BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 3781531 · Received April 30, 2014

    Report

    Report Number
    1030489-2014-02352
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    April 8, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    P060023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE FOR ONE LEVEL CERVICAL ARTHROPLASTY WITH IMPLANT OF ARTIFICIAL DISC. APPROXIMATELY 2 MONTHS POST-OP THE PATIENT SUFFERED A FALL ON ICED. X-RAY REVEALED THE DEVICE HAD MIGRATED ANTERIORLY ABOUT 5MM. PATIENT HAD SYMPTOMS OF NECK PAIN AND ARM WEAKNESS. AT 3 MONTHS POST-OP THE PATIENT UNDERWENT A REVISION PROCEDURE FOR DEVICE REMOVAL AND 1 LEVEL ACDF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260002 BRYAN CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA 0280357W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention