BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON EXPRESS II INFLATABLE BONE TAMP

    MDR report key: 8784200 · Received July 12, 2019

    Report

    Report Number
    9612164-2019-02832
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 12, 2019
    Report Date
    July 12, 2019
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    HXG
    UDI-DI
    00763000025656
    PMA / PMN Number
    K123771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 UNDERWENT BALLOON KYPHOPLASTY AT T11 AND T12 DUE TO MELENOMA WITH DIFFUSE BONE TUMORS THROUGHOUT SPINE. INTRA-OP, THE BALLOON RUPTURED INSIDE PATIENT'S VERTEBRA. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. THE PROCEDURE WAS COMPLETED WITH A NEW PRODUCT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME; AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577255 KYPHON EXPRESS II INFLATABLE BONE TAMP TAMP HXG MEDTRONIC MEXICO NA UNK 00763000025656

    Patients

    Seq Age Sex Outcome Treatment
    1