BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER II EU

    MDR report key: 3931618 · Received July 14, 2014

    Report

    Report Number
    2953769-2014-00091
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    October 6, 2014
    Manufacturer
    KYPHON NEUCHATEL
    Product Code
    HRX
    PMA / PMN Number
    K101864
    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 PROBLEM WAS DETECTED. THE SHAPE OF THE BALLOON INDICATES THAT IT HAS BEEN INFLATED AT LEAST ONE TIME UNDER RELATIVELY HIGH PRESSURE. DURING FUNCTIONAL ANALYSIS IT WAS NOT MORE POSSIBLE TO INFLATE THE BALLOON DUE TO A HOLE IN IT. THE HOLE WAS LOCATED NEARBY THE DISTAL PEAK OF THE BALLOON. BASED ON THE INFORMATION PROVIDED, VISUAL AND FUNCTIONAL ANALYSIS THE MOST PROBABLE ROOT CAUSE OF THE RUPTURE IS ATTRIBUTED TO THE CONTACT OF THE BALLOON WITH SHARP TOOL OR BONE SPLINTERS 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 BALLOON KYPHOPLASTY PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOONS RUPTURED WHILE INFLATING. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410834 KYPHON XPANDER II EU ARTHROSCOPE HRX KYPHON NEUCHATEL 0007082895

    Patients

    Seq Age Sex Outcome Treatment
    1