BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT DEVICE (RNBMPX)

    MDR report key: 3030378 · Received March 28, 2013

    Report

    Report Number
    MW5029552
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    July 29, 2009
    Report Date
    March 15, 2013
    Manufacturer
    MEDTRONIC INC.
    Product Code
    NEK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD UNCONTROLLED BONE GROWTH. I HAVE HAD ONE REVISION SURGERY. SUFFER FROM CHRONIC RADICULITIS. MY PAIN IS WORSE NOW THAN BEFORE MY SURGERY WITH INFUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127578 INFUSE BONE GRAFT DEVICE (RNBMPX) INFUSE NEK MEDTRONIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| O| R| S