BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 4578272 · Received March 6, 2015

    Report

    Report Number
    1030489-2015-00465
    Event Type
    Injury
    Date Received
    March 6, 2015
    Date of Event
    April 1, 2005
    Report Date
    February 19, 2015
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    P060023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: LAFUENTE ET AL. THE BRYAN CERVICAL DISC PROSTHESIS AS AN ALTERNATIVE TO ARTHRODESIS IN THE TREATMENT OF CERVICAL SPONDYLOSIS.THE JOURNAL OF BONE AND JOINT SURGERY. VOL. 87-B, NO. 4, APRIL 2005 F3: NATIONAL HOSPITAL FOR NEUROLOGY AND NEUROSURGERY, LONDON, GB. (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY LAFUENTE ET AL IN A LITERATURE PUBLICATION TITLED ¿THE BRYAN CERVICAL DISC PROSTHESIS AS AN ALTERNATIVE TO ARTHRODESIS IN THE TREATMENT OF CERVICAL SPONDYLOSIS¿ THAT: 46 PATIENTS UNDERWENT SURGERY FOR IMPLANT OF BRYAN ARTIFICIAL CERVICAL DISC. 28 PATIENTS WERE MALE AND 18 FEMALE. THE MEAN AGE WAS 47.6 YEARS. ONE PATIENT REQUIRED FURTHER SURGERY TO HAVE THE PROSTHESIS REMOVED FOLLOWING A FALL SEVEN MONTHS AFTER THE OPERATION. THE PATIENT COMPLAINED ONLY OF NECK PAIN AND SUFFERED NO NEUROLOGICAL DEFICIT BUT THE INFERIOR DISC PLATE WAS DISLODGED. THE PROSTHESIS WAS REMOVED AND REPLACED WITH AN INTERBODY CAGE, FOLLOWED BY A SMOOTH RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157428 BRYAN CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention