BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER II EU

    MDR report key: 3892444 · Received June 24, 2014

    Report

    Report Number
    2953769-2014-00076
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 23, 2014
    Report Date
    July 4, 2014
    Manufacturer
    KYPHON NEUCHATEL
    Product Code
    HRX
    PMA / PMN Number
    K101864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT THE IBT IS RECEIVED WITH THE OUTER SHAFT BENT. PRESENCE OF LIQUID IN THE BALLOON. DURING VISUAL ANALYSIS NO DAMAGE OR DEFECT WAS DETECTED. DURING FUNCTIONAL ANALYSIS, THE IBT WAS INFLATED TO THE MIV (MAXIMUM INFLATION VOLUME) OF 5CC WITH WATER WITHOUT PROBLEM. NO LEAK OR LOSS OF PRESSURE DETECTED ON THE INFORMATION PROVIDED, FUNCTIONAL AND VISUAL ANALYSIS, NO PROBLEM DETECTED ON THIS IBT.

    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 A PATIENT UNDERWENT AN UNKNOWN BALLOON KYPHOPLASTY PROCEDURE. DURING THE PROCEDURE, TWO BALLOONS WERE INSERTED INTO THE VERTEBRA AND INFLATED TO 250 PSI AND 2CC IN EACH BALLOON. BOTH BALLOONS RUPTURED DURING THE PROCEDURE. THE CONTRAST LIQUID LEAKED INTO THE VERTEBRA. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367810 KYPHON XPANDER II EU ARTHROSCOPE HRX KYPHON NEUCHATEL 0007095581

    Patients

    Seq Age Sex Outcome Treatment
    1