BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXTAR AUGMENTED REALITY NAVIGATION SYSTEM

    MDR report key: 18778221 · Received February 23, 2024

    Report

    Report Number
    MW5151929
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Report Date
    January 25, 2024
    Manufacturer
    MEDACTA USA, INC.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    NEXTAR SPINE SYSTEM IS INACCURATE. DOES NOT REGISTER CORRECTLY WITH CT SCANS AS ADVERTISED. THE SYSTEM DOES NOT WORK FOR MANY CT SCAN SETTINGS. THE SALES TEAM IS ACTIVELY MISLEADING SPINE SURGEONS. THE SYSTEM IS NOT ACCURATE AS ADVERTISED, 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 DOESN'T WORK AND IS COVERING UP FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2001636 NEXTAR AUGMENTED REALITY NAVIGATION SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDACTA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown