BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBT EXPRESS

    MDR report key: 3944944 · Received July 18, 2014

    Report

    Report Number
    2953769-2014-00097
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    July 14, 2014
    Report Date
    October 7, 2014
    Manufacturer
    KYPHON NEUCHATEL
    Product Code
    HRX
    PMA / PMN Number
    K041454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT DURING VISUAL ANALYSIS NO DAMAGE OR DEFECT WAS VISIBLE. BOTH MARKER ARE PRESENT IN THE BALLOON OF THE IBT AS USUAL. DURING FUNCTIONAL ANALYSIS IT WAS POSSIBLE TO INFLATE THE BALLOON UNTIL MIV (MAXIMUM INFLATION VOLUME) OF 4CC. NO HOLE OR LEAKAGE WAS VISIBLE AND NO UNCOMMON LOSS OF PRESSURE WAS VISIBLE. BASED ON THE INFORMATION PROVIDED, VISUAL AND FUNCTIONAL ANALYSIS THE BALLOON HAS NOT RUPTURED AND IS WORKING PROPERLY. THE COMPLAINT IS NOT CONFIRMED.

    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 THE SURGEON NOTICED THAT "SECOND X-RAY SIGN ON THE BALLOON WAS NOT ON THE BALLOON AND AFTER INFLATING THE BALLOON CONTRAST LIQUID RAN OUT." NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422000 IBT EXPRESS ARTHROSCOPE HRX KYPHON NEUCHATEL 0007081639

    Patients

    Seq Age Sex Outcome Treatment
    1