BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPANDER IBT

    MDR report key: 3931767 · Received July 14, 2014

    Report

    Report Number
    2953769-2014-00094
    Event Type
    Malfunction
    Date Received
    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

    (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 DURING VISUAL ANALYSIS NO DAMAGE OR DEFECT WAS VISIBLE. 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.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: VCF IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING PROCEDURE THE BALLOON RUPTURED DURING INFLATION. PATIENT COMPLICATIONS WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410659 XPANDER IBT ARTHROSCOPE HRX KYPHON NEUCHATEL 0007006432

    Patients

    Seq Age Sex Outcome Treatment
    1