BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 1960244 · Received January 7, 2011

    Report

    Report Number
    1644408-2011-00006
    Event Type
    Other
    Date Received
    January 7, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - RSP FAILURE OF BASEPLATE, THE 3.5 MM CANCELLOUS SCREWS BROKE. THE GLENOSPHERE SEPARATED FROM THE BONE INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN UNKNOWN N/A ENCORE MEDICAL, L.P. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention