BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHOPAK EXPRESS II TRAY FIRST FRACTURE

    MDR report key: 4251218 · Received November 4, 2014

    Report

    Report Number
    MW5039010
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    November 3, 2014
    Report Date
    November 4, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE KYPHON 15/2 KIT BALLOON ON THE LEFT SIDE RUPTURED AFTER 3 MINUTES OF INFLATION AT T9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706356 KYPHOPAK EXPRESS II TRAY FIRST FRACTURE KYPHOPLASTY CATHETER HRX MEDTRONIC SOFAMOR DANEK KYPHOPAK EXPRESS II TRAY FIRST F 0007294361

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention