BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER II EU

    MDR report key: 3892436 · Received June 24, 2014

    Report

    Report Number
    2953769-2014-00075
    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

    (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 THE IBT IS RECEIVED WITH THE OUTER SHAFT BENT. BLOOD IS VISIBLE ON THE DISTAL TIP OF THE BALLOON AND LIQUID IS PRESENT IN THE BALLOON. DURING FUNCTIONAL ANALYSIS, IT WAS NOT POSSIBLE TO INFLATE THE BALLOON DUE TO A HOLE IN IT. DURING VISUAL ANALYSIS, THE HOLE IS CONFIRMED. THIS IS A VERY SMALL HOLE NEARBY THE DISTAL PEAK OF THE BALLOON. NOTE THAT A LOT OF MARKS ARE VISIBLE ON THE BALLOON, PROBABLY DUE TO CONTACT WITH THE BONE. BASED ON THE INFORMATION PROVIDED, FUNCTIONAL AND VISUAL ANALYSIS, THE MOST PROBABLE ROOT CAUSE OF THE HOLE IN THE BALLOON IS DUE TO CONTACT WITH BONE SPLINTERS DURING SURGERY.

    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
    368027 KYPHON XPANDER II EU ARTHROSCOPE HRX KYPHON NEUCHATEL 0007095581

    Patients

    Seq Age Sex Outcome Treatment
    1