BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 2120809 · Received June 10, 2011

    Report

    Report Number
    1030489-2011-00729
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    March 29, 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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: LAZARO, B ET AL. EFFECT OF ARTHROPLASTY DESIGN ON CERVICAL SPINE KINEMATICS: ANALYSIS OF THE BRYAN DISC, PRODISC-C, AND SYNERGY DISC. NEUROSURG FOCUS 28 (6):E6, 2010. THE MEAN AGE OF THE PATIENTS WAS 43 YEARS; THE AGES RANGED FROM 32 TO 56. THERE WERE 12 MALES AND 8 FEMALES. (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    POST-OPERATIVE COMPLICATIONS WERE REPORTED IN RETROSPECTIVE ANALYSIS OF 18 PATIENTS THAT UNDERWENT SINGLE-LEVEL ARTHROPLASTY FOLLOWED BY CERVICAL TOTAL DISC REPLACEMENT (TDR). A STANDARD RIGHT-SIDED CERVICAL APPROACH FOR ANTERIOR CERVICAL DISCECTOMY (ACD) WAS PERFORMED IN ALL PATIENTS. LEVELS IMPLANTED INCLUDED 1 AT C3/C4, 1 AT C4/C5, 9 AT C5/C6 AND 9 AT C6/C6. THERE WAS IMMEDIATE RELIEF OF RADICULOPATHY AND/OR MYELOPATHY IN ALL CASES, WITH NO OPERATIVE OR DEVICE-RELATED COMPLICATIONS. NO DELAYED COMPLICATIONS WERE OBSERVED. DYNAMIC RADIOGRAPHS OF THE CERVICAL SPINE WERE ANALYZED USING QUANTITATIVE MOTION ANALYSIS SOFTWARE TO ANALYZE THE KINEMATICS AT THE INDEX LEVEL BOTH PREOPERATIVELY AND POSTOPERATIVELY. SIGNIFICANT SHELL ANGLE (SA) KYPHOSIS WAS FOUND AT LATE FOLLOW-UP (3.4 ± 4.7°); PREOPERATIVE LORDOSIS WAS 3.0 ± 3.1°. AN INCREASE IN KYPHOSIS (> 4°) AT THE INDEX LEVEL IN THE NEUTRAL POSITION WAS FOUND IN 60% OF THE PATIENTS. LATERAL RADIOGRAPHS DEMONSTRATED SA KYPHOSIS IN THE NEUTRAL POSTURE FOLLOWING INSERTION OF ARTIFICIAL DISC. THE AUTHORS ALSO REPORTED THE ANTERIOR DISC HEIGHT DECREASED BY 32% AND THE POSTERIOR DISC HEIGHT (PDH) DECREASED BY 14%. THE AUTHORS DID NOT SPECIFY THE NUMBER OF PATIENTS IN WHICH THE DISC HEIGHT DECREASED.

    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 00043 YR