BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS REVERSED HUMERAL SPACER 36MM

    MDR report key: 4963100 · Received July 31, 2015

    Report

    Report Number
    3000931034-2015-00129
    Event Type
    Injury
    Date Received
    July 31, 2015
    Date of Event
    June 8, 2015
    Report Date
    July 3, 2015
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    PMA / PMN Number
    K030941
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFECTION AFTER THE SURGERY. (B)(6) WAS DETECTED. AND SPACER, INSERT AND GLENOID SPHERE WERE CHANGED BY THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498992 AEQUALIS REVERSED HUMERAL SPACER 36MM NONE KWS TORNIER S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other