BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTALIF ANT - LAG

    MDR report key: 19095810 · Received April 12, 2024

    Report

    Report Number
    3005180920-2024-00202
    Event Type
    Malfunction
    Date Received
    April 12, 2024
    Report Date
    April 12, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OVD
    PMA / PMN Number
    K221545
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAFETY AND RELIABILITY OF THE MECTALIF ANTERIOR LAG SCREW SYSTEM HAS BEEN FULLY VALIDATED AND ALL RELEVANT DATA HAS BEEN PROVIDED TO FDA WITHIN THE 510K SUBMISSIONS (K221545 AND K232123). IT IS FULLY VERIFIED THAT THIS PRODUCT DOES NOT "FAIL BASIC QUALITY TESTS" AS ASSERTED IN THE MEDWATCH AND THERE ARE NO NONCONFORMING PRODUCTS RELEASED ON THE MARKET. ONE SAFETY RELATED RECALL HAS BEEN EXECUTED AND REPORTED TO FDA (Z-1404-2023, EVENT ID 91947). THE CORRECTIVE ACTIONS HAVE BEEN COMPLETED AND COMMUNICATED TO OUR RECALL COORDINATOR (MARIE FINK OF THE NEW ORLEANS DISTRICT) AND THE CHANGES IMPLEMENTED HAVE BEEN CLEARED WITH K232123. AMONG THE COMPLAINT RECORDS OF MEDACTA, TWO CASES WERE IDENTIFIED AS BEING REPORTABLE TO FDA AT THE TIME OF THIS WRITING, AND THE REPORTS WERE SUBMITTED IN COMPLIANCE PER OUR QUALITY SYSTEM (MDR NUMBERS: 3005180920-2023-00191 AND 3005180920-2023-00193). BOTH REPORTS RELATE TO THE COMPLETED RECALL REFERENCED ABOVE. IN RESPONSE TO THE ASSERTION THAT MEMBERS OF THE MEDACTA TEAM HAVE "ACTIVELY CONSPIRED" TO "COVER UP" PROBLEMS REPEATEDLY, MEDACTA'S GENERAL COUNSEL HAS CONDUCTED AN INTERNAL INVESTIGATION, WITH FULL COOPERATION OF THE PERSONS NAMED, FINDING NO BASIS TO SUPPORT ANY OF THE ALLEGATIONS WHICH HAVE BEEN MADE, AND CONFIDENTLY CONCLUDING THAT THE ALLEGATIONS ARE COMPLETELY UNFOUNDED. WE CONFIRM THE EFFECTIVENESS OF OUR SYSTEMATIC ATTAINMENT OF ALL ADVERSE EVENTS AND PRODUCT FAILURES, WITH CONSISTENT MANAGEMENT WITHIN OUR COMPLAINT HANDLING PROCESS. OUR COMPLAINT SOFTWARE AUTOMATICALLY ENSURES THAT WE PROVIDE FEEDBACK TO THE PERSON REGISTERING EACH COMPLAINT, BOTH AT THE TIME OF REGISTRATION AND UPON CLOSURE OF THE INVESTIGATION. THE PROCESS IS CONDUCTED TRANSPARENTLY AND IN FULL COMPLIANCE, AND THIS IS WELL DEMONSTRATED BY THE REPORTING WE HAVE PROVIDED TO FDA, AS REFERENCED ABOVE. AS FURTHER TESTAMENT TO OUR COMPLIANCE, MEDACTA INTERNATIONAL HAS RECENTLY COMPLETED OUR MDSAP AND ISO 13485 ANNUAL AUDIT WITH BSI (MARCH 5 - 14, 2024), AT THE RE-CERTIFICATION LEVEL, AND ZERO NONCONFORMITIES WERE RAISED RESPECTIVE TO THE ENTIRE SCOPE OF THE AUDIT, INCLUDING A FULL REVIEW OF THE COMPLAINT HANDLING AND ADVERSE EVENT REPORTING PROCESSES. ADDITIONALLY, MEDACTA USA IS ISO 13485 CERTIFIED AND WAS ALSO RECENTLY RECERTIFIED BY BSI (JANUARY 15 - 16, 2024) WITH ZERO NONCONFORMITIES RAISED ACROSS THE FULL SCOPE OF THE AUDIT, INCLUDING THE PROCESSES OF COMPLAINT COMMUNICATION AND REPORTING. IN CONCLUSION, FOLLOWING THIS MEDWATCH, MEDACTA HAS RE-EVALUATED ALL SURGEON FEEDBACK AND WE CONFIRM THAT ALL COMPLAINTS ARE PROPERLY ACCOUNTED FOR WITHIN THE COMPLAINT HANDLING PROCESS.

    Description of Event or Problem · 0

    THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) RECEIVED A MEDICAL DEVICE REPORT CONCERNING MEDACTA PRODUCT VIA THE MEDWATCH (MW5151934) PROGRAM: THE MECTALIF ANTERIOR LAG SCREW SYSTEM HAS HAD NUMEROUS PRODUCT DEFECTS, MALFUNCTIONS, AND ISSUES THAT HAVE DIRECTLY CAUSED ADVERSE EFFECTS TO MY PATIENTS. THIS PRODUCT HAS ALREADY BEEN RECALLED BY MEDACTA ONCE, AND YET THE PRODUCT CONTINUES TO ENDANGER MY PATIENTS AND FAIL BASIC QUALITY TESTS. THE MEDACTA INTERNATIONAL SPINE ENGINEERING TEAM DOES NOT ADDRESS THESE PROBLEMS AND HAS ACTIVELY CONSPIRED WITH THE MEDACTA USA SPINE TEAM TO COVER UP THESE PROBLEMS REPEATEDLY. THE COLLECTIVE MEDACTA TEAMS HAVE REPEATEDLY PUSHED MYSELF AND OTHER SPINE SURGEONS (ORTHOPAEDIC SPINE AND/OR NEUROSURGEONS) TO USE THIS PRODUCT WHILE ACTIVELY KNOWING THAT THIS PRODUCT IS DEFECTIVE. IT IS MY UNDERSTANDING THAT SEVERAL MEDACTA USA SPINE EMPLOYEES HAVE EITHER QUIT AND/OR BEEN TERMINATED BECAUSE THEY REPORTED THIS PROBLEM TO SENIOR LEADERSHIP, WHO PROMPTLY PUSHED THESE INDIVIDUALS OUT AND CONTINUED TO SELL THIS PRODUCT. THIS PRODUCT AND SUBSEQUENT TEAMS HAVE REPEATEDLY ENDANGERED MY PATIENTS' LIVES AND MY SURGICAL PRACTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769864 MECTALIF ANT - LAG MECTALIF ANT - LAG OVD MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other