BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE BUL LOR 9X8X27, 5 DG

    MDR report key: 8254303 · Received January 16, 2019

    Report

    Report Number
    1526439-2019-51235
    Event Type
    Malfunction
    Date Received
    January 16, 2019
    Date of Event
    December 14, 2018
    Report Date
    December 19, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MAX
    UDI-DI
    10705034140056
    PMA / PMN Number
    K041722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). UDI: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. VISUAL EXAMINATION OF THE CAGE FEATURES TWO VERTICAL FRACTURES ALIGNED WITH THE MIDDLE OF THE CAGE THAT START AT THE CAGE¿S PROXIMAL END AND TRAVEL INWARDS UNTIL REACHING THE OPEN CENTER OF THE CAGE. NO MATERIAL HAS BROKEN OFF FROM THE CAGE AND THE CAGE HAS NOT FRACTURED INTO MULTIPLE PIECES. THERE IS SOME WEAR TO THE THREADS, BUT IT IS LARGELY SUPERFICIAL AND NOT BELIEVED TO HAVE INFLUENCED THE FUNCTIONALITY OF THE DEVICE, THOUGH IS A SIGN OF ITS USAGE AND STRESSES EXPERIENCED. THE FRACTURE HAS PASSED THROUGH THE THINNEST SECTION OF THE CAGE. BASED ON THESE OBSERVATIONS, IT IS BELIEVED THAT THE CAGE EXPERIENCED HIGH ENOUGH STRESSES DURING IMPACTION TO RESULT IN IT FRACTURING. 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. ALL COMPLAINT TRENDS WILL BE EVALUATED AS A PART OF THE DEPUY SPINE MONTHLY COMPLAINT REVIEW MEETING. THE ROOT CAUSE OF THE CAGE BREAKING CANNOT BE DETERMINED FROM THE SAMPLE AND THE INFORMATION PROVIDED. A POTENTIAL ROOT CAUSE MAY BE HIGH FORCES INADVERTENTLY PLACED ON THE CAGE DURING IMPACTION, EXERTING ENOUGH FORCE TO RESULT IN THE FRACTURE. 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 WERE FOUND, 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 · 0

    PRODUCT COMPLAINT #: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGERY WAS PERFORMED ON (B)(6) 2018 TO FIX L5/S. DURING THE SURGERY, THE SURGEON CORRECTED THE CAGE POSITION BECAUSE THE CAGE POSITION WAS SIFTED. THEN, IT WAS REPORTED THE SURGEON RECOGNIZED THAT THE CAGE WAS BROKEN (SMALL CRACK) WHEN THE SURGEON REMOVED THE SIFTED CAGE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46299 CONCORDE BUL LOR 9X8X27, 5 DG INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDOS INTERNATIONAL SàRL CH 148617 10705034140056

    Patients

    Seq Age Sex Outcome Treatment
    1