BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 3781435 · Received April 30, 2014

    Report

    Report Number
    1030489-2014-02357
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    February 18, 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
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: RYU ET AL. LONG-TERM KINEMATIC ANALYSIS OF CERVICAL SPINE AFTER SINGLE-LEVEL IMPLANTATION OF BRYAN CERVICAL DISC PROSTHESIS. THE SPINE JOURNAL 13 (2013) 628¿634. (B)(4): NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE PUBLICATION THAT 20 PATIENTS (13 MALES, 7 FEMALES) UNDERWENT SINGLE-LEVEL CERVICAL ARTHROPLASTY, INCLUDING 1 PATIENT AT C3¿C4, 1 PATIENT AT C4¿C5, 10 PATIENTS AT C5¿C6, AND 8 PATIENTS AT C6¿C7 LEVELS. THERE WAS IMMEDIATE RELIEF OF RADICULOPATHY AND/OR MYELOPATHY IN ALL CASES; 18 OF 20 PATIENTS DEMONSTRATED FSU ANGLE CHANGE THAT WAS EITHER A DECREASE IN LORDOSIS, LORDOSIS TO KYPHOSIS, OR AN INCREASE IN KYPHOSIS FROM PREOPERATIVE VALUES. TEN OF 20 PATIENTS HAD LORDOTIC FSU AT PREOPERATIVE IMAGING, AND 3 OF THESE 10 PATIENTS SHOWED CHANGES TOWARD KYPHOSIS AT FOLLOW-UP. THE REMAINING 10 PATIENTS HAD PREOPERATIVE STRAIGHTENING OF FOCAL KYPHOSIS OF THE SPINE. PATIENTS WITH A STRAIGHT SPINE DEMONSTRATED KYPHOSIS AFTER SURGERY AT THE INDEX LEVEL. ARTHROPLASTY INCREASED THE KYPHOSIS AT THE INDEX LEVEL IN PATIENTS WITH PREOPERATIVE KYPHOSIS. IN THE SUBSEQUENT FOLLOW-UP, THE FSU ANGLE REMAINED STABLE UP TO 5 YEARS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260156 BRYAN CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other