BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE BUL LOR 9X9X27, 5 DG

    MDR report key: 3459704 · Received November 8, 2013

    Report

    Report Number
    1526439-2013-32910
    Event Type
    Malfunction
    Date Received
    November 8, 2013
    Date of Event
    October 17, 2013
    Report Date
    October 17, 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

    (B)(4). A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    CLARIFICATION FROM THE AFFILIATE REVEALED THAT THERE WAS NO BREAKAGE OF A HAMMER. THE CAGE BREAKAGE OCCURRED DURING INSERTION BY HAMMERING.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED CONCORDE BULLET CAGE NOTED THAT THE CAGE HAD BEEN FRACTURED. THE BROKE PIECE OF THE CAGE WAS REMOVED FROM THE PATIENT¿S BODY DURING SURGERY AND DISCARDED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS 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 LEOPARD CAGE BREAKAGE CANNOT POSITIVELY BE 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 ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE, AND THERE HAS BEEN NO SYSTEMATIC TREND. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS L4-L5/S1 INSTRUMENTATION WAS DONE WITH CONCORDE SYSTEM ON (B)(6) 2013. AFTER DECOMPRESSION, THE GRAFTED BONE WAS FILLED INTERVERTEBRALLY AND SPACE WAS MADE FOR CAGE INSERTION USING CONCORDE TRIALS. WHEN THE CONCORDE BULLET CAGE IN A HOLDER WAS IMPACTED, A HANDLE OF AN UNIDENTIFIED HAMMER WAS BROKEN. THE CAGE WAS HALF BROKEN WITH THE HALF INSERTED INTERVERTEBRALLY. THE CAGE WAS REPLACED WITH THE OTHER CAGE (9X9X23MM) AND FILLED WITH THE GRAFTED BONE TO COMPLETE THE CASE. THE SURGERY WAS DELAYED BY 15 MINUTES. NO ADVERSE CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS L4-L5/S1 INSTRUMENTATION WAS DONE WITH CONCORDE SYSTEM ON (B)(6) 2013. AFTER DECOMPRESSION, THE GRAFTED BONE WAS FILLED INTERVERTEBRALLY AND SPACE WAS MADE FOR CAGE INSERTION USING CONCORDE TRIALS. WHEN THE CONCORDE BULLET CAGE IN A HOLDER WAS IMPACTED, THE CAGE WAS HALF BROKEN WITH THE HALF INSERTED INTERVERTEBRALLY. THE CAGE WAS REPLACED WITH THE OTHER CAGE (9X9X23MM) AND FILLED WITH THE GRAFTED BONE TO COMPLETE THE CASE. THE SURGERY WAS DELAYED BY 15 MINUTES. NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577820 CONCORDE BUL LOR 9X9X27, 5 DG SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE APDB3M

    Patients

    Seq Age Sex Outcome Treatment
    1 UNIDENTIFIED HAMMER