BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 1770356 · Received July 21, 2010

    Report

    Report Number
    1030489-2010-00939
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    January 18, 2008
    Report Date
    June 21, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MJO
    PMA / PMN Number
    P060023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LITERATURE CITATION: V, HEIDECK, ET AL. INTERVERTEBRAL DISC REPLACEMENT FOR CERVICAL DEGENERATIVE DISEASE - CLINICAL RESULTS AND FUNCTIONAL OUTCOME AT TWO YEARS IN PATIENTS IMPLANTED WITH THE BRYAN CERVICAL DISK PROSTHESIS. ACTA NEUROCHIRUGICA (2008)150:453-459. A REVIEW OF THE DEVICE RECORDS IS NOT POSSIBLE WITHOUT ADD'L DEVICE INFO. NEITHER THE DEVICE NOR (TEST RESULTS OR IMAGING FILMS) WERE RETURNED TO THE MANUFACTURER FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENTS UNDERWENT A STANDARD ANTERIOR CERVICAL DISCECTOMY AND A CERVICAL DISC PROSTHESIS WAS IMPLANTED IN THE AFFECTED LEVEL(S). FIVE PATIENTS HAD LOSS OF FUNCTION (RANGE OF MOTION LESS THAN 3 DEGREES) WITH ADVANCED HETEROTOPIC OSSIFICATION. THERE WERE NO IMPLANT DISLOCATIONS OR MIGRATIONS. A GOOD OR EXCELLENT NEUROLOGICAL OUTCOME WAS NOTED IN ALL PATIENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability