BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK TIBIAL INSERT, POSTERIOR STABILIZED

    MDR report key: 6157906 · Received December 9, 2016

    Report

    Report Number
    1038671-2016-00833
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    August 16, 2016
    Report Date
    December 9, 2016
    Manufacturer
    EXACTECH, INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING DEVICE RETURN.

    Description of Event or Problem · 1

    REVISION DUE TO POSTERIOR STABILIZED BONE HAD BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812364 OPTETRAK TIBIAL INSERT, POSTERIOR STABILIZED TIBIAL INSERT, JWH EXACTECH, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention