THE LEFT AT L4-L5. THERE IS NO ENHANCING ABNORMALITY DEMONSTRATED AROUND THE FLUID COLLECTION OR IN THE BONY STRUCTURES.¿ ON (B)(6) 2010, THE PATIENT PRESENTED WITH CAUDA EQUINA SYNDROME, L4-S1 LUMBAR STENOSIS, RIGHT LEG RADICULOPATHY, AND WAS DIAGNOSED WITH A DEEP LUMBAR WOUND SEROMA. PATIENT UNDERWENT I<(>&<)>D SURGICAL PROCEDURE TO DRAIN THE SEROMA. (B)(6) 2010, AN MRI OF THE LUMBAR SPINE INDICATED ¿SIGNIFICANT INTERVAL DECREASE IN SIZE OF POSTOPERATIVE FLUID COLLECTION IN THE LAMINECTOMY SITE. MINIMAL RESIDUAL FLUID IS SEEN.¿ (B)(6) 2011 AN MRI OF THE LUMBAR SPINE INDICATED ¿¿ THERE IS SIGNIFICANT ENHANCING MATERIAL ABOUT THE THECAL SAC WHICH EXTENDS FROM THE L3-L4 DISC TO L5-S1 CONSISTENT WITH CONCENTRIC EPIDURAL FIBROSIS. SLIGHT PROGRESSIVE CLUMPING OF DISTAL NERVE ROOTS IN THE THECAL SAC CONSISTENT WITH ARACHNOIDITIS.¿ (B)(6) 2011 MRI INDICATED ¿DEGENERATIVE DISC DISEASE FROM L3-S1 WITH MILD RESIDUAL BILATERAL NEURAL FORAMINAL STENOSIS FROM L4-S1 ALTHOUGH EVALUATION IS LIMITED BY METAL ARTIFACTS. CLUMPED NERVE ROOTS FROM L34-S1 DISPLACED TO THE PERIPHERY OF THE THECAL SAC SUGGESTING ARACHNOIDITIS¿¿
IT WAS REPORTED THAT ON (B)(6) 2010 THE PATIENT UNDERWENT A POSTERIOR-APPROACH LUMBAR SPINE FUSION AT LEVELS L4-L5 AND L5-S1 USING RHBMP-2/ACS. THE PATIENT NOW SUFFERS FROM SEVERE INJURIES INCLUDING CAUDA EQUINA SYNDROME, MULTIPLE SEROMAS, UROLOGICAL PROBLEMS, BILATERAL NUMBNESS AND SEVERE PAIN IN THE LOWER EXTREMITIES, LEFT FOOT DROP, EMOTIONAL DISTRESS, AND MENTAL ANGUISH.
IT WAS REPORTED THAT ON (B)(6) 2010, PATIENT UNDERWENT FOLLOWING PROCEDURE: L4-L5, L5-S1 TRANSFORAMINAL LUMBAR BODY FUSION; L4-L5, L5-S1 POSTERIOR SPINAL FUSION; L4 TO S1 POSTERIOR INSTRUMENTATION; L4-L5, L5-S1 BILATERAL LAMINECTOMIES, FORAMINOTOMIES, AND PARTIAL MEDIAL FACETECTOMIES; L3-L4 HARDWARE REMOVAL, DEEP; L3-L4 FUSION EXPLORATION; LNTERBODY CAGES L4-L5, L5-S1; DURAL REPAIR REQUIRING LAMINECTOMY AND REQUIRING PATCH ALLOGRAFT OVERLAY; LOCAL AUTOGRAFT FOR SPINAL FUSION; ALLOGRAFT FOR SPINAL FUSION; FLUOROSCOPY FOR LOCALIZATION SPINAL PROCEDURE; FOR PRE-OP DIAGNOSIS OF: L4-L5 ISTHMIC SPONDYLOLISTHESIS, GRADE 2; L4-L5, L5-S1 LUMBAR STENOSIS; L5-S1 DEGENERATIVE DISK DISEASE; L3-L4 RETAINED DEEP HARDWARE; LEFT LEG RADLCULOPATHY; AND POST0-OP DIOAGNOSIS OF: L4-L5 ISTHMIC SPONDYLOLISTHESIS, GRADE 2; L4-L5, L5-S1 LUMBAR STENOSIS; L5-S1 DEGENERATIVE DISK DISEASE; L3-L4 RETAINED DEEP HARDWARE; LEFT LEG RADLCULOPATHY; INCIDENTAL DUROTOMY WITH SPINAL FLUID LEAK. PATIENT WITH L3-4 FUSION WHO HAS DEVE LOPED ADJACENT SEGMENT DEGENERATION AT THE L4-5 LEVEL WITH BILATERAL SPONDYLOLYSIS DEFECTS AND GRADE 2 SPONDYLOLISTHESIS WITH STENOSIS AND HAS ALSO DEVELOPED L5-S1 LUMBAR STENOSIS AND DEGENERATIVE DISK DISEASE. PER-OP NOTES: THE TRANSVERSE PROCESSES OF L4 AND LS WERE EXPOSED BILATERALLY AND THE SACRAL ALA. LEVELS WERE CONFIRMED WITH LATERAL FLUOROSCOPY INTRAOPERATIVELY AND THE L5 SPINOUS PROCESS MARKED WITH RONGEUR. L3-4 PEDICLE SCREW INSTRUMENTATION WAS REMOVED. THERE IS GOOD BILATERAL FUSION MASS PRESENT AND NO MOTION ON STRESSING OF THE CONSTRUCT. THE HARDWARE WAS REMOVED WITHOUT COMPLICATION. BILATERAL L5 AND S1 SCREWS WERE PLACED USING INTRAOPERATIVE X-RAY AND DIRECT PALPATION TECHNIQUE. USING A BLUNT PEDICLE PROBE, THEN SOUNDING THE PEDICLE WITH A BALL-TIP PROBE DEMONSTRATED NO BREACHES. TAPPING THE SCREW HOLES WITH A 5.5-MM TAP, AGAIN SOUNDING THE PEDICLES DEMONSTRATED NO BREACHES AND CONFIRMED OUR POSITION WITH AP LATERAL FLUOROSCOPY. USING THE 6.5-MM 45-MM SCREWS AT L5 BILATERALLY AND 6.5 X 40 MM SCREWS BILATERALLY AT S1, 6.5 X 45 MM SCREWS WERE PLACED BILATERALLY AT L4 THROUGH PREVIOUS SCREW HOLES. LAMINECTOMIES WERE COMPLETED AT L5 AND L4. AT. THE JUNCTION OF THE PREVIOUS LAMINECTOMY A LARGE AMOUNT OF SCAR TISSUE WAS STILL COMPRESSING THE LEFT SIDE DURAL SAC, AND THIS WAS DISSECTED FREE. DURING RESECTION OF THE SCAR TISSUE A SMALL DUROTOMY WAS MADE WITH A SMALL SPINAL FLUID LEAK. THE TISSUE AROUND THIS AREA WAS FRIABLE AND ON ATTEMPT FOR DIRECT REPAIR IT KEPT BREAKING DOWN. AT THIS TIME A PATCH WAS OPENED AND USED TO PATCH OVER THE FRIABLE TISSUE AND SEALED WITH A WATERTIGHT CLOSURE WITH A RUNNING BASEBALL-TYPE STITCH. BILATERAL FORAMINOTOMIES WERE COMPLETED AND THROUGH A RIGHT-SIDED APPROACH TRANSFORAMINAL LUMBAR INTERBODY FUSIONS WERE COMPLETED AT L4-5 AND L5-S1 USING NERVE ROOT RETRACTOR TO RETRACT THE NERVE SAC MEDIALLY AND DISSECTING AND CREATING A BOX ANNULOTOMY ON EACH DISK SPACE. AN 8-MM LORDOTIC SPACER WAS CHOSEN FOR THE L4-S1 LEVEL AND A 10-MM SPACER WAS CHOSEN FOR THE L5-S1 LEVEL. THE ANTERIOR DISK SPACES AT EACH LEVEL WERE PACKED ANTERIORLY WITH LOCAL AUTOGRAFT BONE, AND THEN 2 STRIPS OF BONE MORPHOGENIC PROTEIN WRAPPED IN BURRITO FASHION IN LOCAL AUTOGRAFT BONE WERE PACKED IN FRONT OF THE CAGE. THE CAGE WAS THEN PLACED OBLIQUELY ACROSS THE DISK SPACE WITH PACKED WITH LOCAL AUTOGRAFT BONE. THE POSTERIOR ASPECT OF THE DISK SPACE WAS PACKED WITH LOCAL AUTOGRAFT BONE ADDITIONALLY. THEIR POSITION WAS CONFIRMED ON AP AND LATERAL FLUOROSCOPY. THE 60 MM PRE-CONTOURED RODS WERE THEN PLACED OVER THE LONG POST AND NITINOL EXTENDERS FOR THE SYSTEM AND OVER THE SHORT POST SET. COMPRESSION WAS TAKEN ACROSS THE SCREW HEADS, AND FINAL TIGHTENING WAS THEN UNDERTAKEN. A CROSS-LINK WAS PLACED BETWEEN THE L4-5 LEVELS. FEELING WITH A BALL-TIP PROBE DEMONSTRATED ADEQUATE DECOMPRESSION OF THE BILATERAL NEURAL FORAMINA. L4, L5, AND SACRAL ALA WERE DECORTICATED, AND 2 STRIPS OF BONE MORPHOGENIC PROTEIN WERE WRAPPED IN BURRITOFASHION AND WERE PLACED IN THE LATERAL GUTTER, ONE EACH BETWEEN L4-5 AND L5-S1 TRANSVERSE PROCESSES ON THE LEFT SIDE. NO BONE MORPHOGENIC PROTEIN WAS USED ON THE RIGHT SIDE. LOCAL AUTOGRAFT BONE MIXED WITH ALLOGRAFT BONE WAS THEN PACKED IN THE LATERAL RECESSES. PATIENT RETURNED TO RECOVERY ROOM IN STABLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243244 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M110812AAM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |