BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER AEQUALIS REVERSED II

    MDR report key: 2190914 · Received July 19, 2011

    Report

    Report Number
    9610667-2011-00016
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    TORNIER
    Product Code
    KWS
    PMA / PMN Number
    K081059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    IMPLANT WOULD NOT LOCK INTO PLACE AFTER 45 MINUTES OF TRYING. SURGEON USED A CENTERED GLENOSPHERE TO COMPLETE THE SURGERY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER AEQUALIS REVERSED II 25MM GLENOID SPHERE 10 DEG TILTED 36MM KWS TORNIER 8665AI020

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR