BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSBAR DRIVER

    MDR report key: 3805000 · Received March 6, 2014

    Report

    Report Number
    2032593-2014-00013
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 10, 2014
    Report Date
    February 10, 2014
    Manufacturer
    SEASPINE, INC.
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE THIRD REPORT OF THREE REPORTS FROM THE SAME SURGERY ON THE SAME PT. (SEE MFG REPORT NUMBER 2032593-2014-00011 AND MFG REPORT NUMBER 2032593-2014-00012). THIS REPORT CONCERNS THE CROSSBAR DRIVER (PRODUCT ID 95-0109). IT WAS REPORTED THAT DURING A POSTERIOR CERVICAL FUSION SURGERY, 3 CROSSBARS BROKE. THE CUSTOMER SAID HE 'DID NOT KNOW IF IT HAD SOMETHING TO DO WITH THE TORQUE ON THE DRIVER'. A SPARE CROSSBAR DEVICES WAS NOT AVAILABLE IN THE SET. SPARE CROSSBAR DEVICES WERE AVAILABLE, BUT THE SURGEON USED A CROSSLINK TO COMPLETE THE SURGERY. SURGERY TIME WAS INCREASED 15 MINUTES DUE TO THE REPORTED ISSUES. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT OR INJURY ALLEGED AS A RESULT OF THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136165 CROSSBAR DRIVER SIERRA KWP SEASPINE, INC. AL518912A-004

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR