BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3442921 · Received November 1, 2013

    Report

    Report Number
    1030489-2013-04360
    Event Type
    Injury
    Date Received
    November 1, 2013
    Report Date
    May 5, 2016
    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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2008 THE PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION AND POSTEROLATERAL SURGERY FROM L5 TO L5 USING RHBMP-2/ACS. THE PATIENT'S POST-OPERATIVE PERIOD WAS MARKED WITH INCREASINGLY SEVERE PAIN, TINGLING, AND NUMBNESS, MARKED BY PERIODS OF NEUROLOGIC DEFICIT, WHICH CAUSES HIM TO COLLAPSE. ON (B)(6) 2009, 63 WEEKS AFTER THE INITIAL SURGERY USING RHBMP-2/ACS, THE PATIENT HAD TO UNDERGO A REVISION SURGERY. POST-OPERATIVELY SINCE THE REVISION, THE PATIENT CONTINUES TO SUFFER SIGNIFICANT PAIN AND NEUROLOGIC DEFICIT WHEREBY HIS LEGS CANNOT RELIABLY SUPPORT HIM. POST-OPERATIVE IMAGING STUDIES ON (B)(6) 2008 REPORTEDLY REVEALS SUBSIDENCE OF THE INTERBODY GRAFT THAT IMPINGES ON THE EXITING NERVE ROOT AT THE LOCATION WHERE THE PATIENT WAS EXPOSED TO RHBMP-2/ACS. AN AGGRESSIVE INFLAMMATORY RESPONSE TO RHBMP-2/ACS CAUSES THE GRAFT TO SINK, EFFECTIVELY CRUSHING THE NERVES THAT EXIT THE SPINE. THIS NERVE DAMAGE WAS NOT VISIBLE ON THE PRE-OPERATIVE IMAGING STUDY ON (B)(6) 2008. A LUMBER CT STUDY DONE ON (B)(6) 2008 REPORTEDLY REVEALS GASEOUS DEGENERATION OF THE L4-5 DISC WITH A MODERATE BULGING DISC MARGIN AND ASYMMETRIC RIGHT POSTEROLATERAL DISC PROTRUSION WITH OVERALL MILD CENTRAL STENOSIS. THIS DEGENERATION IS A CONSEQUENCE OF A DELAYED-ONSET INFECTION, AN ESCALATION OF THE IMMUNE SYSTEM'S REJECTION OF THE RHBMP-2/ACS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON, (B)(6) 2008, PATIENT UNDERWENT FOLLOWING PROCEDURE: REDO LAMINECTOMY, RIGHT L4-5 WITH FORAMINOTOMY; RIGHT L4 NEUROLYSIS; LAMINECTOMIES LEFT L4-5; POSTERIOR INTERBODY FUSION L4-5; POSTEROLATERAL FUSION L4-5; INSERTION OF SMALL RHBMP-2/ACS BONE GRAFT; INSERTION OF ALLOGRAFT CANCELLOUS BONE CHIPS; INSERTION OF MOZAIK BONE GRAFT FROM INTEGRA; INSERTION OF AUTOGRAFT BONE FROM DECOMPRESSION; INSERTION OF INCOMPASS SPINAL INSTRUMENTATION FROM ABBOTT SPINE; FOR PRE-OP DIAGNOSIS OF: RIGHT LUMBAR RADICULOPATHY; FORAMINAL STENOSIS, RIGHT L4-5; ROTATIONAL INSTABILITY RIGHT L4-5; STATUS POST LAMINECTOMY RIGHT L4-5 X2; POST-OP DIAGNOSIS OF: RIGHT LUMBAR RADICULOPATHY; FORAMINAL STENOSIS, RIGHT L4-5; ROTATIONAL INSTABILITY RIGHT L4-5; STATUS POST LAMINECTOMY RIGHT L4-5 X2; SEVERE ADHESIONS RIHT L4-5; SIGNIFICANT ROTATIONAL INSTABILITY RIGHT L4-5. PER-OP NOTES: ¿ I DECORTICATED THE ENDPLATES. I THEN OBTAINED AN APPROPRIATE SIZED TRICORTICAL ALLOGRAFT PROSTHESIS. THIS WAS FURTHER CONTOURED INTO 2 SECTIONS. I THEN DID THE INTERBODY FUSION. ANTERIORLY, I PLACED RHBMP-2/ACS BONE GRAFT, ALLOGRAFT CHIPS, AND MOZAIK BONE GRAFT. I THEN PLACED 2 TRICORTICAL ALLOGRAFT PROSTHESIS. AFTER IMPACTION, I PLACED FURTHER AUTOGRAFT AND ALLOGERAFT BONE. THE DISTRACTION WAS RELEASED AND THE PROSTHESIS WERE NICELY COMPRESSED. THEY WERE STABLE. I DID TRY TO REDUCE PART OF THE ROTATIONAL DEFORMITY. I PLACED AN APPROPRIATE SIZED ROD BETWEEN THE SCREWS ON THE RIGHT SIDE AND LOCKED THEM INTO POSITION. I THEN PLACED BONE SCREWS INTO THE PEDICLES OF THE LEFT L4 AND LEFT L5 IN A SIMILAR FASHION AS THE OPPOSITE SIDE. I DECORTICATED THE TRANSVERSE PROCESSES AT THE RIGHT L4 AND L5. I ALSO DECORTICATED THE LAMINA AND EXCISED THE FACET JOINT. A POSTEROLATERAL FUSION PERFORMED, LEFT L4-5. I PLACED RHBMP-2/ACS BONE GRAFT, ALLOGRAFT CHIPS, AUTOGRAFT BONE AND MOZAIK BONE GRAFT.¿ ON (B)(6) 2008 THE PATIENT UNDERWENT X RAYS OF THE LUMBAR SPINE. FINDINGS: (0740 HRS) THERE IS A SINGLE SURGICAL CLAMP POSITIONED OVER THE POSTERIOR ELEMENTS OF THE LOWER LUMBAR SPINE WITH THE TIP JUST INFERIOR TO THE AXIAL PLANE OD THE L4-5 DISC SPACE. AT (1118HRS) THERE IS NOW NOTED PEDICLE SCREWS AND POSTERIOR FIXATION AT THE L4-5 LEVEL. LUMBAR ALIGNMENT APPEARS SATISFACTORY AND THERE DOES APPEAR TO BE INTERVERTEBRAL DISC MATERIAL OR PROSTHESIS, ALTHOUGH THIS IS PARTIALLY OBSCURED BY OVERLYING SURGICAL HARDWARE AND DENSITY. ON (B)(6) 2008 THE PATIENT WAS PRESENTED FOR OFFICE VISIT. THE PATIENT HAD LEFT LEG SYMPTOMS EARLY POST-OPERATIVELY. THESE HAVE NOT IMPROVED. ON (B)(6) 2008 THE PATIENT WAS PRESENTED FOR OFFICE VISIT TO EVALUATE LEFT SIDED LEG PAIN. ON (B)(6) 2008, PATIENT UNDERWENT FOLLOWING PROCEDURE: HARDWARE REMOVAL AT L4-5; REDO LAMINECTOMY L4-5 WITH FORAMINOTOMY; REINSERTION OF HARDWARE AT L4-5 (TRANSVERSE CONNECTOR); FOR PRE-OP AND POST-OP DIAGNOSIS OF: LEFT LUMBAR RADICULOPATHY; LEFT L4-5 FORAMINAL STENOSIS; STATUS POST POSTERIOR INTERBODY FUSION, L4-5. NO COMPLICATIONS WERE REPORTED. ON (B)(6) 2008, PATIENT UNDERWENT MRI OF LUMBAR SPINE WITHOUT CONTRAST. IMPRESSION: NO SIGNIFICANT INTERVAL CHANGES; STATUS POST LAMINECTOMY, DISCECTOMY AND FORAMINOTOMY AT L4-5, IN ANATOMIC ALIGNMENT, WITHOUT EVIDENCE OF DISCITIS, OSTEOMYELITIS, ARCHNOIDITIS, OR EPIDURAL ABSCESS FORMATION; MODERATE LEFT NEURAL FORAMINAL STENOSIS AT L4-5; POST SURGICAL SCAR/ OR VASCULAR TISSUE AT THE L4-5 LEVEL, AND IN THE NEURAL FORAMEN ON THE RIGHT MORE THAN THE LEFT, AND POSSIBLE ENCASING THE L4 AND L5 NERVE ROOTS. ON (B)(6) 2008 THE PATIENT WAS PRESENTED FOR OFFICE VISIT FOR POST-OP 13 DAY FOLLOW UP. NO COMPLICATION WAS REPORTED. ON (B)(6) 2008 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH RIGHT LEG PAIN EXTENDING INTO HIPS. HE CONTINUES TO HAVE THE LEFT LEG SYMPTOMS ALSO. ON (B)(6) 2008, PATIENT UNDERWENT LIMITED CT SCAN OF LUMBAR SPINE AT L4-5 DUE TO BILATERAL LEG PAIN AND BACK PAIN. CONCLUSION: SOLID APPEARING INTERBODY FUSION AT L4-5 WITH EVIDENCE OF HEALING POSTERIORLY ON THE LEFT; TRANSPEDICLE SCREW AND POSTERIOR ROD INSTRUMENTATION AT L4-5 IS PROJECTED IN GOOD POSITION AND NO HARDWARE FATIGUE IS SEEN; MILD SPONDYLOSIS AT L5-S1 AND L3-4 WITH NO FACET ARTHROPATHY AND NO STENOSIS OR IMPINGEMENT; MILD SECONDARY DEGENERATIVE CHANGES WITHIN THE SACROILIAC JOINTS; COMPARISON WITH CT OF (B)(6) 2008 SHOWS THAT FUSION AT L4-5 IS NEW IN THE INTERVAL. PATIENT UNDERWENT CT SCAN OF LUMBAR SPINE DUE TO SIX WEEKS OF LUMBAR RADICULOPATHY AND TO EVALUATE L4-5. CONCLUSION: L4-5 GASEOUS DISC DEGENERATION WITH BULGING DISC AND ASYMMETRIC PROTRUSION TO THE RIGHT WITH MILD CENTRAL STENOSIS, AS WELL AS RIGHT SUB-ARTICULAR ENCROACHMENT; L4-5 FACET JOINTS ARE UNREMARKABLE, GANGLIA EXIT WITHOUT COMPRESSION; NO FRACTURES IDENTIFIED TO THE EXTENT IS VISUALIZED. ON (B)(6) 2008 THE PATIENT WAS PRESENTED FOR OFFICE VISIT FOR FOLLOW UP. NO COMPLICATION WAS REPORTED. ON (B)(6) 2009, PATIENT UNDERWENT BILATERAL L5-S1 FACET JOINT INJECTIONS. INDICATION: PREVIOUS LUMBAR FUSION WITH CONTINUED BILATERAL LOW BACK PAIN. CONCLUSION: BILATERAL L5-S1 FACET JOINT ARTHROPATHY AND THERAPEUTIC INJECTION WITH MORE DEGENERATED OR DIFFICULT RIGHT L5-S1 FACET JOINT NEEDLE PLACEMENT; 100% RELIEF OF BASELINE BACK PAIN ON LEFT AND 80% ON THE RIGHT, OVERALL RATED R1. ON (B)(6) 2009 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH BACK PAIN. THE PATIENT UNDERWENT X RAYS OF THE LUMBAR SPINE: THERE APPEARS TO BE LOSS OF BONE DENSITY IN THE INTERBODY GRAFT AT L4-5. ON (B)(6) 2009, PATIENT UNDERWENT CT LUMBAR SPINE POST FUSION. CONCLUSION: SOLID L4-5 ANTERIOR AND POSTERIOR FUSION WITH RECURRENT STENOSIS. NO INSTRUMENTED COMPLICATIONS; L5-S1 FACET JOINT TROPISM WITH NO HERNIATION WITH STENOSIS; THERE IS SLIGHT ANNULAR BULGING AT L3-4 WITHOUT STENOSIS OR NEURAL IMPINGEMENT. ON (B)(6) 2009, PATIENT UNDERWENT FOLLOWING PROCEDURE: REMOVAL OF HARDWARE AT L4-5; EXPLORATION OF FUSION MASS; FOR PRE-OP DIAGNOSIS OF: PAINFUL HARDWARE, STATUS POST LUMBAR FUSION, L4-5; AND POST-OP DIAGNOSIS OF: PAINFUL HARDWARE, STATUS POST LUMBAR FUSION, L4-5, SOLID FUSION. NO COMPLICATIONS WERE REPORTED. ON (B)(6) 2009 THE PATIENT WAS PRESENTED FOR OFFICE VISIT. EXAMINATION: HIS LUMBAR INCISION IS CLEAN, DRY AND INTACT. THERE IS NO TENDERNESS TO PALPATION, ECCHYMOSIS, OR ERYTHEMA AROUND THE INCISION SITE. ON (B)(6) 2014, PATIENT PRESENTED FOR OFFICE VISIT WITH SEVERE BACK PAIN AND RIGHT LOWER EXTREMITY RADICULOPATHY. ON (B)(6) 2014, PATIENT UNDERWENT LUMBAR MYELOGRAM INJECTION. NO COMPLICATIONS WERE REPORTED. ON (B)(6) 2014, PATIENT UNDERWENT CT LUMBAR MYELOGRAM DUE TO LOW BACK PAIN AND RIGHT LOWER EXTREMITY RADICULOPATHY. IMPRESSION: POST OPERATIVE FINDINGS AT THE LOWER LUMBAR SPINE SIMILAR IN APPEARANCE TO PRIOR MRI. SOLID INTERBODY AND POSTERIOR BONY FUSIONS AT L4-5; MILD DEGENERATIVE DISC AND FACET DISEASE AT OTHER LEVELS. NO SIGNIFICANT NEURAL ENCROACHMENT IDENTIFIED. ON (B)(6) 2014, PATIENT PRESENTED FOR OFFICE VISIT FOR EVALUATION OF POSSIBLE PSEUDOMENINGOCELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563253 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