BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER II EU

    MDR report key: 3002776 · Received March 13, 2013

    Report

    Report Number
    2953769-2013-00043
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    March 11, 2013
    Report Date
    April 10, 2013
    Manufacturer
    KYPHON NEUCHATEL
    Product Code
    HRX
    PMA / PMN Number
    N/A
    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.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT DURING FUNCTIONAL ANALYSIS A LOCKING SYRINGE WAS USED TO MAKE AN ATTEMPT TO INFLATE THE BALLOON. THE SYRINGE WAS FILLED WITH WATER AND CONNECTED TO THE IBT. NO SPECIFIC STRENGTH WAS NEEDED TO SEE THAT THE BALLOON HAS A LEAK. VISUAL ANALYSIS WAS PERFORMED ON THE BALLOON AND INDICATES THAT A HOLE WAS VISIBLE ON THE PROXIMAL PEAK OF THE BALLOON. BASED ON THE INFORMATION PROVIDED, FUNCTIONAL AND VISUAL ANALYSIS, THE MOST PROBABLE ROOT CAUSE OF THE LEAKAGE OF THE BALLOON IS ATTRIBUTED TO THE CONTACT WITH BONE SPLINTERS AND/OR SURGICAL TOOL DURING SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN BALLOON KYPHOPLASTY PROCEDURE, TWO BALLOONS RUPTURED AND CONTRAST DYE WAS LEAKED. NEW BALLOONS WERE USED TO COMPLETE THE PROCEDURE. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105031 KYPHON XPANDER II EU ARTHROSCOPE HRX KYPHON NEUCHATEL NEUCHATEL

    Patients

    Seq Age Sex Outcome Treatment
    1