BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER II INFLATABLE BONE TAMP

    MDR report key: 8649198 · Received May 29, 2019

    Report

    Report Number
    9612164-2019-02063
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Date of Event
    April 29, 2019
    Report Date
    July 28, 2019
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    HRX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL AND OPTICAL INSPECTION CONFIRMED THE IBT HAS BEEN USED. OPTICAL AND FUNCTIONAL INSPECTION CONFIRMED THAT THE IBT HAS BEEN RUPTURED. THIS TYPE OF DAMAGE/RUPTURE IS CONSISTENT WITH THE BALLOON COMING IN CONTACT WITH BONE SPLINTERS WHILE IN THE VERTEBRAL BODY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # KX203, 510K # K101864 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PREOPERATIVELY DIAGNOSED WITH VERTEBRAL BODY FRACTURE; AND UNDERWENT KYPHOPLASTY. INTRA-OP, THE BALLOON BURST WHEN THE VOLUME OF THE BALLOON WAS ABOUT 5 ML AND AT 329 PSI PRESSURE. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. THE SURGEON THEN DECIDED TO COMPLETE SURGERY WITH CEMENT INSERTION. THERE WAS DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444251 KYPHON XPANDER II INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC MEXICO NA 0009322121

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR