BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER II INFLATABLE BONE TAMP

    MDR report key: 8782039 · Received July 11, 2019

    Report

    Report Number
    9612164-2019-02819
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    June 7, 2019
    Report Date
    May 22, 2020
    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

    PMA/510(K) #: 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. PRODUCT WAS NOT 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.

    Additional Manufacturer Narrative · 1

    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 UNDERWENT BALLOON KYPHOPLASTY DUE TO OSTEOPOROSIS. INTRA-OP, THE TIP OF THE BALLOON WAS DESTROYED. WHILE REMOVING THE BALLOON, THE BROKEN TIP OF THE BALLOON REMAINED IN PATIENT'S VERTEBRA. THE BROKEN FRAGMENT WAS EVENTUALLY EXPLANTED BY THE SURGEON BY ENLARGING THE WORKING CHANNEL. THE PROCEDURE WAS DELAYED BY 40 TO 45 MINUTES DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576258 KYPHON XPANDER II INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1