BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 2137200 · Received June 22, 2011

    Report

    Report Number
    1030489-2011-00774
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    February 8, 2010
    Report Date
    May 6, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MJO
    PMA / PMN Number
    P060023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: QUAN, G ET A. EIGHT-YEAR CLINICAL AND RADIOLOGICAL FOLLOW-UP OF THE BRYAN CERVICAL DISC ARTHROPLASTY. SPINE 2011; 36 (8):PP 639-646. (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. RADIOGRAPHS PROVIDED IN THE LITERATURE ARTICLE SHOW C5/C6 CERVICAL ARTHROPLASTY, WHICH HAD MIGRATED POSTERIORLY BEFORE CONSOLIDATING. THE PROSTHESIS HAS RESTRICTED RANGE OF MOVEMENT BECAUSE OF GRADE 3 HETEROTOPIC OSSIFICATION.

    Description of Event or Problem · 1

    POSTOPERATIVE COMPLICATIONS WERE REPORTED IN PROSPECTIVE STUDY OF 21 PATIENTS WHO UNDERWENT A TOTAL OF 27 CERVICAL DISC ARTHROPLASTIES AFTER ANTERIOR CERVICAL DISCECTOMY USING AN ARTIFICIAL CERVICAL DISC FROM (B)(6) 2000 TO (B)(6) 2001. A SINGLE-LEVEL PROCEDURE WAS PERFORMED IN 15 PATIENTS AND A TWO-LEVEL PROCEDURE IN 6 PATIENTS. ALL SURGERIES WERE PERFORMED BY A SINGLE SURGEON USING IDENTICAL SURGICAL TECHNIQUES. ALL PATIENTS WERE REVIEWED ROUTINELY AT REGULAR INTERVALS POSTOPERATIVELY FOR 8 YEARS. NO PATIENT HAD PERSISTING RADICULOPATHY POSTOPERATIVELY OR ANY OTHER POSTOPERATIVE COMPLICATION REQUIRING PROLONGED HOSPITALIZATION OR REVISION SURGERY. THERE WAS ONE CASE OF POSTERIOR MIGRATION OF THE PROSTHESIS SOMETIME POST-OP, WHICH EVENTUALLY CONSOLIDATED. THE MIGRATION OF THE PROSTHESIS DID NOT CAUSE ANY CLINICAL SYMPTOMS AND THE PATIENT DID NOT REQUIRE ANY FURTHER SURGERY. THE PATIENT REMAINED COMPLETELY ASYMPTOMATIC.

    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 00037 YR