BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAINLAB NAVIGATION SYSTEM

    MDR report key: 18290797 · Received December 8, 2023

    Report

    Report Number
    18290797
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Date of Event
    July 24, 2023
    Report Date
    October 25, 2023
    Manufacturer
    BRAINLAB AG
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING CRANIOTOMY, C1 DRILL BIT USED. NOTED THIS WAS PLACED INTO THE B1 GUARD. DESIGNS/COLORATION OF BITS AND GUARDS ARE VERY SIMILAR. A PIECE OF THE BIT WAS FOUND TO BE RETAINED ON POST-OP MRI AND REQUIRED WOUND TO BE WASHED OUT AND DRILL BIT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258992 BRAINLAB NAVIGATION SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BRAINLAB AG

    Patients

    Seq Age Sex Outcome Treatment
    1 15330 DA Female Other