BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK TIBIAL TAMP

    MDR report key: 3736242 · Received April 3, 2014

    Report

    Report Number
    1038671-2014-00117
    Event Type
    Injury
    Date Received
    April 3, 2014
    Date of Event
    March 5, 2014
    Report Date
    April 3, 2014
    Manufacturer
    EXACTECH, INC.
    Product Code
    HXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVAL. ADDITIONALLY, THE DEVICE SPECIFIC IDENTIFICATION INFO WAS NOT PROVIDED, PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.

    Description of Event or Problem · 1

    FRACTURE ON THE ANTERIOR AND MEDIAL ASPECTS OF THE TIBIA DURING TEMPTING. THE SURGEON SUPPORTED THE PROCEDURE WITH A CANCELLOUS SCREW AND THEN PROCEEDED TO CEMENT AS NORMAL. THIS EVENT OCCURRED OUTSIDE THE UNITED STATES IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203330 OPTETRAK TIBIAL TAMP TIBIAL TAMP HXG EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R