BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPANDER II IBT

    MDR report key: 3230025 · Received July 16, 2013

    Report

    Report Number
    2953769-2013-00105
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    July 10, 2013
    Report Date
    August 2, 2013
    Manufacturer
    KYPHON NEUCHATEL
    Product Code
    HRX
    PMA / PMN Number
    K101864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT DURING FUNCTIONAL ANALYSIS, IT WAS NOT MORE POSSIBLE TO INFLATE THE BALLOON DUE TO A LARGE HOLE IN IT. VISUAL ANALYSIS CONFIRMED THE HOLE IN THE BALLOON. THIS HOLE IS A RADIAL RUPTURE OF THE DISTAL LOB 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 CONTACT WITH BONE SPLINTERS AND/OR SURGICAL TOOLS DURING SURGERY.

    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 KYPHOPLASTY PROCEDURE. DURING THE PROCEDURE, TWO BALLOONS RUPTURED. AFTER THE BALLOONS RUPTURED, THE SURGEON HAD TO SWITCH TO A VERTEBROPLASTY PROCEDURE. THE PATIENT IS SAID TO BE OK. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328367 XPANDER II IBT ARTHROSCOPE HRX KYPHON NEUCHATEL 0006653066

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR