BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 6735199 · Received July 24, 2017

    Report

    Report Number
    1030489-2017-01815
    Event Type
    Malfunction
    Date Received
    July 24, 2017
    Report Date
    June 28, 2017
    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: "CURRENT SITUATION AND ISSUES OF BALLOON KYPHOPLASTY - REVIEW OF REPORTS IN THE PAST FIVE YEARS IN JAPAN." (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 THE LITERATURE THAT A META-ANALYSIS WAS PERFORMED OF VARIOUS LITERATURES AND CASES OVER A PERIOD OF FIVE YEARS IN (B)(6). THE TOTAL ADDRESSES WERE 48 IN JSSR AND 7 IN JOA, AND THE ORIGINAL PAPERS WERE 16 IN JSSR AND NONE IN JOA. THERE WERE 38 ORIGINAL PAPERS IN THE MEDICAL MAGAZINE. THE TOTAL CASES OF JSSR AND JOA PER YEAR HAD BEEN INCREASED SUCH AS 163 CASES IN 2012, 487 CASES IN 2013, 543 CASES IN 2014 AND 562 CASES IN 2015. THE NUMBER OF LITERATURES AND CASES IN THE MEDICAL MAGAZINE WAS 8 LITERATURES AND 130 CASES IN 2012, 9 LITERATURES AND 70 CASES IN 2013, 11 LITERATURES AND 397 CASES IN 2014, AND 10 LITERATURES AND 283 CASES IN 2015. POST-OPERATIVELY 1 PATIENT REPORTED CEMENT LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517500 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1