BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TMINI MINIATURE ROBOTIC SYSTEM

    MDR report key: 25106873 · Received May 6, 2026

    Report

    Report Number
    3000719653-2026-00006
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 9, 2026
    Report Date
    May 6, 2026
    Manufacturer
    THINK SURGICAL, INC
    Product Code
    OLO
    UDI-DI
    M9461087570
    PMA / PMN Number
    K250877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    DURING THE GAP BALANCING WORKFLOW, THE SURGEON PLANNED FOR VARUS ALIGNMENT; HOWEVER, THE FINAL ALIGNMENT VALUES DISPLAYED ON THE TMINI NAVIGATION CONSOLE INDICATED VALGUS ALIGNMENT. THE SURGEON DID NOT PERFORM CUT VERIFICATION USING THE DIGITIZER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE ROBOTIC SYSTEM WITH NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509527 TMINI MINIATURE ROBOTIC SYSTEM ORTHOPEDIC STERIOTAXIC INSTRUMENT OLO THINK SURGICAL, INC 108757 M9461087570

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown