BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R? BONE CEMENT

    MDR report key: 4596619 · Received March 12, 2015

    Report

    Report Number
    1030489-2015-00540
    Event Type
    Malfunction
    Date Received
    March 12, 2015
    Date of Event
    February 13, 2015
    Report Date
    February 13, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    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, THE 510K # K041584 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 WAS REPORTED THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE (BKP) TO TREAT AN L2 OSTEOPOROTIC FRACTURE. IT WAS REPORTED THAT DURING CEMENT INJECTION, THE FLUOROSCOPIC IMAGE REVEALED CEMENT EXTRAVASATION INTO A LUMBAR VEIN. X-RAY AND CT WERE ALSO PERFORMED POST-OP AND CONFIRMED MILD EXTRAVASATION INTO THE VEIN. NO PATIENT SYMPTOMS WERE REPORTED IN ASSOCIATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170327 KYPHX® HV-R? BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA EL49514

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR BKP KIT