BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 2119790 · Received June 10, 2011

    Report

    Report Number
    1030489-2011-00708
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    September 14, 2009
    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 ARTICLE: SEONG YI ET AL. DIFFERENCE IN OCCURRENCE OF HETEROTOPIC OSSIFICATION ACCORDING TO PROSTHESIS TYPE IN THE CERVICAL ARTIFICIAL DISC REPLACEMENT. SPINE VOLUME 35, NUMBER 16, PP 1556-1561. THE MEAN AGE OF THE STUDY PATIENTS WAS 43.4 YEARS; AGES RANGED FROM 26 TO 66. THERE WERE 48 MALE PATIENTS AND 56 FEMALE PATIENTS. (B)(4). 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 IN A RETROSPECTIVE STUDY OF 81 PATIENTS WHO UNDERWENT CERVICAL ARTHROPLASTY SINCE (B)(6) 2003 FOR CERVICAL ARTIFICIAL DISC REPLACEMENT (C4-C5 [N=12], C5-C6 [N=54] C6-C7 [N=15]). FIFTY-TWO PATIENTS UNDERWENT ARTIFICIAL DISC REPLACEMENT (ADR) ONLY; TWENTY-NINE PATIENTS UNDERWENT ADR WITH CONCURRENT CERVICAL FUSION SURGERY. DURING PERI-OPERATIVE PERIOD, MOST OF THE PATIENTS WERE TREATED WITH NONSTEROIDAL ANTI-INFLAMMATORY DRUGS FOR 2 TO 4 WEEKS ROUTINELY AFTER THE OPERATION. THE AVERAGE PERIOD OF FOLLOW UP WAS 24.3 MONTHS (12 TO 55 MONTHS). CERVICAL LATERAL RADIOGRAPHS AND COMPUTED TOMOGRAPHY WERE USED TO ASSESS PATIENT OUTCOME. IT WAS REPORTED THAT HETEROTOPIC OSSIFICATION (HO) WAS FOUND IN 17 PATIENTS (MCAFEE GRADE 1 HO = 4, GRADE 2 HO = 9, GRADE 3 HO = 2, GRADE 4 HO = 2). THE OSSIFICATION WAS FOUND MAINLY AT THE REGION ANTERIOR OR POSTERIOR TO THE OPERATED LEVEL.

    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