BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS REVERSED SHOULDER PROSTHESIS BASEPLATE LOCKING SCREWS

    MDR report key: 6084891 · Received November 8, 2016

    Report

    Report Number
    3000931034-2016-00186
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    August 31, 2016
    Report Date
    October 15, 2016
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR BREAKAGE OF TWO OF THE PERIPHERAL LOCKING SCREWS OF THE BASEPLATE DUE TO A FALL ONTO AN OUTSTRETCHED ARM. GLENOID SPHERE AND BASEPLATE WERE REMOVED AND REPLACED WITH NEW COMPONENTS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738608 AEQUALIS REVERSED SHOULDER PROSTHESIS BASEPLATE LOCKING SCREWS SHOULDER JOINT METAL PROSTHESIS KWS TORNIER S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other