BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMENDIA GUIDEWIRE

    MDR report key: 1963742 · Received January 12, 2011

    Report

    Report Number
    MW5019001
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 12, 2011
    Manufacturer
    AMENDIA, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A SPINAL SURGICAL PROCEDURE, A PORTION OF GUIDEWIRE BROKE WHILE IN THE PT'S BACK. APPROX 3/4 OF AN INCH OF GUIDEWIRE COULD NOT BE REMOVED AND REMAINS WITHIN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMENDIA GUIDEWIRE GUIDEWIRE DQX AMENDIA, INC. 9080-18U UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other