BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    MDR report key: 2915760 · Received January 10, 2013

    Report

    Report Number
    MW5028536
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    April 10, 2007
    Report Date
    December 13, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY SURGEON USED THE MEDTRONIC INFUSE WHICH CAUSED ME SIGNIFICANT PROBLEMS SUCH AS PAIN, REQUIRED ME TO UNDERGO A REVISION SURGERY, AND HAS ME CONSTANTLY WORRIED THAT THINGS WILL GET WORSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15887 MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 MEDTRONIC INFUSE NEK MEDTRONIC, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R