BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE HUMERAL HEAD, SHORT

    MDR report key: 6034223 · Received October 17, 2016

    Report

    Report Number
    1038671-2016-00688
    Event Type
    Injury
    Date Received
    October 17, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 17, 2016
    Manufacturer
    EXACTECH, INC
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    INDEX SURGERY (B)(6) 2012. REVISION OF CAGE GLENOID 4 YEARS POST-OP DUE TO SUBSCAP FAILURE AND GLENOID DISASSOCIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685151 EQUINOXE HUMERAL HEAD, SHORT HUMERAL HEAD KWS EXACTECH, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention