BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 7326326 · Received March 9, 2018

    Report

    Report Number
    1030489-2018-00354
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    February 27, 2018
    Report Date
    June 7, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 UPN (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 UNDERWENT CERVICAL DISC ARTHROPLASTY AT C4 - C6 DUE TO DEGENERATED CERVICAL DISC-SPACE. DURING THE SURGERY, THE CUTTER WAS NOT TURNING INSIDE THE VERTEBRA. THE SURGEON TRIED THE CUTTER BEFORE HE PUT IT INTO THE CERVICAL SPINE BETWEEN THE VERTEBRA AND IT WAS RUNNING FREE. WHEN IT WAS BETWEEN THE VERTEBRA, IT GAVE A LOUD "CRACK" AND THERE WERE SOME METAL PIECES LAYING ON THE DURA (ABOUT 6-8). IT SEEMED LIKE THE TRANSITION BROKE WHEN THERE WAS SOME FORCE APPLIED TO IT. THE SURGEON RINSED THE SITUS SEVERAL TIMES TO REMOVE THE FRAGMENTS OF THE BROKEN CUTTER. OUTSIDE THE PATIENT, THE CUTTER WAS RUNNING PROPERLY, INSIDE WITH SOME FORCE ON IT, IT WAS NOT TURNING. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171637 BRYAN CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA EM15A009

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR