BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPANDER II EU

    MDR report key: 3477173 · Received November 19, 2013

    Report

    Report Number
    2953769-2013-00176
    Event Type
    Malfunction
    Date Received
    November 19, 2013
    Report Date
    October 22, 2013
    Manufacturer
    KYPHON NEUCHATEL
    Product Code
    KRX
    PMA / PMN Number
    K981251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS OF THE RETURNED ITEM SHOWS THAT DURING FUNCTIONAL ANALYSIS, AN ATTEMPT HAS BEEN DONE TO INFLATE THE BALLOON, BUT IT WAS NOT POSSIBLE, BECAUSE A LEAK APPEAR UNDER LOW PRESSURE. VISUAL ANALYSIS CONFIRMED THE LEAKAGE. A PIN HOLE HAS BEEN DISCOVER ON THE DISTAL PEAK OF THE BALLOON. NOTE THAT UNDER LOW PRESSURE, ONLY DROP COMES OUT FROM THIS HOLE AND IF THE PRESSURE IS HIGHER, A WATER SPRAY IS VISIBLE. BASED ON THE INFORMATION PROVIDED, FUNCTIONAL AND VISUAL ANALYSIS, THE MOST PROBABLE ROOT CAUSE OF THE LEAKAGE IS ATTRIBUTED TO THE CONTACT WITH BONE SPLINTERS DURING SURGERY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN BALLOON KYPHOPLASTY PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOO RUPTURED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600415 XPANDER II EU CALIBRATOR FOR CELL INDICES KRX KYPHON NEUCHATEL 0006855134

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR