BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    MDR report key: 2881683 · Received December 17, 2012

    Report

    Report Number
    MW5028231
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    May 17, 2006
    Report Date
    December 3, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE MEDTRONIC INFUSE IMPLANTED DURING MY SURGERY WHICH HAS CAUSED ME SIGNIFICANT PAIN, MAJOR RESPIRATORY PROBLEMS AND MENTAL ANGUISH.

    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 43 YR Required Intervention