BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRYAN® CERVICAL DISC SYSTEM

    MDR report key: 3230142 · Received July 16, 2013

    Report

    Report Number
    1030489-2013-03049
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    August 23, 2012
    Report Date
    August 15, 2013
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    MJO
    PMA / PMN Number
    P060023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT FUNCTIONAL EVALUATION CONFIRMS PINION AND GEAR INTERFACE SLIPPAGE. 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)(6). (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE, DURING THE PROCEDURE, THE CUTTER WOULD NOT WORK CORRECTLY DURING THE MILLING PROCESS AND "WOULD NOT CUT THE APPROPRIATE DOME SHAPE FOR IMPLANTATION." NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329748 BRYAN® CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDIC, INC. EM12H029

    Patients

    Seq Age Sex Outcome Treatment
    1