BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSCOPE

    MDR report key: 3814068 · Received May 15, 2014

    Report

    Report Number
    1030489-2014-02529
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 18, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION : H. YASUOKA, ET AL. "EFFECT OF TERIPARATIDE WITH BKP (BALLOON KYPHOPLASTY) METHOD ¿DOES TERIPARATIDE PREVENT NEW VERTEBRAL FRACTURES AFTER BKP ¿ STUDY OF 20 CASES WITH 22 VERTEBRA". 1404-02; 2-P50-1. (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ABSTRACT THAT A TOTAL OF 20 PATIENTS (22 VERTEBRAE) UNDERWENT BALLOON KYPHOPLASTY PROCEDURES (BKP) AFTER BEING DIAGNOSED WITH DELAYED-UNION OF THORACOLUMBAR COMPRESSION FRACTURE AND WERE FOLLOWED UP FOR MORE THAN THREE MONTHS. THE MEAN AGE WAS 80.3 YEARS. THE FRACTURE LEVELS WERE TH12 (N=7), L1 (N=9), L2 (N=3), L3 (N=2), AND L4 (N=1). THE MEAN FOLLOW-UP PERIOD WAS 8.3 MONTHS. ALL PATIENTS WERE GIVEN TERIPARATIDE DAILY EITHER PREOPERATIVELY (8 VERTEBRAE) OR POSTOPERATIVELY (14 VERTEBRAE). IN ONE CASE, PARALYSIS OCCURRED PERIOPERATIVELY AND WAS FOUND TO HAVE BEEN CAUSED BY COLLAPSE OF THE TREATED . THE PATIENT WAS TREATED WITH DECOMPRESSION AND FUSION VIA POSTERIOR APPROACH. NO FURTHER INFORMATION WAS REPORTED IN THE ABSTRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291509 ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention