BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 3768577 · Received April 23, 2014

    Report

    Report Number
    1030489-2014-02291
    Event Type
    Injury
    Date Received
    April 23, 2014
    Date of Event
    December 1, 2012
    Report Date
    April 3, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    P060023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: KHONG ET AL. CERVICAL DISC ARTHROPLASTY FOR THE TREATMENT OF SPONDYLOTIC MYELOPATHY AND RADICULOPATHY. JOURNAL OF CLINICAL NEUROSCIENCE. ISSUE 20 (2013) 1411¿1416. DEVICES USED IN THE STUDY INCLUDED MEDTRONIC SOFAMOR DANEK BRYAN DISC, MEDTRONIC SOFAMOR DANEK PRESTIGE DISC, AND CERVITECH PCM ARTIFICIAL DISC. (B)(4). NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE PUBLICATION THAT BETWEEN (B)(6) 2003 AND (B)(6) 2008, A SINGLE SURGEON PERFORMED CDA ON A TOTAL OF 55 PATIENTS. THE PATIENTS HAD CERVICAL RADICULOPATHY, CERVICAL MYELOPATHY, OR BOTH, CAUSED BY DEGENERATIVE DISC DISEASE THAT HAD NOT RESPONDED TO NON-OPERATIVE MANAGEMENT. FOR THE PURPOSES OF REPORTING, THE THREE PATIENTS WHO HAD RADICULOPATHY AS WELL AS MYELOPATHY WERE GROUPED WITH THOSE WHO HAD MYELOPATHY, ON THE GROUNDS THAT MYELOPATHY WAS THE MORE SERIOUS CONDITION. THE RADICULOPATHY GROUP CONSISTED OF 23 MALES AND 14 FEMALES WITH AN AVERAGE AGE OF 48, THE MYELOPATHY GROUP 12 MALES AND 6 FEMALES WITH AN AVERAGE AGE OF 42. SEVERAL CDA DEVICES WERE USED AT THE DISCRETION OF THE SURGEON OUTCOME DATA WERE NOT AVAILABLE FOR FOUR OF THE 55 PATIENTS, WHO WERE LOST TO FOLLOW-UP. OF THE REMAINING 51 PATIENTS, FIVE SUFFERED TECHNICAL OR PATHOLOGIC FAILURES AFTER INITIAL TREATMENT, AND HAD TO UNDERGO RESCUE TREATMENT. THEIR EVENTUAL TREATMENT INVOLVED MORE THAN CDA. THEREFORE, BECAUSE THEIR CLINICAL OUTCOMES COULD NOT BE ATTRIBUTED SOLELY TO USING CDA, THESE PATIENTS WERE NOT INCLUDED IN THE GROUP OUTCOME DATA. HOWEVER, THEY WERE INCLUDED IN THE ESTIMATIONS OF SUCCESS RATES FOR CDA, IN WHICH REGARD THEY WERE CLASSIFIED AS HAVING NOT HAD A SUCCESSFUL OUTCOME. THE REMAINING 46 PATIENTS PROVIDED OUTCOME DATA REFLECTIVE OF THE USE OF CDA ALONE. THREE OF THE FIVE FAILURES HAD SIGNIFICANT ADJACENT SEGMENT DISEASE AT THE TIME OF THE CDA, WHICH SUBSEQUENTLY BECAME SYMPTOMATIC. TWO DEVELOPED SYMPTOMS AT THE INDEX LEVEL ¿ INADEQUATE DECOMPRESSION MAY HAVE PLAYED A ROLE. THERE WERE NO DEVICE FAILURES. PATIENT 3 UNDERWENT AN INITIAL PROCEDURE FOR IMPLANT OF ARTIFICIAL CERVICAL DISC AT C6-C7. PATIENT HAD RECURRENCE OF NECK/LEFT ARM PAIN, AND ONGOING C5-C6, C6-C7 FORAMINAL STENOSIS. PATIENT UNDERWENT A SECONDARY OPERATION FOR ACDF AT C5-C6 AND C6-C7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247709 BRYAN CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1