BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON INC.

    MDR report key: 559536 · Received November 17, 2004

    Report

    Report Number
    MW1033799
    Event Type
    Malfunction
    Date Received
    November 17, 2004
    Date of Event
    November 8, 2004
    Report Date
    November 8, 2004
    Manufacturer
    KYPHON INC.
    Product Code
    HXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    KYPHON INFLATION DEVICE BROKE OFF AFTER EXPANSION. A SMALL TIP WAS LEFT IN THE VERTEBRAL BODY OF T7.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 2/3/05: MFR WAS PREVIOUSLY UNAWARE OF THIS EVENT AND IS CURRENTLY EVALUATING WHETHER AN MDR REPORT FOR THIS EVENT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHON INC. KYPHX XPANDER INFLATABLE BONE TAMP HXG KYPHON INC. * J4071901

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other