BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    MDR report key: 2840031 · Received November 15, 2012

    Report

    Report Number
    MW5027696
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    February 22, 2010
    Report Date
    October 30, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE INFUSE IMPLANTED INSIDE OF MY BACK AND NOW SUFFER FROM SERIOUS PAIN AND PHYSICAL LIMITATIONS.

    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 47 YR Required Intervention