BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMERAL SEM, FRACTURE, 8MM

    MDR report key: 545920 · Received September 27, 2004

    Report

    Report Number
    1220246-2004-00102
    Event Type
    Other
    Date Received
    September 27, 2004
    Report Date
    September 24, 2004
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TRIAL SIZES OF THE IMPLANT WERE TESTED IN THE PT WITHOUT PROBLEMS, HOWEVER, WHEN INSERTING THE ACTUAL STEM, SURGEON ENCOUNTERED FITTING PROBLEMS. STEM WAS REMOVED AND A DIFFERENT BRAND IMPLANT WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS DELAYED 2 HOURS. THE DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMERAL SEM, FRACTURE, 8MM HUMERAL STEM (SHOULDER FRACTURE SYSTEM) KWS ARTHREX, INC. AR-9100-08F 02.130

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other