BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON EXPRESS INFLATABLE BONE TAMP

    MDR report key: 6128641 · Received November 23, 2016

    Report

    Report Number
    MW5066334
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    November 22, 2016
    Report Date
    November 23, 2016
    Manufacturer
    KYPHON / MEDTRONIC
    Product Code
    HXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RT KYPHON BALLOON USED DURING KYPHOPLASTY. RIGHT BALLOON RUPTURED INSIDE THE PT'S VERTEBRAE. UNABLE TO RETRIEVE THE BALLOON THROUGH THE CANNULA AND PIECE OF BALLOON LEFT BEHIND IN VERTEBRAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776863 KYPHON EXPRESS INFLATABLE BONE TAMP INFLATABLE BONE TAMP HXG KYPHON / MEDTRONIC KE202 0007638668

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR