BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 2970319 · Received February 20, 2013

    Report

    Report Number
    1030489-2013-00567
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    August 1, 2012
    Report Date
    January 28, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    P060023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: SUN ET AL. COMPARISON OF ADJACENT SEGMENT DEGENERATION FIVE YEARS AFTER SINGLE LEVEL CERVICAL FUSION AND CERVICAL ARTHROPLASTY: A RETROSPECTIVE CONTROLLED STUDY, CHINESE MEDICAL JOURNAL 2012;125(22):3939-3941. PT AGE: RANGE 20 TO 53 YRS. PT SEX: 14 MEN, 12 WOMEN. (B)(6). (B)(4). NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    TWENTY-SIX PATIENTS WHO UNDERWENT SINGLE LEVEL ARTHROPLASTY WERE FOLLOWED UP FOR FIVE YEARS. FOLLOW-UP PERIODS RANGED FROM 57 TO 74 MONTHS. MOST PATIENTS HAD C5/6 IMPLANTS. A CONTROL GROUP OF TWENTY-FOUR PATIENTS WHO UNDERWENT SINGLE LEVEL ACDF WERE FOLLOWED UP FOR 5 YEARS. IN THE ARTHROPLASTY GROUP, NINE (17.6%) SEGMENTS DEVELOPED ADJACENT SEGMENT DEGENERATION, WHICH WAS SIGNIFICANTLY LOWER THAN THAT (60.4%) IN THE ANTERIOR CERVICAL DECOMPRESSION AND FUSION GROUP. ELEVEN SEGMENTS IN THE ARTHROPLASTY GROUP DEVELOPED HETEROTOPIC OSSIFICATION ACCORDING TO MCAFEE'S CLASSIFICATION AND TWO SEGMENTS HAD RANGE OF MOTION LESS THAN 2 DEGREES. IN THE HETEROTOPIC OSSIFICATION GROUP, FOUR (19.5%) SEGMENTS DEVELOPED ADJACENT SEGMENT DEGENERATION, SIMILAR TO THE NUMBER IN THE NON-HETEROTOPIC OSSIFICATION GROUP (16.7%). ADJACENT SEGMENT DEGENERATION RATE WAS 50% IN GRADE IV GROUP BUT 11.8% IN GRADE II TO III. IN CONCLUSION, ARTHROPLASTY AVOIDED ACCELERATED ASD BY MOTION PRESERVATION. HO DEVELOPMENT AFTER ARTHROPLASTY MAY INFLUENCE THE ASD. HOWEVER, A LARGER SAMPLE AND LONGER FOLLOW-UP ARE NEEDED TO EVALUATE THE EFFECTS OF HO AFTER ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73986 BRYAN CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other