BEUDAMED
    FDA Adverse Event Other Summary report: N

    REVERSE SHOULDER SYSTEM

    MDR report key: 1202764 · Received October 13, 2008

    Report

    Report Number
    1644408-2008-00349
    Event Type
    Other
    Date Received
    October 13, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 20, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K041066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - DELTOID MUSCLE BELIEVED TO BE TOO TIGHT. CHANGED GLENOID HEAD FROM STANDART TO -4 (32MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVERSE SHOULDER SYSTEM GLENOID HEAD KWS ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention