BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 3781440 · Received April 30, 2014

    Report

    Report Number
    1030489-2014-02356
    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

    (B)(4): NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER. (B)(4).

    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. OF THE 20 PATIENTS, THREE PATIENTS SHOWED MARKED DECREASES IN DISC MOTION AT THE SURGICAL LEVEL (RANGING FROM 67% TO 89% DECREASE) AND ONE PATIENT WITH ALMOST COMPLETE LOSS OF MOTION (99% DECREASE). ALTHOUGH ALL FOUR OF THESE PATIENTS SHOWED LOSS OF LORDOSIS AT THE SURGICAL LEVEL, ONLY ONE OF FOUR PATIENTS HAD POSTOPERATIVE KYPHOTIC FSU, WHICH WAS PRESENT PREOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260877 BRYAN CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other