BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-WIRE

    MDR report key: 866741 · Received June 18, 2007

    Report

    Report Number
    2183449-2007-00009
    Event Type
    Malfunction
    Date Received
    June 18, 2007
    Date of Event
    May 2, 2007
    Report Date
    June 15, 2007
    Manufacturer
    ORTHOFIX INC.
    Product Code
    NDK
    PMA / PMN Number
    K941048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY 30 DAYS POST SURGERY DURING A FOLLOW UP VISIT, THE DOCTOR FOUND THAT TWO X-WIRES WERE BROKEN. THE WIRES WERE REMOVED FROM THE TREATMENT SITE AND DISCARDED IN THE DOCTOR'S OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-WIRE X-WIRE NDK ORTHOFIX INC. 80131 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR