BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSCOPE

    MDR report key: 3806233 · Received May 12, 2014

    Report

    Report Number
    1030489-2014-02498
    Event Type
    Injury
    Date Received
    May 12, 2014
    Report Date
    April 17, 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 : M. AOKI, ET AL. "CLINICAL RESULTS OF BALLOON KYPHOPLASTY FOR OSTEOPOROTIC VERTEBRAL FRACTURES ¿ POSTOPERATIVE CORRECTION LOSS OF WEDGE RATIO". 1404-02: 1-4-F3-6. A2. MEAN AGE WAS 78.2 YEARS (RANGE: 61 TO 91). A3. 14 MEN, 40 WOMEN. (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 A STUDY ABSTRACT THAT TOTAL OF 54 PATIENTS (14 MALE AND 40 FEMALE; 57 VERTEBRAE) UNDERWENT BALLOON KYPHOPLASTY PROCEDURES (BKP) OVER A 28 MONTH PERIOD. MEAN AGE WAS 78.2 YEARS (RANGE: 61 TO 91), MEAN FOLLOW-UP PERIOD WAS 6.1 MONTHS, AND OPERATIVE TIME WAS 31.3 MINUTES. IT WAS REPORTED THAT "COLLAPSE OF THE BKP-TREATED VERTEBRAL BODY, WHICH WAS THOUGHT TO HAVE CAUSED THE LOSS OF CORRECTION, WAS OBSERVED IN 44 PATIENTS (77.2%) ". NO FURTHER INFORMATION WAS REPORTED IN THE ABSTRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284657 ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Other