BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 4828818 · Received June 9, 2015

    Report

    Report Number
    1030489-2015-01156
    Event Type
    Malfunction
    Date Received
    June 9, 2015
    Report Date
    May 11, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: KAINING ZHANG, YINGCHUN SHEN, YANJUN REN, DEBO ZOU. "PREVENTION AND TREATMENT OF BONE CEMENT-RELATED COMPLICATIONS IN PATIENTS RECEIVING PERCUTANEOUS KYPHOPLASTY". THE MEAN AGE OF PATIENTS WAS 66.5 YEARS. THERE WERE 33 MALE PATIENTS AND 101 FEMALE PATIENTS. (B)(6). (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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT 134 CASES OF OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE PATIENTS TREATED WITH PERCUTANEOUS KYPHOPLASTY (PKP) BETWEEN AUGUST 2009 TO AUGUST 2013, WHICH INVOLVED 182 VERTEBRAL FRACTURES. OF THE 134 CASES, 33 WERE MALE AND 101 WERE FEMALE WITH AN AVERAGE AGE OF 66.5 YEARS OLD. HISTORY OF TRAUMA CAUSED BY HEAVY LIFTING OR LUMBAR SPRAIN WAS FOUND IN 81 PATIENTS. THERE WERE 112 CASES WITH SINGLE SEGMENT OF VERTEBRAL FRACTURE, 23 CASES WITH DOUBLE SEGMENTS OF VERTEBRAL FRACTURE AND 8 CASES WITH THREE SEGMENTS OF VERTEBRAL FRACTURE. FRACTURE INVOLVED SEGMENTS WERE AS FOLLOWS: T7, 3 CASES, T8, 5 CASES, T9, 10 CASES, T10, 15 CASES, T11, 39 CASES, T12, 42 CASES, L1, 36 CASES, L2, 19 CASES, L3, 9 CASES AND L4, 4 CASES. TO DIAGNOSE THE DISEASE AND TO UNDERSTAND THE POSTOPERATIVE CONDITION OF PATIENTS, A SERIES OF IMAGING EXAMINATIONS INCLUDING X RAY, CT AND MRI WERE PERFORMED BEFORE AND AFTER THE SURGERY. ALL PATIENTS WERE FOLLOWED UP FOR 11-33 MONTHS WITH AN AVERAGE OF 18 MONTHS. THREE SITES WERE LEAKAGE TO VERTEBRAL CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371707 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR