BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 2120639 · Received June 10, 2011

    Report

    Report Number
    1030489-2011-00718
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 22, 2010
    Report Date
    May 6, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MJO
    PMA / PMN Number
    P060023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: REN, XIANJUN ET AL. THE INTERMEDIATE CLINICAL OUTCOME AND ITS LIMITATIONS OF BRYAN CERVICAL ARTHROPLASTY FOR TREATMENT OF CERVICAL DISC HERNIATION. J SPINAL DISORD TECH. 2010. (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. ALTHOUGH IT IS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    POST OPERATIVE COMPLICATIONS WERE REPORTED FROM A PROSPECTIVE AND NONRANDOM STUDY THAT WAS CONDUCTED ON PATIENTS WITH CERVICAL HERNIATED DISCS. THE HERNIATED DISC WAS LOCATED AT C3-4 IN 2 CASES, AT C4-5 IN 8 CASES, AT C5-6 IN 24 CASES, AT C6-7 IN 5CASES, AT C4-5, 5-6 IN 2 CASES, AT C3,4, 5-6 IN 1 CASE, AND AT C 5-6, 6.7 IN 3 CASES. PATIENT SYMPTOMS INCLUDED HAND NUMBNESS, LIMB WEAKNESS, GAIT INSTABILITY, HYPERREFLEXIA, RADICULAR PAIN ON 1 ARM AND SENSORY DEFICIT CORRESPONDING TO SPECIFIC DERMATOMES AND WEAKNESS OF 1 UPPER SIDE EXTREMITY. THE PATIENTS HAD NOT RESPONDED TO CONSERVATIVE TREATMENT FOR AT LEAST 6 WEEKS. PATIENTS UNDERWENT STANDARD ANTERIOR CERVICAL FUSION WITH DISCECTOMY AND ARTIFICIAL DISC REPLACEMENT. A TOTAL OF 51 CERVICAL DISC PROSTHESIS WERE IMPLANTED; SINGLE LEVEL DISC WAS REPLACED IN 39 CASES AND 6 BILEVEL CASES. FOLLOW UP RANGED FROM 24 TO 70 MONTHS WITH AN AVERAGE OF 35 MONTHS. RADIOGRAPHS, INCLUDING MR, WERE TAKEN AT EACH FOLLOW UP VISIT. THERE WERE NO DEATHS, NO INFECTIONS AND NO INSTANCES OF IATROGENIC PROGRESSION IS ALL PATIENTS. ALL PATIENTS SHOWED IMPROVEMENT IN NEUROLOGICAL SYMPTOMS, WITH RADICULAR PAIN REFER TO ARM RELIEVED IN THE PATIENTS WITH RADICULOPATHY. STABILIZATION WAS ACHIEVED FOR ALL ARTIFICIAL DISCS AND MIGRATION OF ARTIFICIAL DISC GREATER THAN 2-MM WAS NOT OBSERVED. ONE PATIENT UNDERWENT DISCECTOMY AND DISC REPLACEMENT AT C5/C6. IMAGING FILMS SHOWED IMPLANTED DISC WAS IN GOOD POSITION 1 WEEK POST-OP. BONE RESORPTION GREATER THAN 2MM WAS SEEN AT THE ANTERIOR-INFERIOR EDGE OF THE UPPER VERTEBRAL BODY ON IMPLANTED LEVEL SIX MONTHS POST-OP AND SHOWED ALMOST THE SAME AT ONE YEAR FOLLOW UP. BONE RESORPTION WAS OBSERVED WITH NO FURTHER CHANGES OR DETERIORATION 3 YEARS POST-OP. THERE WAS NO DEVICE LOOSENING OR MIGRATION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRYAN CERVICAL DISC SYSTEM MJO MEDTRONIC SOFAMOR DANEK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR