BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXACTECH EQUINOXE

    MDR report key: 2149461 · Received June 24, 2011

    Report

    Report Number
    1038671-2011-00063
    Event Type
    Other
    Date Received
    June 24, 2011
    Date of Event
    May 11, 2011
    Report Date
    June 24, 2011
    Manufacturer
    EXACTECH, INC.
    Product Code
    DZL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW PROVIDES ASSURANCE THE PART WAS ACCEPTED WITH CONFORMANCE TO THE PRODUCT REQUIREMENTS. RETURNED DEVICES ARE CURRENTLY UNDERGOING ENGINEERING EVAL.

    Description of Event or Problem · 1

    SHOULDER COMPONENTS WERE REVISED 1 YEAR AND 10 MONTHS POST OPERATIVELY AFTER THE HUMERAL BASEPLATE REPORTEDLY DISASSOCIATED FROM THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTECH EQUINOXE REVERSE TORQUE DEFINING SCREW KIT DZL EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention