BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORUS NAVIGATION ACCESS SYSTEM

    MDR report key: 23777703 · Received December 11, 2025

    Report

    Report Number
    23777703
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    September 29, 2025
    Report Date
    October 7, 2025
    Manufacturer
    PROVIDENCE MEDICAL TECHNOLOGY, INC.
    Product Code
    OLO
    UDI-DI
    00852776006638
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    (B)(6)-LX DISPOSABLE BROKE DURING USE. ALL PIECES WERE SEQUESTERED. ALL PIECES WERE PRESENT AND ACCOUNTED FOR. NOT AN IMPLANT BUT A DISPOSABLE ITEM NEEDED TO COMPLETE PROCEDURE. A SECOND UNIT WAS OPENED TO COMPLETE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554022 CORUS NAVIGATION ACCESS SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO PROVIDENCE MEDICAL TECHNOLOGY, INC. DX-01-160 NAS15251 00852776006638

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female