BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE/LOK EXTERNAL FIXATION SYSTEM WIRE

    MDR report key: 1264642 · Received November 13, 2008

    Report

    Report Number
    2183449-2008-00011
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 13, 2008
    Manufacturer
    ORTHOFIX INC.
    Product Code
    DZK
    PMA / PMN Number
    K941048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AT THE USER FACILITY, THEREFORE EVALUATION BY THE MANUFACTURER IS NOT POSSIBLE.

    Description of Event or Problem · 1

    PROVIDED INFORMATION STATES THAT WIRE BREAKAGE WAS DETECTED 26 DAYS AFTER THE INITIAL PROCEDURE. PATIENT HAD A SECOND PROCEDURE TO REPLACE THE BROKEN WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUE/LOK EXTERNAL FIXATION SYSTEM WIRE FIXATION WIRE, 1.8MM X 400MM DZK ORTHOFIX INC. 54-1215 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention