BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 5760746 · Received June 30, 2016

    Report

    Report Number
    1030489-2016-01918
    Event Type
    Malfunction
    Date Received
    June 30, 2016
    Date of Event
    January 23, 2016
    Report Date
    June 2, 2016
    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: XIAO CHEN, CHUNYANG MENG, WEIHONG ZHANG, XIANGQING KONG, FENG GAO "EFFICACIES OF PERCUTANEOUS VERTEBRAL ANGIOPLASTY, PERCUTANEOUS KYPHOPLASTY AND CONVENTIONAL OPEN OPERATION IN THE TREATMENT OF SPINAL TUMOR". 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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, FORTY-SEVEN PATIENTS WHO WERE ADMITTED TO THE HOSPITAL WERE DIVIDED INTO THREE GROUPS: PVP GROUP (TREATED WITH PVP) ,PERCUTANEOUS KYPHOPLASTY(PKP) GROUP (TREATED WITH PKP) AND CONTROL GROUP (TREATED WITH CONVENTIONAL OPEN OPERATION). THREE MONTHS AFTER OPERATION, THE TOTAL EFFECTIVE RATE OF PVP, PKP AND CONTROL GROUP WAS 86.7%, 94.4%, 57.1. ALL PATIENTS HAD SIGNIFICANTLY LOWER VAS SCORE, LOWER NRS SCORE AND HIGHER KPS SCORE AFTER THE TREATMENT COMPARED WITH THOSE BEFORE THE TREATMENT (ALL P <(><<)> 0.01). PATIENTS UNDERWENT PVP AND PKP SHOWED THAT THE HEIGHT OF THE VERTEBRAL BODY WAS NOT COLLAPSED BY X-RAY EXAMINATION. THE PKP GROUP HAD THE FOLLOWING COMPLICATIONS: ONE BONE CEMENT LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417243 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1