BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4206780 · Received October 22, 2014

    Report

    Report Number
    2032593-2014-00050
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 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 EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE SECOND REPORT OF THREE REPORTS CONCERNING THE SAME PT AND SAME SURGERY. (SEE MFG REPORT NUMBER 2032593-2014-00049). 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 A 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 10/14/2014: THE SURGERY WAS DELAYED LESS THAN 5 MINUTES. THERE WAS NO INJURY OR ADVERSE CONSEQUENCES TO THE FEMALE PT. SPARE DEVICES WERE AVAILABLE, AND FUNCTIONED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674219 SELF-DRILLING VARIABLE BONE SCREW SINGLE LEAD 4.0 X 14MM SONOMA KWQ SEASPINE, INC. P153801D

    Patients

    Seq Age Sex Outcome Treatment
    1