BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 4028077 · Received August 21, 2014

    Report

    Report Number
    1030489-2014-03551
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Report Date
    July 24, 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

    LITERATURE CITATION : KUNIO YOKOYAMA, M.D., MASAHIRO KAWANISHI, M.D., MAKOTO YAMADA, M.D. HIDEKAZU TANAKA, M.D., YUTAKA ITO, M.D., MASASHI HIRANO, M.D. "VERTEBRAL BODY HEIGHT RESTORATION AFTER BALLOON KYPHOPLASTY FOR ALGETIC SPINAL COMPRESSION FRACTURE". 1407-02; 2014/08/11. (B)(4): 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 IN AN ABSTRACT COMPARING VERTEBROPLASTY AND KYPHOPLASTY THAT 38 PATIENTS (41 VERTEBRAE) WERE TREATED WITH KYPHOPLASTY OVER A 15 MONTH PERIOD. IN THE STUDY, INDICATION FOR THE TWO SURGERIES WAS "OSTEOPOROTIC COMPRESSION FRACTURE RESISTANT TO CONSERVATIVE THERAPY FOR MORE THAN 2 WEEKS WITH DAILY LIFE-AFFECTING PAIN OF 5 OR MORE ON VISUAL ANALOGUE SCALE (VAS)". THE PATIENTS TREATED WITH KYPHOPLASTY UNDERWENT GENERAL ANESTHESIA FOR THE PROCEDURE WHICH INCLUDED INJECTION OF PMMA VIA BILATERAL TRANSPEDICULAR APPROACH AFTER INFLATION OF A BALLOON. IT WAS REPORTED THAT 5 VERTEBRA IN THE KYPHOPLASTY GROUP "WERE FOUND TO HAVE CEMENT LEAK OUT OF THE VERTEBRAL BODY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505720 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 BKP