BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    MDR report key: 2840049 · Received November 15, 2012

    Report

    Report Number
    MW5027698
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    January 20, 2009
    Report Date
    October 30, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SINCE MY SURGEON USED THE MEDTRONIC INFUSE IN MY BACK SURGERY, I HAVE EXPERIENCED SEVERE PAIN AND IT HAS REQUIRED ME TO SEE MY DOCTOR SEVERAL TIMES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention