BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 8559805 · Received April 29, 2019

    Report

    Report Number
    1030489-2019-00484
    Event Type
    Malfunction
    Date Received
    April 29, 2019
    Date of Event
    April 6, 2019
    Report Date
    April 29, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: TAKAHASHI S, ET AL. DEVELOPMENT OF A SCORING SYSTEM FOR PREDICTING ADJACENT VERTEBRAL FRACTURE AFTER BALLOON KYPHOPLASTY. THE SPINE JOURNAL 000 (2019) 1-8. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE LITERATURE TITLED ¿DEVELOPMENT OF A SCORING SYSTEM FOR PREDICTING ADJACENT VERTEBRAL FRACTURE AFTER BALLOON KYPHOPLASTY¿ THAT 116 PATIENTS WERE INCLUDED IN THE ANALYSIS. THE PURPOSE OF THE STUDY WAS TO ESTABLISH A SCORING SYSTEM FOR PREDICTING ADJACENT VERTEBRAL FRACTURE (AVF) OCCURRENCE AFTER BALLOON KYPHOPLASTY FOR OSTEOPOROTIC VERTEBRAL FRACTURES (OVFS). 109 PATIENTS WITH ALL THE REQUIRED DATA AT THE TIME OF ENROLMENT AND THE 6-MONTH FOLLOW-UP WERE INCLUDED IN THE STUDY. BALLOON KYPHOPLASTY WAS PERFORMED. POST-OP, CEMENT LEAKAGE WAS OBSERVED IN 12 (17%) PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352946 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1