BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE BULLET CAGE

    MDR report key: 4103127 · Received September 19, 2014

    Report

    Report Number
    1526439-2014-11912
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    June 16, 2014
    Report Date
    September 5, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MQP
    PMA / PMN Number
    PK052746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED CONCORDE CAGE (LOT NO: ARCB88) REVEALED THAT THE REVEALED THAT THE THREADS HAD BEEN COMPLETELY TORN/PEELED OFF ALONG THE FULL LENGTH OF THE INSERTION HOLE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THE LOT MET SPECIFICATIONS WHEN RELEASED TO STOCK. AS SUCH, PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A 12-MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE PRODUCT CODE FOUND NO EMERGING TRENDS. THE ROOT CAUSE OF THE 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 (CAPA) IS NECESSARY AT THIS TIME AS THERE HAVE BEEN NO ISSUES IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE CONCORDE CAGE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO SYSTEMIC TREND HAS BEEN OBSERVED FOR LOT CODE INVOLVED IN THIS COMPLAINT FILE. AS SUCH, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE HAD REPORTED THAT THE TWO CONCORDE BULLET CAGES WERE USED FOR THE LUMBAR CANAL STENOSIS CASE (L4-5). THE FIRST CAGE WAS INSERTED ON THE LEFT SIDE WITHOUT PROBLEM. DURING INSERTION OF THE SECOND CAGE ON THE RIGHT SIDE, IT WAS OBSERVED FROM THE LATERAL IMAGE THAT THE POSITION OF THE MARKERS ON THE LEFT CAGE CHANGED. THE SURGEON SUSPECTED THE INTERFERENCE AND REMOVED THE TWO CAGES. AFTER REMOVAL, THEY WERE FOUND TO BE DEFORMED. HE USED BACKUPS AND COMPLETED THE OPERATION. DUE TO THE INCIDENT, THE OPERATION WAS EXTENDED FOR TWENTY MINUTES WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. HOWEVER, RECEIPT OF THE TWO CONCORDE BULLET CAGES BY DEPUY SYNTHES SPINE ON (B)(4) 2014 AND EXAMINATION FOUND ONE CAGE WAS BROKEN AND THREADS ON THE INSERTION HOLE OF THE SECOND CAGE WERE TORN AND PEELED OFF ALONG THE LENGTH OF THE INSERTION HOLE. THE AFFILIATE CONFIRMED THAT THE DAMAGE HAD OCCURRED INTRA-OPERATIVELY. THE FOLLOWING MFG. MEDWATCH REPORTS ARE BEING FILED FOR THE TWO CONCORDE BULLET CAGES: 1526439-2014-11911; 1526439-2014-11912.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582028 CONCORDE BULLET CAGE SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE ARCB88

    Patients

    Seq Age Sex Outcome Treatment
    1