BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 4260102 · Received November 18, 2014

    Report

    Report Number
    1030489-2014-04432
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Report Date
    October 20, 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: HIDETO SANO, MASAICHI HASEGAWA, MASAHITO TAKAHASHI, ATSUSHI HASEGAWA, SHOICHI ICHIMURA. "PREVENTIVE MEASURES FOR POSTOPERATIVE ADJACENT VERTEBRAL FRACTURE AT OUR MEDICAL INSTITUTION". (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 TOTAL 50 PATIENTS UNDERWENT BALLOON KYPHOPLASTY PROCEDURES (BKP), AND 43 OF THOSE PATIENTS WERE AVAILABLE FOR MORE THAN 3 MONTHS FOR FOLLOW-UP. PATIENTS WERE 16 MALES AND 27 FEMALES, AND THE AVERAGE AGE WAS 78.0 YEARS OLD. IT WAS REPORTED THAT "CEMENT MIGRATIONS" OCCURED IN SIX (6) PATIENTS. PREOPERATIVE CLEFT IN VERTEBRAL BODY AND INJURY IN SUPERIOR/INFERIOR ENDPLATES WERE OBSERVED TO ALL CASES OF THE CEMENT MIGRATION. THE TYPE OF CEMENT USED ON THESE PATIENTS WAS NOT SPECIFIED IN THE ABSTRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746633 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA` UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 BKP