BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTETRAK

    MDR report key: 3082785 · Received April 23, 2013

    Report

    Report Number
    1038671-2013-00026
    Event Type
    Other
    Date Received
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO THE PRODUCT MFR FOR EVAL. ADDITIONALLY, THE DEVICE INFO WAS NOT PROVIDED, PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.

    Description of Event or Problem · 1

    BILATERAL REVISIONS OF TIBIAL INSERTS FOR UNK REASONS. SURGEON COMMENTED THAT ONE OF THE REVISED INSERTS SHOWED NOTABLE WEAR. THIS EVENT OCCURRED OUTSIDE OF THE US, IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174806 OPTETRAK PS TIBIAL INSERT JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention