BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R? BONE CEMENT

    MDR report key: 3886015 · Received June 20, 2014

    Report

    Report Number
    1030489-2014-02832
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # C01A WITH 510K # K093828 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.

    Description of Event or Problem · 1

    IT WS REPORTED THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE (BKP) AT L4. DURING CEMENT INJECTION, CEMENT EXTRAVASATION INTO THE ANTERIOR AND RIGHT LATERAL SIDES WAS OBSERVED. CEMENT INJECTION WAS IMMEDIATELY TERMINATED AND THE OPERATION WAS COMPLETED AFTER CEMENT WAS HARDENED. THE SURGICAL TIME WAS REPORTEDLY EXTENDED 16-30 MINUTES DUE TO THE INCIDENT. ACCORDING TO THE REPORT, THE CEMENT EXTRAVASATION "WOULD BE CAUTIOUSLY FOLLOWED UP FOR CT IMAGES SHOWED SOME CONCERNS BUT IT WAS CONFIRMED THAT THERE WAS NO CEMENT MIGRATION INTO HEART OR LUNGS". THE REPORT ALSO NOTED THAT "THE LATERALLY LEAKED CEMENT MAY HAVE LEAKED INTO A VESSEL". NO PATIENT SYMPTOMS WERE REPORTED AND NO INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363022 KYPHX® HV-R? BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR BKP