BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3086054 · Received April 30, 2013

    Report

    Report Number
    1030489-2013-01394
    Event Type
    Injury
    Date Received
    April 30, 2013
    Report Date
    May 17, 2018
    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)(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.

    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 THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: L5-S1 PSEUDO-ARTHROSIS WITH BROKEN S1 SCREW. POST L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION. PATIENT UNDERWENT FOLLOWING PROCEDURES: L5-S1 REVISION, LAMINOTOMY, FACETECTOMY, AND FOR LAMINECTOMY FOR THE PROCESS OF NEURAL DECOMPRESSION; EXPLORATION OF FUSION L5-S1; L5-S1 INSTRUMENTATION USING USS SYSTEM FROM SYNTHES AND L5-S1 POST LATERAL ARTHRODESIS USING AUTOGRAFT CRUSHED CANCELLOUS ALLOGRAFT DDX AND THE CHRONOS; LEFT ILIAC CREST BONE HARVESTING; REPAIR OF DURAL TEAR; USE OF INTRAOPERATIVE FLUOROSCOPY. AS PER OPERATIVE NOTES,¿ AFTER ADEQUATE EXPOSURE OF THE POSTERIOR SUPERIOR ILIAC SPINE OF THE LEFT SIDE, SURGEON USED CURVED OSTEOTOME, AS WELL AS BONE GOUACHES AND CURETTE TO HARVEST CORTICAL AS WELL AS CANCELLOUS BONE GRAFT. SURGEON DECIDED TO USE RHBMP-2/ACS TO HELP WITH THE FUSION DUE TO THE PSEUDO-ARTHROSIS NATURE OF THIS PROBLEM. SURGEON USED A SMALL SPONGE AND WE INSERTED EACH SPONGE IN THE LATERAL GUTTER BETWEEN L5 TRANSVERSE PROCESS AND THE SACRAL ALA. FOLLOWING THAT SURGEON USED THE AUTOGRAFT THAT WAS HARVESTED FROM THE ILIAC CREST THAT WAS MIXED WITH DBX AND THE CHRONOS AND INSERTED THIS MIXTURE INTO THE LATERAL GUTTER AND IMPACTED IT FIRMLY AGAINST THE TRANSVERSE PROCESS OF L5 AS WELL AS SACRAL ALA.¿ THE PATIENT PRESENTED WITH FOLLOWING POST-OP DIAGNOSIS: L5-S1 PSORIATIC ARTHRITIS ARTHROSIS WITH BROKEN S1 SCREW. POST L5-S1 TRANSFORAMINAL LUMBAR INTERBODY EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187226 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110806AAO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other