BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIGE CERVICAL DISC SYSTEM

    MDR report key: 2873852 · Received December 14, 2012

    Report

    Report Number
    1030489-2012-02817
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    P060018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE REMAINS IMPLANTED. THE PRODUCT WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING IMPLANT OF AN ARTIFICIAL CERVICAL DISC THAT ONE OF THE LOCKING SCREWS WOULD NOT ENGAGE ONTO THE SUPERIOR PORTION OF THE IMPLANT. AFTER 20 MINUTES OF THE SURGEON ATTEMPTING TO ENGAGE THE SCREW, THE DOCTOR FINALLY USED A MALLET AND HIT THE SCREW INTO THE IMPLANT AND ENGAGED THE LOCKING SCREW INTO THE IMPLANT. THE SURGEON TURNED THE LOCKING SCREW A COUPLE OF TIMES BUT WASN'T COMPLETELY CONFIDENT IT WAS REALLY LOCKED. THE SCREW WAS LEFT IN PLACE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTIGE CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 ARTIFICIAL CERVICAL DISC