BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUELOK RING FIXATION SYSTEM

    MDR report key: 2432583 · Received January 20, 2012

    Report

    Report Number
    3008524126-2011-00046
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    November 23, 2011
    Report Date
    January 19, 2012
    Manufacturer
    ORTHOFIX INC.
    Product Code
    LXT
    PMA / PMN Number
    K941048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INFO PROVIDED STATES THAT THREE (3) OF THE OLIVE WIRES ON THE TRUELOK FRAME BROKE AFTER PT BECAME WEIGHT BEARING AND HAD TO BE REPLACED ON (B)(6) 2011. TRUELOK FRAME WAS REMOVED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUELOK RING FIXATION SYSTEM TRUELOK BAYONET WIRE W/ STOPPER LXT ORTHOFIX INC. 54-1215 (3)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other