BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSCOPE

    MDR report key: 5238408 · Received November 20, 2015

    Report

    Report Number
    1030489-2015-03097
    Event Type
    Injury
    Date Received
    November 20, 2015
    Report Date
    October 21, 2015
    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: TOSHIAKI KOTANI, TSUTOMU AKAXAWA, TSUYOSHI SAKUMA, TETSUHARU NEMOTO, YASUSHI IIJIMA, YOHEI SHIMADA, SHOHEI MINA MI."IMPLEMENTATION OF A CLINICAL PATHWAY AMONG HOSPITAL AND GENERAL PRACTITIONERS FOR OSTEOPOROTIC VERTEBRAL FRACTURES: COMBINATION OF BALLOON KYPHOPLASTY AND WEEKLY TERIPARATIDE INJECTIONS". MEAN AGE WAS 76.7±6.3 (66-91) YEARS. 3 MEN AND 31 WOMEN. (B)(6). (B)(4). ALTHOUGH IT IS UNKNOWN IF ANY MEDTRONIC DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ABSTRACT THAT TOTAL 50 PATIENTS WHO WERE NOT IMPROVED IN PAIN SUFFICIENTLY WITH CONSERVATIVE TREATMENT UNDERWENT BALLOON KYPHOPLASTY (BKP) BETWEEN THE PERIOD OF NOV 2012 - OCT 2013. 34 OUT OF 50 PATIENTS WERE OBSERVED FOR 6 MONTHS WITH ONCE-A-WEEK. IT WAS REPORTED THAT REFRACTURE OCCURRED IN 5 PATIENTS (14.7%) AND 4 OF THEM UNDERWENT BKP AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768692 ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention BKP