BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 3490057 · Received November 26, 2013

    Report

    Report Number
    1030489-2013-04820
    Event Type
    Malfunction
    Date Received
    November 26, 2013
    Report Date
    October 31, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 A STUDY ARTICLE THAT 20 OSTEOPOROTIC VERTEBRAL FRACTURE (OVF) CASES WERE TREATED WITH BALLOON KYPHOPLASTY (BKP) AND FOLLOWED A MINIMUM OF SIX MONTHS. THE OVF WITH INJURED POSTERIOR WALL WAS FIRST TREATED BY CORRECTING THE VERTEBRA AND THE INVAGINATED BONE SEGMENT WITH A BODY CAST. NEXT, 4-WEEK BED REST WAS ORDERED FOR ALL PATIENTS IN THE STUDY. UPON SYSTEMATIC CHECK-UP, BKP WAS PERFORMED. POSTOPERATIVELY, HARD CORSET WAS USED UNTIL INJURED POSTERIOR WALL UNION WAS ACHIEVED. IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED IN ONE CASE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616381 ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1