BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER II EU

    MDR report key: 3173721 · Received June 17, 2013

    Report

    Report Number
    2953769-2013-00087
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT 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 IS ATTRIBUTED TO THE CONTACT OF THE BALLOON WITH BONE SPLINTERS AND/OR SURGICAL TOOL 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. IT WAS REPORTED THAT DURING THE PROCEDURE, TWO BALLOONS RUPTURED DURING INFLATION. A NEW BALLOON WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273153 KYPHON XPANDER II EU ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG 0006625698

    Patients

    Seq Age Sex Outcome Treatment
    1