BEUDAMED
    FDA Adverse Event Other Summary report: N

    KYPHON INC

    MDR report key: 762565 · Received September 19, 2006

    Report

    Report Number
    MW1040454
    Event Type
    Other
    Date Received
    September 19, 2006
    Date of Event
    September 13, 2006
    Report Date
    September 19, 2006
    Manufacturer
    KYPHON, INC
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING KYPHOPLASTY PROCEDURE BALLOON RUPTURED INSIDE LUMBAR 1 DISK LEAVING SMALL FRAGMENT OF DISTAL MARKER AT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHON INC BALLOON NDN KYPHON, INC REF KPT2005 J6081004

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other