BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER II INFLATABLE BONE TAMP

    MDR report key: 9283556 · Received November 6, 2019

    Report

    Report Number
    9612164-2019-04647
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Date of Event
    October 9, 2019
    Report Date
    November 6, 2019
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    HRX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH VERTEBRAL BODY FRACTURE AND UNDERWENT BALLOON KYPHOPLASTY (BKP) PROCEDURE. DURING SURGERY, THE BALLOON HAD BURST IN THE VERTEBRAL BODY AT THE PRESSURE OF 150PSI. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW PRODUCT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080688 KYPHON XPANDER II INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1