BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 2120817 · Received June 11, 2011

    Report

    Report Number
    1030489-2011-00731
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    August 4, 2010
    Report Date
    May 6, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MJO
    PMA / PMN Number
    P060023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: WEI, T ET AL. CLINICAL AND RADIOGRAPHIC RESULTS OF CERVICAL ARTIFICIAL DISC ARTHROPLASTY: OVER THREE YEARS FOLLOW-UP COHORT STUDY. CHINESE MEDICAL JOURNAL 2010;123(21):2969-2973. THE AVERAGE AGE OF THE PATIENTS WAS (B)(6) YEARS (RANGE FROM (B)(6) YEARS). THERE WERE 35 MEN AND 15 WOMEN. (B)(4).

    Description of Event or Problem · 1

    POSTOPERATIVE COMPLICATIONS WERE REPORTED IN A (B)(4) STUDY IN WHICH 50 PATIENTS UNDERWENT CERVICAL DISC ARTHROPLASTY FROM (B)(6) 2003 TO (B)(6) 2006. THE PATIENTS FAILED CONSERVATIVE THERAPY AFTER 3 MONTHS. THERE WERE 39 PATIENTS WHO RECEIVED 1-LEVEL DISC ARTHROPLASTY, AND 11 PATIENTS RECEIVED 2-LEVEL DISC ARTHROPLASTY. THERE WERE NO PERIOPERATIVE COMPLICATIONS. THE MEDIAN FOLLOW-UP WAS (B)(6) MONTHS (RANGE FROM 36.00-55.63 MONTHS). PROSTHESIS SUBSIDENCE OF MORE THAN 1 MM OCCURRED IN 2 PATIENTS AT 7- AND 12-MONTHS FOLLOW-UP. THE CAUSE WAS NOT IDENTIFIED, BUT THE PROSTHESES WAS NOTED TO HAVE REGAINED STABILIZATION AT LATER FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRYAN CERVICAL DISC SYSTEM MJO MEDTRONIC SOFAMOR DANEK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Disability