BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 4965926 · Received August 4, 2015

    Report

    Report Number
    1030489-2015-01903
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Report Date
    July 6, 2015
    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

    (B)(6). 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. ALTHOUGH IT IS UNKNOWN IF ANY MEDTRONIC DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ABSTRACT THAT 255 UNDERWENT PERCUTANEOUS VERTEBROPLASTY (PVP) AND 122 PATIENTS UNDERWENT BALLOON KYPHOPLASTY ( BKP) TO TREAT SINGLE-LEVEL OSTEOPOROTIC VERTEBRAL FRACTURES (OVF) WITH INTERVERTEBRAL CLEFTS (IVC) BETWEEN 2003 AND 2012. IT WAS REPORTED THAT THE CEMENT LEAKAGE RATE WAS 24% IN BKP. THERE WAS NO NEUROLOGICAL SYMPTOM OR SYSTEMIC COMPLICATION DUE TO CEMENT LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509996 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1