BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS

    MDR report key: 3133922 · Received May 23, 2013

    Report

    Report Number
    9610667-2013-00136
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    June 3, 2012
    Report Date
    March 26, 2013
    Manufacturer
    TORNIER SAS
    Product Code
    KWS
    PMA / PMN Number
    K030941
    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, DISSOCIATION OF GLENOSPHERE FROM BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229977 AEQUALIS NONE KWS TORNIER SAS DWB950

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention