BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    MDR report key: 3020777 · Received March 21, 2013

    Report

    Report Number
    MW5029456
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    July 31, 2006
    Report Date
    December 20, 2012
    Manufacturer
    MEDTRONIC, INC
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BECAUSE 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 HAVING TO UNDERGO A F/U SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117635 MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 MEDTRONIC INFUSE NEK MEDTRONIC, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention