BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF-DRILLING VARIABLE BONE SCREW SINGLE LEAD 4.0 X 14MM

    MDR report key: 4660473 · Received October 30, 2014

    Report

    Report Number
    2032593-2014-00051
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 8, 2014
    Manufacturer
    SEASPINE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K032368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE THIRD REPORT OF THREE REPORTS CONCERNING THE SAME PT AND SAME SURGERY (SEE MFR REPORT NUMBER 2032593-2014-00049 AND 2032593-2014-00050). IT WAS REPORTED THE SURGEON PERFORMED AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) USING THE SONOMA PLATE SYSTEM. DURING THE PROCEDURE, HE INSERTED A 31MM 2 LEVEL PLATE AND THREE EACH OF THE 4.0 VARIABLE SCREWS. UPON TAKING AN X-RAY, HE DECIDED TO REMOVE THE PLATE AND SCREWS DUE TO AN X-RAY THAT WAS NOT ALLOWING THE PLATE TO SEAT PROPERLY. THE SURGEON ATTEMPTED TO REMOVE THE SCREWS FROM THE PLATE WITHOUT SUCCESS. THE PLATE WAS REMOVED WITH THE SCREWS STILL LOCKED INTO THE PLATE. ADDITIONAL INFO WAS REQUESTED AND RECEIVED ON (B)(6) 2014: THE SURGERY WAS DELAYED LESS THAN FIVE MINUTES. THERE WAS NO INJURY OR ADVERSE CONSEQUENCE TO THE FEMALE PT. SPARE DEVICES WERE AVAILABLE AND FUNCTIONED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697983 SELF-DRILLING VARIABLE BONE SCREW SINGLE LEAD 4.0 X 14MM SONOMA KWQ SEASPINE, INC. P162571D

    Patients

    Seq Age Sex Outcome Treatment
    1