BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON® EXPRESS¿ II INFLATABLE BONE TAMP

    MDR report key: 8109559 · Received November 28, 2018

    Report

    Report Number
    1030489-2018-01568
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    November 5, 2018
    Report Date
    November 28, 2018
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L DE C.V.
    Product Code
    HRX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG #KE102, 510K #K123771 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 PRE-OPERATIVELY DIAGNOSED WITH VERTEBRAL COMPRESSION FRACTURE (VCF) AND UNDERWENT BALLOON KYPHOPLASTY (BKP) PROCEDURE AT T9 LEVEL. DURING SURGERY, THE IBT BURST. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THE PRESSURE AND VOLUME PRIOR TO RUPTURE WERE RECORDED AS BEING 245 PSI AND 2.5CC RESPECTIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951768 KYPHON® EXPRESS¿ II INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC MEXICO S. DE R.L DE C.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1