BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTHESIS, INTERVERTEBRAL DISC

    MDR report key: 4152880 · Received October 8, 2014

    Report

    Report Number
    1030489-2014-03934
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 2, 2014
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    MJO
    PMA / PMN Number
    P060023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL SURGERY. DURING THE PROCEDURE, THE CUTTER DID NOT TURN IN SITU. A NEW I NSTRUMENT HAD TO BE USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630948 PROSTHESIS, INTERVERTEBRAL DISC PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDIC, INC. EM11C029

    Patients

    Seq Age Sex Outcome Treatment
    1