BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONCI INFUSE BONE GRAFT OR RHBMP2

    MDR report key: 2840037 · Received November 15, 2012

    Report

    Report Number
    MW5027690
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    May 6, 2011
    Report Date
    October 26, 2012
    Manufacturer
    MEDTORNIC, INC.
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BECAUSE OF THE MEDTRONIC INFUSE THAT WAS IMPLANTED INSIDE OF MY BACK, I BEGAN TO HAVE SERIOUS PROBLEMS. SOME OF THE PROBLEMS INCLUDE PAIN, MENTAL ANGUISH, OR THE FEAR THAT I WILL HAVE TO UNDERGO ADDITIONAL SURGERIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention