BEUDAMED
    FDA Adverse Event Injury Summary report: N

    (RHBMP-2) INFUSE BONE GRAFT DEVICE

    MDR report key: 3095997 · Received May 1, 2013

    Report

    Report Number
    MW5030034
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    November 3, 2007
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC INC
    Product Code
    NEC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A PLIF ON (B)(6) 2007, WHEN THEY USED INFUSE OFF LABEL FOR MY LS-SI SURGEON. I HAD A BONE GROWTH WHICH REQUIRED A REVISION SURGERY ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190279 (RHBMP-2) INFUSE BONE GRAFT DEVICE INFUSE NEC MEDTRONIC INC

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| O| R| S