BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    MDR report key: 2854856 · Received November 15, 2012

    Report

    Report Number
    MW5027774
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    July 2, 2004
    Report Date
    November 5, 2012
    Manufacturer
    MEDTRONIC, INC
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BECAUSE OF THE MEDTRONIC INFUSE IMPLANTED DURING MY SURGERY, I NOW SUFFER FROM SIGNIFICANT PAIN, MENTAL ANGUISH, AND THE FEAR OF NEEDING TO UNDERGO ANOTHER SURGERY.

    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 45 YR Required Intervention