BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3142588 · Received June 3, 2013

    Report

    Report Number
    1030489-2013-02056
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 7, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "I HAD A SPINAL FUSION DONE AT THE HOSPITAL. THEY FUSED MY 1-4/1-5 S-1 AND THEY USED BMP ALSO. MY SURGERY WAS DONE FROM THE BACK. NOT EVEN 3 MONTHS LATER, I WAS BACK IN THE HOSPITAL TO HAVE BONY OVERGROWTH REMOVED IN 2011. SINCE THEN I HAVE HAD HORRIBLE PAIN. EVEN HAD TO RESIGN FROM MY JOB. I ALSO HAD A SPINAL CORD STIMULATOR IMPLANTED, BUT NOTHING HAS WORKED. I HAVE JUST RECENTLY HEARD THAT BMP WAS ONLY SUPPOSED TO BE USED FOR BACK SURGERY DONE FROM THE FRONT, SO I'M UPSET BECAUSE I'M OLD, I HAVE HAD 4 MAJOR BACK SURGERIES AND NOW I HAVE THIS BMP IN ME THAT IS PUSHING ON MY NERVES CAUSING HORRIBLE PAIN TO MY LEGS AND BACK. I WILL BE HAVING ANOTHER SURGERY AT HOSPITAL TO HAVE THE BMP OVERGROWTH REMOVED OFF MY NERVES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243795 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