BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TMINI MINIATURE ROBOTIC SYSTEM

    MDR report key: 23248719 · Received October 8, 2025

    Report

    Report Number
    3000719653-2025-00012
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    September 9, 2025
    Report Date
    October 3, 2025
    Manufacturer
    THINK SURGICAL, INC
    Product Code
    OLO
    PMA / PMN Number
    K250877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A THOROUGH REVIEW OF THE TPLAN AND NAVIGATION CONSOLE LOG FILES CONFIRMED THAT SEGMENTATION, REGISTRATION, AND PIN PLACEMENT WERE EXECUTED ACCORDING TO PLAN. NO NOTCH WARNINGS WERE ISSUED BY THE SYSTEM IN EITHER TPLAN OR THE NAVIGATION CONSOLE BASED ON THE AVAILABLE DATA, A DEFINITIVE ROOT CAUSE FOR FEMORAL NOTCHING COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    POST-OPERATIVELY FEMORAL NOTCHING WAS IDENTIFIED, AND A REVISION SURGERY WAS PERFORMED TO CORRECT THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2513466 TMINI MINIATURE ROBOTIC SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO THINK SURGICAL, INC 109343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention