BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3161535 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02136
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NON-MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT A POSTERIOR FUSION USING RHBMP-2/ACS, AUTOGRAFT, DBM, OTHER IMPLANTS. 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) 2007: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH L5-S1 SPONDYLOLISTHESIS. LUMBAR RADICULAR SYNDROME. FAILED BACK SURGERY SYNDROME AND UNDERWENT THE FOLLOWING PROCEDURES: L5-S1 POSTERIOR SPINAL FUSION. L5-S1 SPINAL INSTRUMENTATION (CUSTOM SPINE ISSYS WITH 5.5 X 40 SCREW AT S1 ON THE RIGHT AND 5.5 X 40 SCREW AT L5 ON THE RIGHT. ILIAC CREST ASPIRATION X 3. ALLOGRAFT FOR SPINAL FUSION. L5 LAMINECTOMY. L4 PARTIAL LAMINECTOMY. S1 PARTIAL LAMINECTOMY. AS PER OP-NOTES, "SURGEONS PERFORMED ILIAC CREST ASPIRATION TIMES THREE FROM THE PATIENT'S ILIAC CREST. THIS WAS COMBINED WITH GRAFT AND LOCAL BONE. THEY ALSO HAD LEFT OVER BMP . SURGEONS CHOSE THE APPROPRIATELY SIZED ROD AND LOCKED IT INTO PLACE AT L5 AND S1 ON THE RIGHT SIDE. THE NUVASIVE IMPLANT WAS FILLED WITH BONE MORPHOGENIC PROTEIN. THE IMPLANT WAS TAPPED INTO PLACE AT THE L5-S1 LEVEL "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263235 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention