BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 3973662 · Received August 1, 2014

    Report

    Report Number
    1030489-2014-03384
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 4, 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: YURIE, HIROFUMI, ET AL. "CLINICAL OUTCOME OF BALLOON KYPHOPLASTY (BKP) IN OUR HOSPITAL". 1-B-G1-2; 1407-01. MEAN AGE = 81.1 YEARS (RANGE, 65 TO 99). 3 MEN, 8 WOMEN. (B)(6). (B)(4). NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. (B)(4). "CEMENT EXTRAVASATION". 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 MEDTRONIC DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STUDY GROUP OF 11 PATIENTS UNDERWENT SINGLE LEVEL BALLOON KYPHOPLASTY PROCEDURES (BKP) TO TREAT SPINAL COMPRESSION FRACTURES. THE AFFECTED LEVELS WERE T12 (N=4), L1 (N=1), L2 (N=4), AND L4 (N=1). THE MEAN OPERATIVE TIME WAS 24.8 MINUTES. CEMENT EXTRAVASATION INTO THE SPINAL CANAL WAS OBSERVED IN ONE CASE AND JUDGED TO BE A COMPLICATION. NO OTHER INFORMATION WAS PROVIDED IN THE ABSTRACT. THE TYPE OF CEMENT USED WAS NOT SPECIFIED IN THE ABSTRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449698 ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR BKP