BEUDAMED
    FDA Adverse Event Summary report: N

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    MDR report key: 2840019 · Received November 15, 2012

    Report

    Report Number
    MW5027680
    Date Received
    November 15, 2012
    Date of Event
    March 6, 2008
    Report Date
    October 31, 2012
    Manufacturer
    MEDTORNIC, INC.
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE INFUSE IMPLANTED IN MY BACK DURING MY SURGERY. SINCE THEN I HAVE HAD EXTREME PAIN AND PHYSICAL DISCOMFORT AS WELL AS LIMITATIONS IN MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 MEDTORNIC INFUSE NEK MEDTORNIC, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention