BEUDAMED
    FDA Adverse Event Other Summary report: N

    EQUINOXE

    MDR report key: 1892856 · Received November 3, 2010

    Report

    Report Number
    1038671-2010-00169
    Event Type
    Other
    Date Received
    November 3, 2010
    Date of Event
    August 18, 2010
    Report Date
    November 3, 2010
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEER EVALUATION PENDING.

    Description of Event or Problem · 1

    REVISION OF REVERSE SHOULDER COMPONENTS. REASON FOR OR DETAILS OF REVISION WERE NOT PROVIDED TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUINOXE REVERSE GLENOID PLATE KWT EXACTECH, INC. 30858002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention