BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 2120815 · Received June 11, 2011

    Report

    Report Number
    1030489-2011-00730
    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 50.9 YEARS (RANGE FROM 29.0 TO 73.0 YEARS). THERE WERE 35 MEN AND 15 WOMEN. (B)(4).

    Description of Event or Problem · 1

    POSTOPERATIVE COMPLICATIONS WERE REPORTED IN A PROSPECTIVE COHORT 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 41.85 MONTHS (RANGE FROM 36.00/55.63 MONTHS). ANTERIOR MIGRATION OF THE PROSTHESIS OF 2 MM WAS DETECTED IN ONE PATIENT AT THE 6-MONTH FOLLOW-UP. THIS WAS DUE TO A DEFICIENCY IN THE ENDPLATE MILLING PROCESS. THIS PATIENT HAS NO NEUROLOGICAL OR VASCULAR COMPLICATIONS, AND DOES NOT HAVE DYSPHAGIA NEITHER. THE PROSTHESIS WAS NOTED TO HAVE REGAINED STABILIZATION AT THE 18-MONTH FOLLOW-UP AND NO MORE EXTRUSION HAS BEEN NOTED AT THE MOST RECENT FOLLOW-UP OF 49 MONTHS.

    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