BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 3021661 · Received March 26, 2013

    Report

    Report Number
    1030489-2013-00862
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    P060023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: VISUAL AND OPTICAL EXAMINATION OF THE -03 MILL GEAR AND -05 MILL PINION INTERFACING FEATURES IDENTIFIED SIGNIFICANT MATERIAL PLASTIC DEFORMATION. THE LOCATION AND NATURE OF THE WEAR IS CONSISTENT WITH INSTRUMENT USAGE; THIS INSTRUMENT IS A SINGLE-USE INSTRUMENT. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH ANTICIPATED WEAR.

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO IMPLANT THE ARTIFICIAL DISC AT C5-C6, THE CUTTER STOPPED WORKING WHILE THE SURGEON WAS PREPARING THE DISC SPACE. A NEW ONE WAS OPENED AND USED WITH NO FURTHER ISSUES. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124410 BRYAN CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA EM11C010

    Patients

    Seq Age Sex Outcome Treatment
    1