BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE BUL LOR 9X9X27, 5 DG

    MDR report key: 3425183 · Received October 23, 2013

    Report

    Report Number
    1526439-2013-31295
    Event Type
    Malfunction
    Date Received
    October 23, 2013
    Date of Event
    September 4, 2013
    Report Date
    September 4, 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

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED CONCORDE BULLET CAGE NOTED THAT THE CAGE THREADS HAD BEEN SHEARED OFF APPROXIMATELY HALFWAY ALONG THE FULL LENGTH OF THE HOLE. THE CAGE WAS ADDITIONALLY CRACKED FROM THE THREAD TO THE TOOTH ON THE SURFACE OF THE IMPLANT. A REVIEW OF THE DHR FOR THE CONCORDE BULLET CAGE WAS CONDUCTED IDENTIFYING A LOT RELEASED ON OCTOBER 26TH, 2012. NO DISCREPANCIES WERE OBSERVED DURING THE MANUFACTURING PROCESS. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THE PRODUCT THAT COULD HAVE BEEN CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPANYING ALL QUALITY REQUIREMENTS. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO OBSERVED TRENDS FOR ISSUES OF THIS NATURE. THE ROOT CAUSE OF THE SHEARED THREADS ON THE CONCORDE BULLET CAGE CANNOT POSITIVELY BE DETERMINED. HOWEVER, AS NOTED IN THE ACCOMPANYING INSTRUCTIONS FOR USE (IFU-0902-90-077 REVISION D), 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. IT SHOULD ALSO BE NOTED THAT AFTER FURTHER DISC CLEARING AND ENDPLATE PREPARATION, A CAGE WAS SUCCESSFULLY IMPLANTED INDICATING THAT THE CAGE SIZE SELECTION MAY HAVE ALSO PLAYED A ROLE IN THE FRACTURED IMPLANT. AS THERE HAS BEEN NO ISSUES IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE AND THERE HAS BEEN NO OBSERVED COMPLAINT TREND THIS FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Additional Manufacturer Narrative · 1

    TO THE BEST OF THE AFFILIATE SALES REPRESENTATIVE'S KNOWLEDGE, THE CAGE WAS DEFORMED AND WAS NOT BROKEN. HOWEVER, RECEIPT OF THE CAGE BY DEPUY SYNTHES SPINE ON OCTOBER 22, 2013 FOUND THE CAGE TO BE CRACKED NEAR THE INSERTION HOLE. AS SUCH, THE DATE WHEN DEPUY SYNTHES SPINE BECAME AWARE THAT THE CAGE WAS CRACKED AND WAS A REPORTABLE MALFUNCTION WAS OCTOBER 22, 2013.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE HAD REPORTED THAT THE CONCORDE INSERTER INSTRUMENT CAUSED DAMAGE TO THE THREADS OF THE INSERTION HOLES IN THREE CONCORDE BULLET CAGES. WHEN THE SURGEON TRIED TO CHANGE THE POSITION OF FIRST CAGE FROM SUPERIOR TO INFERIOR IN THE DISC SPACE, THE CAGE CAME OFF OF THE INSERTER AND THE THREADS OF THE CAGE¿S INSERTION HOLE WERE DEFORMED, PREVENTING THE DEVICE FROM REATTACHING TO THE INSERTER. THE SAME CONDITION OCCURRED WITH A SECOND CAGE. A THIRD CAGE COULD NOT BE SET FIRMLY ONTO THE INSERTER AND THE THREADS OF THAT CAGE¿S INSERTION HOLE WERE DEFORMED AS WELL. THE SURGEON SCRAPED THE BONE AND DISC SPACE, A FOURTH CAGE WAS INSERTED INTO THE DISC SPACE, AND THE PROCEDURE WAS COMPLETED. AS A RESULT OF THE DIFFICULTIES, SURGERY WAS EXTENDED BY THIRTY MINUTES. THE AFFILIATE REPORTS THAT NO ADVERSE CONSEQUENCES WERE REPORTED. MFG MEDWATCH REPORT NO. 1526439-2013-28740 WAS FILED FOR THE CONCORDE INSERTER. HOWEVER, RECEIPT OF THE DEVICES INVOLVED IN THIS EVENT FOUND ONE CAGE, CATALOG# 187827409, LOT ANLDLC, WAS CRACKED NEAR THE INSERTION HOLE. THIS MFG MEDWATCH REPORT 1526439-2013-31295 IS BEING FILED FOR THIS CRACKED CAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544112 CONCORDE BUL LOR 9X9X27, 5 DG SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE ANLDLC

    Patients

    Seq Age Sex Outcome Treatment
    1