BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS

    MDR report key: 3133961 · Received May 23, 2013

    Report

    Report Number
    9610667-2013-00131
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    July 7, 2011
    Report Date
    March 26, 2013
    Manufacturer
    TORNIER SAS
    Product Code
    KWS
    PMA / PMN Number
    K060209
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    POST OP, OTHER COMPLICATIONS, ASEPTIC HUMERAL LOOSENING WITH SUBSCAP FAILURE - REVISED TO REVERSE, IMPLANT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230038 AEQUALIS NONE KWS TORNIER SAS DWB216

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention