BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE/LOK WIRE 1.8MM WIRE WITH CENTRAL OLIVE

    MDR report key: 1395556 · Received May 28, 2009

    Report

    Report Number
    2183449-2009-00011
    Event Type
    Injury
    Date Received
    May 28, 2009
    Date of Event
    April 22, 2009
    Report Date
    May 28, 2009
    Manufacturer
    ORTHOFIX INC.
    Product Code
    LXT
    PMA / PMN Number
    K941048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROVIDED INFORMATION STATES THAT DURING TREATMENT, 2 OF THE K-WIRES SNAPPED OFF AT THE FIXATION BOLT. PATIENT UNDERWENT A SECOND SURGERY TO REPLACE THE BROKEN WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUE/LOK WIRE 1.8MM WIRE WITH CENTRAL OLIVE TRUE/LOK K-WIRE LXT ORTHOFIX INC. 54-1215

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention