BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    MDR report key: 2915719 · Received January 9, 2013

    Report

    Report Number
    MW5028515
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    May 9, 2003
    Report Date
    December 13, 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 THAT WAS IMPLANTED DURING MY SPINAL SURGERY. BECAUSE OF THIS, I SUFFERED SERIOUS PAIN INCLUDING A REVISION SURGERY. I SUFFER FROM PHYSICAL LIMITATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12563 MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 MEDTRONIC INFUSE NEK MEDTRONIC, INC. UNK UNK
    12564 MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 MEDTRONIC INFUSE NEK MEDTRONIC, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R