BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R? BONE CEMENT

    MDR report key: 3678985 · Received March 14, 2014

    Report

    Report Number
    1030489-2014-01835
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    February 13, 2014
    Report Date
    February 13, 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, THE CATALOG # C01A WITH 510K # K093828 OF A 'LIKE DEVICE' 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 A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE (BKP) AT L2 TO TREAT AN OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE. ACCORDING TO THE REPORT, INTRA-OP CEMENT EXTRAVASATION OCCURRED OUTSIDE THE VERTEBRAL BODY, POSSIBLY INTO THE SPINAL CANAL. THE PATIENT'S POSTERIOR WALL OF THE VERTEBRAL BODY WAS REPORTEDLY DAMAGED. CEMENT WAS REPORTEDLY INJECTED INTO BOTH CAVITIES AT THE SAME TIME AND THE INJECTION SPEED WAS REPORTEDLY "FAST." 2.5 CC OF CEMENT WAS INJECTED INTO THE RIGHT CAVITY AND 3.5 CC INTO THE LEFT. IT WAS REPORTED THAT CEMENT LEAKED LATERALLY OUTSIDE THE VERTEBRAL BODY AND VESSELS. NO HEALTH DAMAGE WAS REPORTED WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154710 KYPHX® HV-R? BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 IBT, INFLATION SYRINGE