BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER II EU

    MDR report key: 3844918 · Received June 3, 2014

    Report

    Report Number
    2953769-2014-00062
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    PMA / PMN Number
    K101864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN BALLOON KYPHOPLASTY PROCEDURE AT L1. IT WAS REPORTED THAT THE BALLOON RUPTURED AT 500 PSI DURING INSERTION. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325002 KYPHON XPANDER II EU ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR