BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUTTER

    MDR report key: 2880183 · Received December 19, 2012

    Report

    Report Number
    1030489-2012-02898
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    December 11, 2012
    Report Date
    January 8, 2013
    Manufacturer
    WARSAW ORTHOPEDICS, INC.
    Product Code
    MJO
    PMA / PMN Number
    P060023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 AND THE METAL DEBRIS UP TO THE LOCKING OF THE CUTTER MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCESS OF DRILLING HOLES FOR THE DISC IMPLANT, THE DRILL STOPPED/BROKE "WHEN SPACE WAS COMPRESSED". THE SURGEON HAD TO USE A NEW INSTRUMENT TO COMPLETE THE PROCEDURE. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUTTER PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS, INC. EM10G0551

    Patients

    Seq Age Sex Outcome Treatment
    1