BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INFUSE

    MDR report key: 2820897 · Received October 31, 2012

    Report

    Report Number
    MW5027432
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    February 28, 2006
    Report Date
    October 31, 2012
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD MEDTRONIC INFUSE BONE GRAFT SURGERY. AFTER SOME TIME I HAVE OVERGROWN BONE WITH SIGNIFICANT CHRONIC BACK PAIN. I AM NOW 100% DEPENDENT ON A ROLLATOR WALKER AND CANNOT WALK ON MY OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INFUSE BONE GRAFT NEK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention