BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 3130612 · Received May 24, 2013

    Report

    Report Number
    1030489-2013-01887
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    April 27, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NDN
    PMA / PMN Number
    K093828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: YUTAKA KOUNO, HOUGAKU GEN, YOSHIO SAKUMA, YASUYUKI KOJIKA, GO HAYASAKA, KEI MIYAGAWA. "RISK FACTORS OF ADJACENT VERTEBRAL FRACTURE AFTER BALLOON KYPHOPLASTY IN OSTEOPOROTIC VERTEBRAL FRACTURE". 3-5-F72-3. MEAN AGE: 78 YEARS. 8 MALES, 20 FEMALES. DATE(S) OF EVENTS ARE UNKNOWN. (B)(6). (B)(4). LOCATION : HOSPITAL. 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 OF 28 PATIENTS UNDERWENT BALLOON KYPHOPLASTY PROCEDURES (BKP) TO TREAT OSTEOPOROTIC VERTEBRAL FRACTURES WITH INTERVERTEBRAL CLEFTS. FRACTURES WERE OBSERVED AT LEVELS T11 (N=2), T12 (N=10), L1 (N=9), L2 (N=5), AND L3 (N=2). IT WAS REPORTED THAT 4 PATIENTS HAD "INTERVERTEBRAL DISK LEAKAGE OF BONE CEMENT". PMMA CEMENT WAS USED IN ALL PATIENTS UNDERGOING BKP. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232749 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR BKP