BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 4203806 · Received October 27, 2014

    Report

    Report Number
    1030489-2014-04139
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Report Date
    September 29, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT A RETROSPECTIVE REVIEW OF ALL KYPHOPLASTY PROCEDURES PERFORMED FOR SOLID TUMORS AT A SINGLE SPECIALIZED CANCER CENTER BETWEEN THE MONTHS OF (B)(6) OF 2011 WAS EVALUATED TO DETERMINE THE INCIDENCE OF POST-KYPHOPLASTY VERTEBRAL RE-FRACTURES AND THE EFFECT ON PATIENTS. ACCORDING TO THE ARTICLE, 92 PATIENTS UNDERWENT KYPHOPLASTY OVER THE 9 MONTH PERIOD. TEN PATIENTS WERE EXCLUDED FROM THE STUDY FOR LACK OF TWO-MONTH FOLLOW-UP OR FOR SUFFERING FROM MYELOMA. NINETY-SEVEN VERTEBRAE WERE TREATED WITH KYPHOPLASTY, 61 IN MALE PATIENTS, AND 36 IN FEMALES. AVERAGE AGE WAS 66. AVERAGE FOLLOW-UP WAS 3.5 MONTHS. IT WAS REPORTED THAT FIFTEEN REFRACTURES OCCURRED, CAUSING A DECREASE OF 4.4 MM OF VERTEBRA HEIGHT. NO PATIENT COMPLICATIONS WERE REPORTED IN THE ARTICLE FOR THESE PATIENTS AND NO PRODUCT MALFUNCTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684778 ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR BKP, CEMENT, BALLOONS