BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 7345655 · Received March 16, 2018

    Report

    Report Number
    1030489-2018-00412
    Event Type
    Malfunction
    Date Received
    March 16, 2018
    Date of Event
    February 14, 2018
    Report Date
    May 25, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL AND MICROSCOPIC EXAMINATION OF THE -03 MILL GEAR AND -05 MILL PINION INTERFACING FEATURES IDENTIFIED SIGNIFICANT MATERIAL DEFORMATION. THE LOCATION AND NATURE OF THE WEAR IS CONSISTENT WITH INSTRUMENT USAGE. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH ANTICIPATED WEAR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 6474525, 510K# P060023 AND (B)(4) IS AVAILABLE FOR THE MARKET. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIANGOSED FOR DISC HERNIA. THE PATIENT UNDERWENT DYRAM DISC IMPLANTATION. INTRA-OP, AFTER THE CUTTER WAS UNPACKED AND CONNECTED BUT IT DID NOT ROTATE PROPERLY, SO HAD TO BE REPLACED. THE CUTTER CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLCATIONS WERE REPORTED ASA RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188418 BRYAN CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA EM15D029

    Patients

    Seq Age Sex Outcome Treatment
    1