BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT DEVICE (RHBMP-2)

    MDR report key: 3042691 · Received April 4, 2013

    Report

    Report Number
    MW5029642
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    December 16, 2009
    Report Date
    March 21, 2013
    Manufacturer
    MEDTRONIC INC
    Product Code
    NEK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD AN EXTREME INFLAMMATORY REACTION. I HAD LOOSENED SCREWS AND CRACKED SCREWS. THE FUSION DID NOT WORK. I STILL HAVE A LOOSE SCREW THAT NEEDS TO BE WATCHED. I HAD A REVISION SURGERY THAT WAS ABORTED DUE TO MY SPINE AND ESOPHAGUS BEING COMPLETELY STUCK TOGETHER. I MUST HAVE A LOOSE SCREW WATCHED BY X-RAY TO BE SURE IT IS NOT MOVING. I AM WORSE NOW THAN BEFORE MY INFUSE SURGERY. NOTHING CAN BE DONE TO CORRECT MY SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137984 INFUSE BONE GRAFT DEVICE (RHBMP-2) INFUSE NEK MEDTRONIC INC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R| S