BEUDAMED
    FDA Adverse Event Summary report: N

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    MDR report key: 2915727 · Received January 10, 2013

    Report

    Report Number
    MW5028525
    Date Received
    January 10, 2013
    Date of Event
    May 12, 2010
    Report Date
    December 17, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BECAUSE OF THE INFUSE IMPLANTED DURING MY SURGERY I HAVE SUFFERED SERIOUS INJURY INCLUDING PAIN, PHYSICAL LIMITATIONS, THE NEED FOR A REVISION SURGERY, AS WELL AS THE CONSTANT FEAR I WILL NEVER BE WELL AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13942 MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 MEDTRONIC INFUSE NEK MEDTRONIC, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R