BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 3771458 · Received April 24, 2014

    Report

    Report Number
    1030489-2014-02301
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    May 17, 2013
    Report Date
    April 15, 2014
    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: ZHANG ET AL. CLINICAL AND RADIOGRAPHIC RESULTS OF BRYAN CERVICAL TOTAL DISC REPLACEMENT: 4-YEAR OUTCOMES IN A PROSPECTIVE STUDY. ARCH ORTHOP TRAUMA SURG (2013) 133:1061¿1066. (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE PUBLICATION THAT 20 PATIENTS UNDERWENT CERVICAL DISC REPLACEMENT WITH AN ARTIFICIAL CERVICAL DISC. THE 20 PATIENTS REPORTED ON IN THIS STUDY WERE RECRUITED DURING AN 18-MONTH PERIOD (JANUARY 2007 AND JULY 2008). THERE WERE 13 MALES AND 7 FEMALES WHO RANGED IN AGE FROM 36 TO 64 YEARS (MEAN 46.5 YEARS), AND THE DURATION OF SYMPTOMS RANGED FROM 8 TO 34 MONTHS (MEAN 18.6 MONTHS). 17 PATIENTS RECEIVED SINGLE-LEVEL AND THREE RECEIVED TWO-LEVEL DISC REPLACEMENT. THE FOLLOWING DISCS WERE REPLACED: C3¿C4 (4 OR 17.4 %), C4¿C5 (7 OR 30.4 %), C5¿C6 (12 OR 52.5 %). THE INCLUSION CRITERIA WERE SINGLE-LEVEL OR TWO-LEVEL DISC HERNIATION OR SPONDYLOSIS WITH RADICULOPATHY AND/OR MYELOPATHY WHICH HAD NOT RESPONDED TO CONSERVATIVE TREATMENT. THE MOST IMPORTANT EXCLUSION CRITERIA WERE PREVIOUS CERVICAL PROCEDURES, SIGNIFICANT CERVICAL ANATOMIC DEFORMITY, RADIOGRAPHIC SIGNS OF INSTABILITY, ACTIVE INFECTION AND IMPLANTATIONS BELOW C6 (FOR RADIOLOGICAL REASONS). FOLLOW-UP EVALUATION WAS PERFORMED AT 1, 6 MONTHS, AND 1, 2 AND 4 YEARS AFTER OPERATION. OF THE STUDIED PATIENTS, 4 OF THE 20 (20 %) HAD RADIOGRAPHIC EVIDENCE OF HO, WITH 2 OF THESE PATIENTS HAVING GRADE 1 AND 2 PATIENTS HAVING GRADE 2 HO. OVERALL, 6 OF THE 23 OPERATED SEGMENTS HAD RADIOGRAPHIC EVIDENCE OF HO, WHICH DOES NOT RESTRICT THE MOVEMENT OF THE PROSTHESIS. THERE WAS NO CASE OF ADJACENT-LEVEL DEGENERATION, AND NO PROSTHESIS SUBSIDENCE OR EXCURSION. THE MIDTERM OUTCOMES DEMONSTRATED THAT THE [ARTIFICIAL DISC] MAINTAINS FAVORABLE CLINICAL AND RADIOLOGICAL RESULTS, WITH PRESERVATION OF MOVEMENT AND SATISFACTORY CLINICAL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248551 BRYAN CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Other