BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS RESURFACING HEAD

    MDR report key: 6144238 · Received December 5, 2016

    Report

    Report Number
    3000931034-2016-00203
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 9, 2016
    Manufacturer
    TORNIER S.A.S.
    Product Code
    HSD
    UDI-DI
    03700386926938
    PMA / PMN Number
    K131231
    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 AT 8 YEARS POST-OPERATIVE FOR ROTATOR CUFF INSUFFICIENCY. CONVERSION INTO RSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796027 AEQUALIS RESURFACING HEAD HUMERAL RESURFACING HSD TORNIER S.A.S. 41X15 03700386926938

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other