BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTETRAK

    MDR report key: 3001494 · Received March 5, 2013

    Report

    Report Number
    1038671-2013-00014
    Event Type
    Other
    Date Received
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVAL OF RETURNED DEVICES PENDING.

    Description of Event or Problem · 1

    REVISION DUE TO PAIN. SURGEON NOTED WEAR ON INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93070 OPTETRAK TRAPEZOID TIBIAL TRAY HSH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention