BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTETRAK

    MDR report key: 1892853 · Received November 3, 2010

    Report

    Report Number
    1038671-2010-00166
    Event Type
    Other
    Date Received
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATION OF THE RETURNED TIBIAL INSERT NOTED DEFORMATION OF THE ANTERIOR SLOT AND LEFT ANTERIOR EDGE OF THE CONDYLE CONSISTENT WITH DEVICE EXTRACTION.

    Description of Event or Problem · 1

    REVISION DUE TO TIBIAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTETRAK TIBIAL INSERT JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention