BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE GLENOID PLATE

    MDR report key: 3981241 · Received July 24, 2014

    Report

    Report Number
    1038671-2014-00313
    Event Type
    Injury
    Date Received
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES ARE PENDING EVAL.

    Description of Event or Problem · 1

    REVISION OF SHOULDER COMPONENTS DUE TO GLENOSPHERE LOCKING SCREW FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435368 EQUINOXE REVERSE GLENOID PLATE REVERSE GLENOID PLATE KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization