BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 2991012 · Received March 6, 2013

    Report

    Report Number
    1030489-2013-00673
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 8, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    P060023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: VISUAL AND OPTICAL EXAMINATION OF THE MILL GEAR AND MILL PINION INTERFACING FEATURES IDENTIFIED SIGNIFICANT MATERIAL PLASTIC DE FORMATION, CONSISTENT WITH OVERLOAD. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH OVERLOAD.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). LOCATION: HOSPITAL. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY FOR IMPLANT OF AN ARTIFICIAL CERVICAL DISC, THE CUTTING INSTRUMENT WOULD NOT SPIN TO CUT THE END PLATES. A SECOND CUTTER ALSO DID NOT WORK. A THIRD INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94935 BRYAN CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA EM10G048

    Patients

    Seq Age Sex Outcome Treatment
    1