BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 2122374 · Received June 13, 2011

    Report

    Report Number
    1030489-2011-00726
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    April 8, 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
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: KANG, KYUNG-CHUNG ET AL. THE FACTORS THAT INFLUENCE THE POSTOPERATIVE SEGMENTAL RANGE OF MOTION AFTER CERVICAL ARTIFICIAL DISC REPLACEMENT. THE SPINE JOURNAL 10 (2010) 689-696. THE MEAN AGE OF THE STUDY PATIENTS WAS (B)(6); THERE WERE 21 MALE PATIENTS AND 20 FEMALE PATIENTS. (B)(4). MULTIPLE PRODUCTS FROM MULTIPLE MANUFACTURERS WERE USED FOR THE STUDY. ALTHOUGH IT IS UNKNOWN IF OUR DEVICE CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    POSTOPERATIVE COMPLICATIONS WERE REPORTED FROM RETROSPECTIVE CLINICAL STUDY IN WHICH FORTY-ONE CONSECUTIVE CERVICAL ADR CASES WERE ANALYZED RETROSPECTIVELY. ALL CASES WERE TREATED BETWEEN (B)(6) 2004 AND (B)(6) 2007. TWO PATIENTS WERE TREATED AT C3-C4, 4 PATIENTS AT C4-C5, 26 PATIENTS AT C5-C6, AND 9 PATIENTS AT C6-C7. THE SURGICAL TECHNIQUES WERE SIMILAR TO THOSE FOR A ROUTINE ANTERIOR CERVICAL DECOMPRESSION AND FUSION. THREE TYPES OF ARTIFICIAL DISC DEVICES FROM THREE DIFFERENT MANUFACTURERS WERE USED. EVALUATIONS WERE PERFORMED PREOPERATIVELY AND AT 3, 6, AND 12 MONTHS AND AT LAST POST-OP FOLLOW-UP. FOLLOW UP AVERAGED 31 MONTHS (RANGE 24-54 MONTHS). FOR OPERATED SEGMENTS, GRADE 1 OSSIFICATIONS WERE PRESENT IN FOUR PATIENTS AND HETEROTOPIC OSSIFICATIONS OF GRADE 2 AND 3 WERE OBSERVED IN SIX AND FIVE PATIENTS RESPECTIVELY. AMONG THE 18 CASES OF HETEROTOPIC OSSIFICATIONS, 4, 3, AND 11 CASES WERE IDENTIFIED AT POSTOPERATIVE 6, 12, AND 24 MONTHS, RESPECTIVELY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR