BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    MDR report key: 2941305 · Received January 29, 2013

    Report

    Report Number
    MW5028799
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    October 7, 2009
    Report Date
    January 21, 2013
    Manufacturer
    MEDTRONIC, INC
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, 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 PROBLEMS INCLUDE PAIN, MENTAL ANGUISH AND THE FEAR THAT I WILL HAVE TO UNDERGO ADD'L SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38977 MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 MEDTRONIC INFUSE NEK MEDTRONIC, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention