BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 3764502 · Received April 22, 2014

    Report

    Report Number
    1030489-2014-02260
    Event Type
    Injury
    Date Received
    April 22, 2014
    Date of Event
    February 11, 2014
    Report Date
    April 2, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    P060023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE PUBLICATION THAT FROM (B)(6) 2005 TO (B)(6) 2007, 66 PATIENTS WITH (B)(4) CERVICAL TOTAL DISC REPLACEMENTS WERE PERFORMED. A STUDY WAS DONE TO ASSESS THE SAFETY AND EFFICACY OF THE DEVICE IN THE TREATMENT FOR CERVICAL DEGENERATIVE DISC DISEASE, AT 6-YEAR FOLLOW-UP. FIFTY-EIGHTY PATIENTS HAVE PERFORMED THEIR 6-YEAR FOLLOW-UP VISIT AND HAVE BEEN ANALYZED CLINICALLY AND RADIOLOGICALLY. SIXTY-FOUR TDR WERE PERFORMED IN THE 58 PATIENTS, 52 SUBJECTS RECEIVED SINGLE-LEVEL AND 6 UNDERWENT TWO-LEVEL DISC REPLACEMENTS. THE FOLLOWING DISCS WERE REPLACED: C3¿C4 (11 OR 17.0 %), C4¿C5 (20 OR 31.9 %), AND C5¿C6 (33 OR 51.1 %). OUT OF 58 PATIENTS, 10 SUBJECTS HAD RADIOGRAPHIC EVIDENCE OF HO, WITH 6 HAVING GRADE I, 2 HAVING GRADE II HO, 2 HAVING GRADE III HO. OVERALL, 12 OF THE 64 OPERATED SEGMENTS HAD RADIOGRAPHIC EVIDENCE OF HO, WHICH DOES NOT RESTRICT MOVEMENT OF THE PROSTHESIS. THERE WERE 2 CASES OF POSTERIOR MIGRATION OF THE PROSTHESIS, WHICH EVENTUALLY CONSOLIDATED. THE MIGRATION OF THE PROSTHESIS DID NOT CAUSE ANY CLINICAL SYMPTOMS, AND THE PATIENT DID NOT REQUIRE ANY FURTHER SURGERY. SIX OF 64 UPPER ADJACENT LEVELS SHOW A SLIGHT DEGRADATION (5 FROM GRADE 0 TO GRADE I, 5 FROM GRADE 0 TO GRADE II) AT 6-YEAR FOLLOW-UP, AND 4/64 LOWER ADJACENT LEVELS ADJACENT LEVELS SHOW A SLIGHT DEGRADATION (4 FROM GRADE 0 TO GRADE I, 2 FROM GRADE 0 TO GRADE II). DEGENERATIVE CHANGES DO NOT RESTRICT MOVEMENT OF THE PROSTHESIS. NO CASE SHOWED EVIDENCE OF SUBSIDENCE, WEAR OF THE IMPLANT. THERE WAS NO RADIOLOGICAL EVIDENCE OF RECURRENT SPONDYLOSIS AT THE OPERATED LEVEL OF ANY OF THE FUNCTIONAL PROSTHESES. NO SECONDARY CERVICAL SURGERY WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242381 BRYAN CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other