BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE BUL LOR 9X11X27, 5 DG

    MDR report key: 3379703 · Received October 1, 2013

    Report

    Report Number
    1526439-2013-29027
    Event Type
    Malfunction
    Date Received
    October 1, 2013
    Date of Event
    September 11, 2013
    Report Date
    September 12, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MQP
    PMA / PMN Number
    PK052746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED CONCORDE BULLET CAGE FOUND THE DEVICE TO HAVE CRACKED IN HALF THROUGH THE THREADED PORTION OF THE CAGE. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PRODUCTION LOT FOUND NO DISCREPANCIES RELATED TO THE REPORTED EVENT. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE PRODUCT CODE FOUND NO OBSERVED TRENDS FOR ISSUES OF THIS NATURE. THE ROOT CAUSE THE CAGE BREAKAGE CANNOT BE POSITIVELY DETERMINED. HOWEVER, AS NOTED IN THE ACCOMPANYING INSTRUCTIONS FOR USE, EXCESSIVE TORQUE, WHEN APPLIED TO LONG-HANDLE INSERTION TOOLS, CAN CAUSE SPLITTING OR FRACTURE OF THE POLYMER/CARBON-FIBER IMPLANTS. WHEN A POLYMER/CARBON-FIBER IMPLANT IS IMPACTED OR HAMMERED INTO PLACE, THE BROAD SURFACE OF THE INSERTION TOOL SHOULD BE CAREFULLY SEATED FULLY AGAINST THE IMPLANT. IMPACTION FORCES APPLIED DIRECTLY TO A SMALL SURFACE OF THE IMPLANT COULD CAUSE FRACTURE OF THE IMPLANT. NO CORRECTIVE ACTION/PREVENTIVE ACTION IS REQUIRED AS THERE HAS BEEN NO ISSUES IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THESE DEVICES, AND THERE HAVE BEEN NO SYSTEMATIC TRENDS. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Additional Manufacturer Narrative · 1

    DEPUY SYNTHES DOES NOT USE THERAPY DATES AS REQUIRED. AS A RESULT, TODAY'S DATE HAS BEEN ENTERED INTO THE REQUIRED FIELD. A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT THE THREADS OF THE SET SCREW BECAME TORN WHEN THE DEVICE WAS LOOSENED FROM A PREVIOUSLY IMPLANTED PEDICLE SCREW. BOTH SCREWS WERE REMOVED AND REPLACED INTRA-OPERATIVELY. ALSO, A CONCORDE BULLET CAGE WAS CRACKED DURING ADVANCEMENT INTO THE DISC SPACE USING A BAYONET INSERTER. THE CAGE WAS REMOVED WITHOUT ISSUE. THE AFFILIATE REPORTS THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO SIGNIFICANT DELAY. SEE MFG MEDWATCH REPORT NO. 1526439-2013-29025 FOR THE MIS SINGLE INNER SET SCREW THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495101 CONCORDE BUL LOR 9X11X27, 5 DG SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE ANNCFB

    Patients

    Seq Age Sex Outcome Treatment
    1 INSERTER, CATALOG# UNKNOWN