BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOURED CROSSBAR SMALL 3.5 ROD

    MDR report key: 3805003 · Received March 6, 2014

    Report

    Report Number
    2032593-2014-00012
    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
    PMA / PMN Number
    K080526
    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 ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE SECOND REPORT OF THREE REPORTS FROM THE SAME SURGERY ON THE SAME PT. (SEE MFG REPORT NUMBER 2032593-2014-00011). THIS REPORT CONCERNS THE CONTOURED CROSSBAR SMALL 3.5 ROD (PRODUCT ID 50-2011). IT WAS REPORTED THAT DURING A POSTERIOR CERVICAL FUSION SURGERY, 3 CROSSBARS BROKE DURING THE CASE. THE CUSTOMER SAID HE 'DID NOT KNOW IF IT HAD SOMETHING TO DO WITH THE TORQUE ON THE DRIVER'. 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 REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136266 CONTOURED CROSSBAR SMALL 3.5 ROD SIERRA KWP SEASPINE, INC. MW01753C/MW01951D

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR