BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 1972265 · Received January 20, 2011

    Report

    Report Number
    1038671-2011-00010
    Event Type
    Injury
    Date Received
    January 20, 2011
    Report Date
    January 20, 2010
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED IN PT.

    Description of Event or Problem · 1

    SURGEON NOTED FEMORAL BONE CRACK ON POST OPERATIVE X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTETRAK LOGIC FEMORAL COMPONENT JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other