BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON BALLOON

    MDR report key: 1840010 · Received September 15, 2010

    Report

    Report Number
    MW5017439
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 16, 2010
    Report Date
    September 15, 2010
    Manufacturer
    KYPHON, INC.
    Product Code
    OAR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A L5 KYPHOPLASTY, THE BALLOON BROKE ON THE RIGHT SIDE. APPROXIMATELY 2ML'S OF THE CONTRAST HAD LEAKED OUT. ALL OF THE BALLOON WAS REMOVED, THERE WAS NO REMAINING BALLOON ON THE RIGHT SIDE. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHON BALLOON KYPHON BALLOON OAR KYPHON, INC. 01480852

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other