BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 2120620 · Received June 10, 2011

    Report

    Report Number
    1030489-2011-00725
    Event Type
    Injury
    Date Received
    June 10, 2011
    Report Date
    May 6, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MJO
    PMA / PMN Number
    P060023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: ZHOU, LJ ET AL. CLINICAL OBSERVATION OF MID-STAGE COMPLICATIONS AFTER CERVICAL DISC REPLACEMENT. ZHONGGUO GU SHANG. 2010 JUL;23(7):514-517 A2: THE MEAN AGE OF THE STUDY PATIENTS WAS (B)(6) YEARS; AGES RANGED FROM 39 TO 69 YEARS A3: STUDY CONSISTED OF 34 MEN AND 20 WOMEN. (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS 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 THE DEVICE CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    POST OPERATIVE COMPLICATIONS WERE REPORTED IN LITERATURE SUMMARIZATION OF BRYAN CERVICAL DISC REPLACEMENTS. FROM (B)(6) 2005 TO (B)(6) 2008, 54 PATIENTS WITH CERVICAL SYNDROME WERE TREATED WITH SINGLE LEVEL PROSTHETIC CERVICAL DISC REPLACEMENT. THE PATIENTS WERE FOLLOWED FOR 24-36 MONTHS WITH AN AVERAGE OF 30 MONTHS. IT WAS REPORTED THE INCIDENCE RATE OF HETEROTOPIC OSSIFICATION AND PROSTHETIC FUSION WENT UP YEAR BY YEAR. TWO PATIENTS THE FIRST YEAR, NINE PATIENTS FOR THE SECOND YEAR AND TWELVE FOR THE NEARLY THIRD YEAR.

    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