BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    MDR report key: 2854895 · Received November 27, 2012

    Report

    Report Number
    MW5027793
    Event Type
    Injury
    Date Received
    November 27, 2012
    Date of Event
    August 18, 2009
    Report Date
    November 7, 2012
    Manufacturer
    MEDTRONIC, INC
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, 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 AND THE FEAR THAT I WILL HAVE TO UNDERGO ADD'L SURGERIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention