BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXTAR SPINE

    MDR report key: 18992780 · Received March 28, 2024

    Report

    Report Number
    3005180920-2024-00229
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Report Date
    March 28, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OLO
    PMA / PMN Number
    K223769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACCURACY OF THE NEXTAR SPINE SYSTEM HAS BEEN FULLY VALIDATED AND ALL RELEVANT DATA HAS BEEN PROVIDED TO FDA WITHIN THE 510K SUBMISSION (K210859 AND K223769). REGISTRATION OF CT SCANS CAN BE INFLUENCED BY THE CT MACHINE INSTALLED AT THE TREATMENT FACILITY. WITHIN THE NEXTAR SPINE SOFTWARE ITSELF THERE ARE NO DEFICIENCIES IDENTIFIED REGARDING THE ABILITY TO REGISTER CT SCANS AND ALL POTENTIALLY RELATED COMPLAINTS HAVE BEEN EVALUATED FOR THIS POINT. THE DEVICE LABELING PROVIDES THE NECESSARY INFORMATION FOR CT SCAN SETTINGS AND THERE ARE NO UNRESOLVED COMPLAINTS WITHIN THE MEDACTA SYSTEM FOR THIS SUBJECT. IN RESPONSE TO THE ASSERTION THAT A SURGEON "...HAD NUMEROUS SURGERIES DELAYED AND INSTRUMENTS FAIL DURING SURGERY..." WE HAVE EVALUATED ALL OUR DATA AND COMPLAINT RECORDS, AND THIS COMMENT DOES NOT CORRELATE WITH ANY REGISTERED USERS OF THE SYSTEM. THERE HAVE BEEN SOME INSTRUMENT ISSUES DETECTED, AND EACH CASE HAS BEEN FULLY INVESTIGATED IN OUR COMPLAINT SYSTEM WITH A RESPONSE PROVIDED TO THE REPORTER UPON CLOSURE OF THE INVESTIGATION PROCESS. AMONG THE CASES EVALUATED, 3 WERE IDENTIFIED AS BEING REPORTABLE TO FDA, AND THE REPORTS WERE SUBMITTED IN COMPLIANCE PER OUR QUALITY SYSTEM (MDR NUMBERS: 3005180920-2024-00023, 3005180920-2023-00841, AND 3005180920-2023-01111). FOR THE ASSERTION THAT MEDACTA IS "COVERING UP FAILURES", WE HAVE CONDUCTED AN INTERNAL INVESTIGATION AND CONCLUDE THAT THIS IS 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 ((B)(6) 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 ((B)(6) 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 NO UNREPORTED ISSUES HAVE BEEN DETECTED.

    Description of Event or Problem · 0

    A MEDWATCH (MW5151929) REPORT WAS ANONYMOUSLY SUBMITTED TO FDA REPORTING AN INACCURACY OF THE NEXTAR SPINE SYSTEM. DESCRIPTION REPORTED IN THE FDA REPORT: NEXTAR SPINE SYSTEM IS INACCURATE. IT DOES NOT REGISTER CORRECTLY WITH CT SCANS AS ADVERTISED. THE SYSTEM DOES NOT WORK FOR MANY CT SCANS SETTINGS. THE SALES TEAM IS ACTIVELY MISLEADING SPINE SURGEONS. THE SYSTEM SHAKES DURING USE SO PREVENTS ACCURATE TRACKING AND GUIDANCE. MY SURGEON HAD NUMEROUS SURGERIES DELAYED AND INSTRUMENTS FAIL DURING SURGERY AND THE COMPANY DID NOT PROPERLY HANDLE THE COMPLAINT. THE COMPANY LAUNCHED A SYSTEM THAT DOES NOT WORK AND IS COVERING UP FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716436 NEXTAR SPINE NEXTAR SPINE OLO MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other