BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSCOPE

    MDR report key: 3818770 · Received May 19, 2014

    Report

    Report Number
    1030489-2014-02558
    Event Type
    Injury
    Date Received
    May 19, 2014
    Report Date
    April 19, 2014
    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

    LITERATURE CITATION : D. TOGAWA, ET AL. "BALLOON KYPHOPLASTY ¿ NATIONAL SURVEY BY OSTEOPOROTIC VERTEBRAL COMPRESSION RESEARCH GROUP". 1404-02; 3-1-S3-3. (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. ALTHOUGH IT IS UNKNOWN IF ANY OF THE 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 A NATION-WIDE, MULTICENTER QUESTIONNAIRE FOR COMPLICATIONS OF BALLOON KYPHOPLASTY PROCEDURES (BKP) WAS CONDUCTED TO EXAMINE 2,743 CASES (OUT OF 164 INSTITUTIONS) WHICH RESPONDED TO THE QUESTIONNAIRE (RESPONSE RATE: 40%). THE EXAMINED CASES CONSISTED OF PATIENTS IN THEIR 50S (2%), 60S (11%), 70S (45%), 80S (38%), AND 90S (3%). THE TREATED LEVELS WERE T5-T7 (1%), T8-T10 (5.4%), T11-L2 (72.5%), AND L3-L5 (15.3%). THE TIMES FROM ONSET OF FRACTURE OR BACK PAIN TO TREATMENT WITH BKP WERE WITHIN 4 WEEKS (11%), 4-8 WEEKS (24%), 8-24 WEEKS (42%), AND 25 WEEKS OR LONGER (23%). IT WAS REPORTED THAT A POST-OP INFECTION OCCURRED IN 4 PATIENTS. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296955 ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention