BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSCOPE

    MDR report key: 3973954 · Received August 1, 2014

    Report

    Report Number
    1030489-2014-03385
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 4, 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

    (B)(4). LOCATION : UNKNOWN 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 THAT IN AN ABSTRACT THAT TOTAL OF 8 PATIENTS UNDERWENT BALLOON KYPHOPLASTY PROCEDURES (BKP) WITH POSTERIOR FIXATION TO TREAT COMPRESSION FRACTURES. OF THE 8 PATIENTS, 7 WERE TREATED WITH A 2-LEVEL FUSION, AND ONE WITH A 4-LEVEL FUSION. THE MEAN FOLLOW-UP PERIOD WAS 7 MONTHS. IT WAS REPORTED THAT TWO CASES OF RE-FRACTURE OF THE TREATED LEVELS WAS FOUND IN 2 CASES, COLLAPSE OF THE BKP-TREATED VERTEBRAL BODY, IN 2. NO INCIDENT FRACTURE WAS OBSERVED AT ANY SITES OTHER THAN THE FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450804 ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Other