BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE CEMENT

    MDR report key: 4100012 · Received September 18, 2014

    Report

    Report Number
    1030489-2014-03714
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Report Date
    August 21, 2014
    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 : AKIHISA YAMASHITA, KENZO SHIRASAWA, TETSUYA WATANABE. "RELATION TO THE SPINAL SAGITTAL PLANE BALANCE AND SURGICAL RESULTS OF BALLOON KYPHOPLASTY FOR THORACOLUMBAR OSTEOPOROTIC VERTEBRAL FRACTURE". 2-P49-2. A2. MEAN AGE = 76.5 YEARS. A3. 5 MALE; 12 FEMALE PATIENTS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ABSTRACT THAT OVER A 17 MONTH PERIOD A TOTAL OF 17 PATIENTS (MALE: 5 PATIENTS, FEMALE 12 PATIENTS) UNDERWENT BKP TO TREAT OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES. MEAN AGE AT THE SURGERY WAS 76.5 YEARS. MEAN FOLLOW-UP PERIOD WAS 13.3 MONTHS. MEAN SURGICAL TIME WAS 38 MINUTES, AND MEAN FLUOROSCOPY TIME WAS 6.5 MINUTES. IT WAS REPORTED THAT 3 CASES OF CEMENT EXTRAVASATION WERE OBSERVED. NO PATIENT SYMPTOMS WERE REPORTED. THE TYPE OF CEMENT USED WAS NOT SPECIFIED IN THE ABSTRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578291 BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR BKP