BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT DEVICE

    MDR report key: 3050275 · Received April 5, 2013

    Report

    Report Number
    MW5029684
    Event Type
    Injury
    Date Received
    April 5, 2013
    Date of Event
    September 25, 2009
    Report Date
    March 1, 2013
    Manufacturer
    MEDTRONIC INC
    Product Code
    NEK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    POST-SURGICAL SYMPTOMS, CHRONIC FOOT DROP, LEFT LEG/HIP PAIN, DID NOT HAVE ANY LEG PROBLEMS PRIOR TO BACK FUSION. MOBILITY VERY LIMITED. POST- SURGICAL. PERMANENT BONE GROWTH ON SYMPATHETIC CHAIN OF LOWER BACK POST FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139888 INFUSE BONE GRAFT DEVICE INFUSE NEK MEDTRONIC INC

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R| S