BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 4028330 · Received August 21, 2014

    Report

    Report Number
    1030489-2014-03552
    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 : JUN OUCHIDA ET AL. "SPINAL ALIGNMENT IN ADJACENT VERTEBRAL FRACTURE AFTER BALLOON KYPHOPLASTY (BKP) AND PERCUTANEOUS VERTEBROPLASTY (PVP)". 1407-02; 2014/08/21. A2. 74±6 YEARS. A3. 8 MEN: 8 WOMEN. (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 THAT A STUDY COMPARING PERCUTANEOUS VERTEBROPLASTY AND BALLOON KYPHOPLASTY WAS CONDUCTED AND A TOTAL OF 16 PATIENTS UNDERWENT BALLOON KYPHOPLASTY PROCEDURES (BKP) OVER THE COURSE OF AN ELEVEN YEAR PERIOD AND WERE AVAILABLE FOR AT LEAST 3-MONTH FOLLOW-UP. THE STUDY PATIENTS WERE COMPOSED OF 15 MEN AND 31 WOMEN WITH THE MEAN AGE OF 75.0 YEARS (RANGE, 62 TO 86). BKP STUDY GROUP INCLUDED 16 PATIENTS TOTAL (8 MEN; 8 WOMEN / MEAN = 74 YEARS; RANGE = 68-80 YRS) UNDER GENERAL ANESTHESIA. THE AVERAGE FILL VOLUME WITH CEMENT WAS 5.3ML (RANGE 3.0ML-7.6ML). IT WAS REPORTED THAT 4 CASES OF "CEMENT LEAKAGE" WERE OBSERVED. THE TYPE OF CEMENT USED IN THIS STUDY WAS NOT SPECIFIED IN THE ABSTRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507361 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR BKP