BEUDAMED
    FDA Adverse Event Death Summary report: N

    CURVE NAVIGATION 17710

    MDR report key: 12932980 · Received December 6, 2021

    Report

    Report Number
    12932980
    Event Type
    Death
    Date Received
    December 6, 2021
    Date of Event
    November 24, 2021
    Report Date
    December 1, 2021
    Manufacturer
    BRAINLAB AG
    Product Code
    OLO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DISCOVERED SCREW WAS PLACED IN T1 INSTEAD OF C7 PER MD "DUE TO INACCURACY OF IMAGE GUIDANCE SYSTEM". AN EXPERT FROM BRAIN LAB CAME ON SITE TO EVALUATE THE DEVICE WITH A MOCK SURGERY AND STATED "WORKFLOW ERROR NOT SOFTWARE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830796 CURVE NAVIGATION 17710 ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BRAINLAB AG 17710

    Patients

    Seq Age Sex Outcome Treatment
    1 22991 DA Unknown Death