BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON EXPRESS INFLATABLE BONE TAMP

    MDR report key: 3971913 · Received July 31, 2014

    Report

    Report Number
    2953769-2014-00101
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    PMA / PMN Number
    K041454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL AND OPTICAL EXAMINATION OF THE IBT BALLOON IDENTIFIED A SMALL PINHOLE PUNCTURE NEAR THE DISTAL PEAK OF THE BALLOON. THE LOCATION, NATURE AND TIMING OF THE BALLOON PUNCTURE IS CONSISTENT WITH IN VIVO CONTACT WITH SHARP OBJECT, SUCH AS BONE SPLINTERS. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH IN VIVO CONTACT WITH SHARP OBJECT.

    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 BALLOON KYPHOPLASTY PROCEDURE (BKP) WAS PERFORMED AT L4 AND WHILE TRYING TO INFLATE ONE OF THE BALLOONS IN THE VERTEBRAL BODY, THE PHYSICIAN NOTICED THE THE PSI RATING WAS ZERO. THE BALLOON APPEARED PARTIALLY INFLATED ON FLUORO SO IT WAS DEFLATED AND REMOVED FROM THE PATIENT. OUTSIDE OF THE PATIENT, THE BALLOON WAS RE-INFLATED AND A SMALL LEAK WAS DETECTED. AN ADDITIONAL FRACTURE KIT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO KNOWN COMPLICATIONS REPORTED AND NO FRAGMENT OF THE DEVICE WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446426 KYPHON EXPRESS INFLATABLE BONE TAMP ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA 0007072035

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR BKP