BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 2120821 · Received June 11, 2011

    Report

    Report Number
    1030489-2011-00732
    Event Type
    Injury
    Date Received
    June 11, 2011
    Date of Event
    August 2, 2010
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AVERAGE AGE OF THE PATIENTS WAS (B)(6). THERE WERE 11 MEN AND 11 WOMEN. (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; 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

    IT WAS REPORTED THAT TWENTY-TWO PATIENTS AT A SINGLE CENTER UNDERWENT DISCECTOMY AND IMPLANTATION OF ARTIFICIAL CERVICAL DISC. TWENTY PATIENTS UNDERWENT SINGLE-LEVEL ARTHROPLASTY AND TWO UNDERWENT ARTHROPLASTY AT TWO LEVELS. THE LEVELS OF SURGERY INCLUDED C3/4 (3 LEVELS), C4/5 (2 LEVELS), C5/6 (18 LEVELS) AND C6/7 (1 LEVEL). THE MEAN FOLLOW-UP PERIOD WAS 60 MONTHS (57-69 MONTHS). RADIOGRAPHIC EVALUATION INCLUDED DYNAMIC X-RAY EXAMINATION AND MAGNETIC RESONANCE IMAGING (MRI) AT BASELINE AND AT FINAL FOLLOW-UP. AT FIVE YEAR FOLLOW UP, EIGHT OUT OF 24 LEVELS HAD DEVELOPED HETEROTOPIC OSSIFICATION AND TWO HAD LOST MOTION (ROM). ACCORDING TO MCAFEE'S CLASSIFICATION, SIX LEVELS WERE CLASSIFIED AS GRADE III AND TWO AS GRADE IV. FOR THE SIX PATIENTS WITH GRADE III HETEROTROPIC OSSIFICATION, THE RANGE OF MOTION WAS 6.4° (4.0°-10.0°) AT BASELINE AND WAS PRESERVED AT 5.8° (2.0°-9.0°) AT FINAL FOLLOW-UP. THE RANGE OF MOTION OF TYPICAL CASE WITH GRADE III OSSIFICATION WAS PRESERVED AT 9.0 DEGREES.

    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 00043 YR