BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 2474338 · Received March 1, 2012

    Report

    Report Number
    1030489-2012-00210
    Event Type
    Injury
    Date Received
    March 1, 2012
    Report Date
    February 2, 2012
    Product Code
    MJO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED DURING THE CLINICAL TRIAL PRIOR TO MARKET APPROVAL. PMA APPROVED DEVICE PRODUCT CODE IS MJO, PMA NUMBER P060023. (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ENROLLED IN THE CLINICAL STUDY UNDERWENT A PROCEDURE FOR ANTERIOR CERVICAL DISCECTOMY AND PLACEMENT OF ARTIFICIAL CERVICAL DISC AT C6-C7. APPROXIMATELY 82 MONTHS POST-OP, THE PATIENT HAD RIGHT SHOULDER PAIN AND INCREASED PAIN WITH SHOULDER MOTION. PATIENT TREATMENT INCLUDED MASSAGE THERAPY AND MEDICATIONS INCLUDED CELEXA AND IBUPROFEN. NO DIAGNOSTIC PROCEDURES WERE PERFORMED. THE ARTIFICIAL DISC REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRYAN CERVICAL DISC SYSTEM MJO 013-02115

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Other