BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPANDER II

    MDR report key: 2940405 · Received February 3, 2013

    Report

    Report Number
    2953769-2013-00017
    Event Type
    Malfunction
    Date Received
    February 3, 2013
    Report Date
    February 25, 2013
    Manufacturer
    KYPHON NEUCHATEL
    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.

    Additional Manufacturer Narrative · 1

    FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE WAS NOT POSSIBLE, DUE TO THE PRESENCE OF A HOLE ON THE BALLOON. THE LEAKAGE ON THE BALLOON WAS TOO IMPORTANT TO PRESSURIZE EVENT VERY SLIGHTLY THE BALLOON. WATER QUANTITY INFUSED OR GIVEN PRESSURE VALUE IN THE BALLOON COULD NOT BE OBTAINED. VISUAL ANALYSIS CONFIRMED THE PRESENCE OF A RADIAL HOLE NEARBY THE DISTAL PEAK OF THE BALLOON. BASED ON THE INFORMATION PROVIDED, FUNCTIONAL AND VISUAL ANALYSIS, THE MOST PROBABLE ROOT CAUSE OF THE RUPTURE OF THE BALLOON IS ATTRIBUTED TO THE CONTACT WITH BONE SPLINTERS AND/OR SURGICAL TOOLS DURING SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN KYPHOPLASTY PROCEDURE, THAT THE BALLOON RUPTURED WHILE INFLATING IT. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45715 XPANDER II ARTHROSCOPE HRX KYPHON NEUCHATEL 0006172913

    Patients

    Seq Age Sex Outcome Treatment
    1