BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3161622 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02141
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    September 26, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NON-MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT A PROCEDURE FOR L4-S1 FUSION USING RHBMP-2/ACS WITH AUTOGRAFT AND ALLOGRAFT. SUBSEQUENTLY, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, PATIENT UNDERWENT THE FOLLOWING PROCEDURES: L4-5 AND L5-S1 LAMINECTOMIES FOR DECOMPRESSION OF THE SPINAL NERVE ROOTS; 14-5 AND L5-S1 POSTERIOR LUMBAR INTERBODY FUSION; USE OF PRE-MACHINED ALLOGRAFT INTERBODY SPACERS; LATERAL INTER-TRANSVERSE FUSION L4-5, L5·S1; SEGMENTAL INSTRUMENTATION USING LEGACY INSTRUMENTATION SYSTEM; HARVESTING OF LOCAL BONE GRAFT; USE OF BMP; USE AND INTERPRETATION OF INTRAOPERATIVE FLUOROSCOPY; CONTINUOUS SSEP AND FREE RUNNING EMG EVOKED POTENTIALS; PERIOPERATIVE ANTIBIOTICS ORDERED TO BE GIVEN WITHIN 1 HOUR OF SKIN INCISION. PREOPERATIVE, POSTOPERATIVE DIAGNOSIS: PERSISTENT LOW BACK PAIN WITH LUMBAR DEGENERATIVE DISC DISEASE, LUMBAR FORAMINAL STENOSIS, LUMBAR RADICULOPATHY. PER OP-NOTES: ¿ .. SURGEON THEN MOVED OVER TO THE RIGHT AND PACKED THE DISC SPACE WITH ONE-THIRD OF A BMP SPONGE WRAPPED AROUND SOME LOCALLY HARVESTED ALLOGRAFT. SURGEON THEN PACKED THE REMAINDER OF THE DISC SPACE WITH THE LOCALLY HARVESTED ALLOGRAFT. THEY THEN PLACED A SECOND 12 X 26 MM GRAFT, AND AGAIN USED FLUOROSCOPY AND APPROPRIATELY COUNTERSUNK IT. AFTER COMPLETING PLIF AT L5-S1, THEY WENT UP TO L4-5 AND ESSENTIALLY REPEATED THIS PROCEDURE, MOBILIZING THE L5 NERVE ROOTS BILATERALLY. DURING THIS PORTION OF THE PROCEDURE, SURGEON ACTUALLY HAD SOME SPONTANEOUS ACTIVATION OF THE CONTRALATERAL S1 NERVE ROOT. ¿ SURGEON THEN MOBILIZED THE L5 NERVE ROOTS BILATERALLY. SURGEON OPENED UP THE DISC SPACE AND AGAIN PROPERLY PREPARED THE DISC SPACE AS WE HAD AT L5-S1, AGAIN DISTRACTING UP TO 12 MM AND SELECTING 12 X 26 MM GRAFTS, AND PLACING THE GRAFTS BILATERALLY WITH THE CENTER PORTION OF THE DISC SPACE PACKED WITH ONE-THIRD OF A BMP SPONGE WITH BONE AND BONE BEHIND IT. THE BMP SPONGES AT BOTH LEVELS WERE KEPT ANTERIOR IN THE DISC SPACE. ...¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261848 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110811AAN

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention