BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 3781385 · Received April 30, 2014

    Report

    Report Number
    1030489-2014-02365
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    September 18, 2013
    Report Date
    April 14, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    P060023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: CAPPELLETTO ET AL. DISC PROSTHESIS REPLACEMENT AND INTERBODY FUSION IN THE TREATMENT OF DEGENERATIVE CERVICAL DISC DISEASE: COMPARATIVE ANALYSIS OF 176 CONSECUTIVE CASES. EUR SPINE J (2013) 22 (SUPPL 6):S894¿S899. (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE PUBLICATION THAT BETWEEN JANUARY, 2005 AND JUNE, 2011, 176 PATIENTS WITH CERVICO-BRACHIAL PAIN OR MYELOPATHY DUE TO CERVICAL HERNIATED DISC OR SPONDYLOSIS UNDERWENT MICRODISCETOMY BY THE ANTERIOR APPROACH. PATIENTS WERE DIVIDED INTO TWO GROUPS ON THE BASIS OF THE TYPE OF RECONSTRUCTION. GROUP A IS MADE UP OF 84 PATIENTS (42 FEMALES AND 42 MALES) IN WHOM THE PROSTHETIC DISC WAS IMPLANTED. IN 31 CASES, THE BRYAN PROSTHESIS (BRYAN MEDTRONIC SOFAMOR DANEK USA, INC.) WAS USED AND IN 53 CASES, A DISCOVER PROSTHESIS (DISCOVER DEPUY SPINE, INC.) WAS USED. IN 80 CASES, 1 DISC WAS SUBSTITUTED AND IN 4 CASES 2 DISCS WERE SUBSTITUTED, GIVING A TOTAL OF 88 DISC REPLACEMENTS. IN 91 % OF REPLACEMENTS THE OPERATION INVOLVED C6¿C7 (N = 42) OR C5¿C6 (N = 38). GROUP A IS COMPRISED OF PATIENTS WITH MEDIAN AGE OF 42 YEARS (RANGE 25¿60). GROUP B IS MADE UP OF 92 PATIENTS (41 FEMALES AND 51 MALES) IN WHOM DISC FUSION WAS PERFORMED. IN 64 CASES, A HETEROLOGOUS BONE GRAFT (UNILAB SURGIBONE UNILAB SURGIBONE, INC.) AND PLATE (ATLANTIS PLATE, MEDTRONIC SOFAMOR DANEK USA, INC.) WAS USED AND IN 28 CASES, INTERBODY FUSION CAGES IN PEEK PRE-FILLED WITH BONE SUBSTITUTE TRICALCIUM PHOSPHATE WAS USED. IN 71 CASES 1 DISC WAS SUBSTITUTED, IN 20 CASES 2 DISCS WERE SUBSTITUTED, AND IN 1 CASE 3 CONTIGUOUS DISCS WERE SUBSTITUTED, GIVING A TOTAL OF 114 DISCS TREATED. IN 75 % OF TREATED DISCS THE OPERATION INVOLVED C5¿C6 (N = 50) OR C6¿C7 (N = 35). GROUP B IS COMPRISED OF PATIENTS WITH MEDIAN AGE OF 51 YEARS (RANGE 26¿79). IN GROUP A, TWO PATIENTS (2.4 %) HADDYSPHAGIA; TWO PATIENTS (2.4 %) REQUIRED A SECOND OPERATION BECAUSE OF THE PULL-OUT OF THE PROSTHESIS. IN GROUP B, FOUR PATIENTS (4.3 %) HAD DYSPHAGIA; FIVE PATIENTS (5.4 %) REQUIRED A SECOND OPERATION BECAUSE OF THE PULL-OUT OF THE SCREWS OR NON-FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260822 BRYAN CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention