BEUDAMED
    FDA Adverse Event Summary report: N

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    MDR report key: 2993174 · Received February 27, 2013

    Report

    Report Number
    MW5029206
    Date Received
    February 27, 2013
    Date of Event
    January 8, 2007
    Report Date
    December 11, 2012
    Manufacturer
    MEDTRONIC, 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

    I HAD THE INFUSE IMPLANTED DURING MY SPINAL SURGERY WHICH HAS CAUSED ME SIGNIFICANT PAIN AND MAJOR AS WELL AS A MENTAL ANGUISH. I'M WORRIED THINGS WILL GET WORSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83927 MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 MEDTRONIC INFUSE NEK MEDTRONIC, INC. UNK UNK
    83928 MEDTRONIC INFUSE BONE GRAFT OF RHBMP2 MEDTRONIC INFUSE NEK MEDTRONIC, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention| S