BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE BUL LOR 9X9X27, 5 DG

    MDR report key: 6453074 · Received April 3, 2017

    Report

    Report Number
    1526439-2017-10223
    Event Type
    Malfunction
    Date Received
    April 3, 2017
    Date of Event
    March 6, 2017
    Report Date
    March 6, 2017
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MAX
    PMA / PMN Number
    K151773
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE INCORRECT IN MW-426952. DATE RECEIVED BY MANUFACTURER= APRIL 10TH 2017. DISCOVERED (B)(6) 2017. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE (1) CONCORDE BULLET 9X9X27 5 DEGREE LORDOTIC CAGE [PRODUCT CODE: 1878-27-409, LOT NO: ATBFD2] WAS RETURNED TO THE CUSTOMER QUALITY UNIT (CQU) FOR EVALUATION. VISUAL EXAMINATION REVEALED THAT THE CAGE HAD FRACTURED IN HALF. THE FRACTURE OCCURRED ALONG THE ENTIRE LENGTH OF THE THREADED HOLE. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. A DEFINITIVE ROOT CAUSE FOR THE CONCORDE BULLET CAGE FRACTURING IN HALF CANNOT BE POSITIVELY DETERMINED. HOWEVER, IT SHOULD BE NOTED THAT POLYMER/CARBON-FIBER CAGES ARE DESIGNED TO SUPPORT PHYSIOLOGIC LOADS. HIGHER THAN ANTICIPATED TORQUE LEVELS WHEN APPLIED TO INSERTION TOOLS, CAN CAUSE SPLITTING OR FRACTURE OF CAGES. ADDITIONALLY, AS NOTED IN THE ACCOMPANYING INSTRUCTIONS FOR USE, 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. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS REQUIRING IMMEDIATE ACTION HAVE BEEN OBSERVED, THIS COMPLAINT FILE 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(4). A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. 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

    THE REPORTED PRODUCT WAS USED IN SURGERY FOR THE FOURTH LUMBAR SPONDYLOLISTHESIS, COVERING L4-L5, ON (B)(6) 2017. SINCE THE INSERTED CAGE CONC BULLET LORD 9X9X27 5° (1878-27-409) WAS NOT FIXED AT A PROPER LOCATION, THE SURGEON TRIED TO EXPLANT AND RE-INSERT IT. HE FELT DIFFICULTY WITH MOUNTING THE INSERTER (PART NUMBER UNKNOWN), SO HE REMOVED THE CAGE WITH ONLY THE INNER SHAFT (PART NUMBER UNKNOWN) AND COMPLETED THE RE-INSERTION. ALTHOUGH HE THOUGHT SCREWS (PART NUMBER UNKNOWN) WERE SECURED ENOUGH TO FIX THE CAGE, THE THREAD SECTION OF THE CAGE BROKE. HE REMOVED THE BROKEN CAGE WITH INSTRUMENTS SUCH AS THE SPREADER, THE CHISEL, THE MUCOSA FORCEPS, AND KOCHER FORCEPS, ETC. (UNKNOWN PART NUMBERS ON ALL THOSE INSTRUMENTS). HE USED A REPLACING CAGE (THE SAME SPECIFICATIONS AS THE BROKEN ONE) AND COMPLETED THE SURGERY WITH A 40-MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235286 CONCORDE BUL LOR 9X9X27, 5 DG INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX DEPUY SYNTHES SPINE ATBFD2

    Patients

    Seq Age Sex Outcome Treatment
    1