BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUTTER

    MDR report key: 3111373 · Received May 14, 2013

    Report

    Report Number
    1030489-2013-01686
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    May 3, 2013
    Report Date
    June 10, 2013
    Manufacturer
    WARSAW ORTHOPEDICS, INC.
    Product Code
    MJO
    PMA / PMN Number
    P060023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT NO PRE-EXISTING DEFECT HAS BEEN IDENTIFIED ON THE RETURNED INSTRUMENTS WHICH COULD BE RESPONSIBLE OF THE EVENT. EXTRA LOAD APPLIED TO THE GEARS MECHANISM DURING THE CUT OF THE VERTEBRAL ENDPLATE MAY INDUCE AN IMPORTANT FRICTION WEAR RESPONSIBLE OF THE DAMAGE OF THE GEARS TEETH. DEVIATION OR NON-CONFORMANCE TO SPECIFICATIONS HAS BEEN RECORDED FOR THE LOT NUMBER EM10G0541. THIS NONCONFORMANCE WAS RELATED TO THE LASER MARK OF THE LOT NUMBER. THOSE DEVIATIONS DID NOT AFFECT THE MECHANICAL PROPERTIES OF THE INSTRUMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, "IT WAS REPORTED THAT THE CUTTER WAS USED IN CONJUNCTION WITH THE DISC TO PREPARE THE VERTEBRAL ENDPLATES. ON THE FIRST AFFECTED AREA, DISC SPACE PREPARATION AND DECOMPRESSION WERE DONE. WHEN THE SURGEON WENT TO MILL THE ENDPLATES, THE MILLING DEVICE DID NOT WORK AND THE GEARS WERE JAMMED. ANOTHER CUTTER WAS OPENED AND USED TO COMPLETE THE PROCEDURE." NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213258 CUTTER PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS, INC. EM10G0541

    Patients

    Seq Age Sex Outcome Treatment
    1