BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSCOPE

    MDR report key: 3814207 · Received May 15, 2014

    Report

    Report Number
    1030489-2014-02538
    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. MORISUE, ET AL. "CLINICAL RESULTS OF REVISION SURGERY FOR PATIENTS WHO HAVE UNDERGONE BALLOON KYPHOPLASTY". 1404-02; 2-P50-2. (B)(4): 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.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ABSTRACT THAT A TOTAL OF 73 PATIENTS WITH VERTEBRAL COMPRESSION FRACTURES UNDERWENT BALLOON KYPHOPLASTY PROCEDURES (BKP) OVER A 42 MONTH PERIOD. THE PRIMARY DISEASES INCLUDED PRIMARY OSTEOPOROSIS IN 8 CASES, PARKINSON¿S DISEASE IN 1, AND RHEUMATOID ARTHRITIS IN 2. THE TREATED LEVELS RANGED FROM TH6 TO L5; IN 8 (10 VERTEBRAE) OUT OF THE 11 CASES, A REGION EQUIVALENT OR INFERIOR TO THE THORACOLUMBAR SPINE WAS TREATED. ALL CASES WITH AN ADVERSE EVENT REQUIRING REOPERATION WERE ALLOCATED TO EITHER GROUP 1, 2, OR 3 BY CAUSE OF REOPERATION. IT WAS REPORTED THAT THERE WERE SEVEN CASES OF "EARLY POSTOPERATIVE REFRACTURE" (GROUP 1) THAT REQUIRED REOPERATION. EACH PATIENT REPORTEDLY RECEIVED BKP AND SIMULTANEOUS SPINAL FUSION VIA ANTERIOR POSTERIOR APPROACHES, RESPECTIVELY. NO OTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291536 ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention