BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE BUL LOR 9X8X27, 5 DG

    MDR report key: 3596386 · Received January 29, 2014

    Report

    Report Number
    1526439-2014-11141
    Event Type
    Malfunction
    Date Received
    January 29, 2014
    Date of Event
    January 6, 2014
    Report Date
    January 6, 2014
    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 SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION NOTED THAT A PORTION OF THE INSERTER SIDE OF THE CAGE HAD BEEN FRACTURED. ADDITIONALLY, THE THREADS ON THE INSERTER SIDE OF THE CAGE HAD BECOME COMPLETELY SHEARED OFF. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE CONCORDE BULLET LORDOTIC 9X8X27, 5 DEGREE FOUND NO DISCREPANCIES DURING THE MANUFACTURING OF THE PRODUCT. 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 12-MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE CONCORDE BULLET LORDOTIC 9X8X27, 5 DEGREE WAS CONDUCTED ON THE SPECIFIC PRODUCT CODE FROM THIS COMPLAINT AS THE HEIGHT OF THE IMPLANT AFFECTS THE STRESS PROFILE ON INSERTION AND THEREFORE THIS HEIGHT IS NOT INDICATIVE OF THE FAMILY OR VICE VERSA. IT WAS NOTED THAT THERE WERE NO RELATED COMPLAINTS FOR ISSUES OF THIS NATURE. REVIEW OF COMPLAINTS FOUND NO SIGNIFICANT TRENDS. THE ROOT CAUSE OF THE CONCORDE BULLET LORDOTIC 9X8X27, 5 DEGREE 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 (CAPA) IS NECESSARY AT THIS TIME AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THIS DEVICE, NOR THERE HAS BEEN ANY SYSTEMATIC TREND. THEREFORE, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CAGE WITH INSERTER WAS BEING PLACED DURING A PROCEDURE AND AS THE HAMMER WAS BEING USED ON THE INSERTER, THE INSERTER SIDE OF THE CAGE BROKE AND THE SCREW HOLDING THE INSERTER STRIPPED. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE WITH A 15 MINUTES DELAY TO SURGICAL TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64054 CONCORDE BUL LOR 9X8X27, 5 DG SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE K052746

    Patients

    Seq Age Sex Outcome Treatment
    1