BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUS SL

    MDR report key: 1040197 · Received May 8, 2008

    Report

    Report Number
    9612771-2008-00025
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 15, 2008
    Report Date
    May 8, 2008
    Manufacturer
    PLUS ORTHOPEDICS AG
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUS SL STEM KWY PLUS ORTHOPEDICS AG NA 0410.13.3150

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R