BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3830518 · Received May 23, 2014

    Report

    Report Number
    1030489-2014-02615
    Event Type
    Injury
    Date Received
    May 23, 2014
    Report Date
    May 1, 2014
    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): 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

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY (ACDF) SURGERY WHEREIN HIS SURGEON IMPLANTED RHBMP-2/ACS WITH A METAL CAGE DEVICE. THE PATIENT'S POST-OPERATIVE PERIOD WAS MARKED BY INCREASINGLY SEVERE PAIN. FOLLOWING THE SURGERY, PATIENT SUFFERED FROM AN AUTONOMIC NEUROPATHY, SMALL FIBER NEUROPATHY, PERIPHERAL NEUROPATHY, MUSCLE ATROPHY AND NERVE DAMAGE, EXTREME INFLAMMATORY REACTIONS, CHRONIC RADICULITIS, RETROGRADE EJACULATION, STERILITY, OSTEOLYSIS (BONE RESORPTION), DISPLACEMENT OR MIGRATION OF THE SPACER CAGE, PSEUDOARTHROSIS, DIFFICULTY SWALLOWING, DIFFICULTY BREATHING, DIFFICULTY GRIPPING AND HOLDING ITEMS, AND CHRONIC PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308586 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 Other