BEUDAMED
    FDA Adverse Event Other Summary report: N

    EQUINOXE COMPRESSION SCREW/LOCKING CAP

    MDR report key: 3982663 · Received July 25, 2014

    Report

    Report Number
    1038671-2014-00318
    Event Type
    Other
    Date Received
    July 25, 2014
    Date of Event
    August 7, 2013
    Report Date
    July 24, 2014
    Manufacturer
    EXACTECH, INC.
    Product Code
    HWC
    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 EVALUATION. ADDITIONALLY, THE DEVICE SPECIFIC IDENTIFICATION INFO WAS NOT PROVIDED, PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD. DEVICES ORIGINALLY ASSOCIATED WITH 1038671-2014-00006.

    Description of Event or Problem · 1

    REVISION OF EQUINOXE SHOULDER COMPONENTS DUE TO LOSS OF FUNCTION. EVENT WAS DISCOVERED THROUGH EXACTECH CLINICAL RESEARCH. THE SURGEON DID NOT CONSIDER THIS EVENT TO BE DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436623 EQUINOXE COMPRESSION SCREW/LOCKING CAP COMPRESSION SCREW/LOCKING CAP HWC EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention