BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMINI MINIATURE ROBOTIC SYSTEM

    MDR report key: 24280651 · Received February 6, 2026

    Report

    Report Number
    3000719653-2026-00002
    Event Type
    Injury
    Date Received
    February 6, 2026
    Date of Event
    January 7, 2026
    Report Date
    February 6, 2026
    Manufacturer
    THINK SURGICAL, INC
    Product Code
    OLO
    UDI-DI
    M9461087570
    PMA / PMN Number
    K253661
    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

    THE EVENT IS UNDER INVESTIGATION TO DETERMINE THE CAUSE OF THE REPORTED FEMORAL NOTCHING. THE INVESTIGATION WILL EVALUATE FACTORS INCLUDING, BUT NOT LIMITED TO, SURGICAL PLANNING AND DEVICE USE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION, IF REQUIRED.

    Description of Event or Problem · 0

    FEMORAL NOTCHING WAS IDENTIFIED INTRA-OPERATIVELY, AND ADDITIONAL IMPLANTS (STEMS AND SCREWS) WERE UTILIZED ADDRESS THE FINDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183487 TMINI MINIATURE ROBOTIC SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO THINK SURGICAL, INC 108757 M9461087570

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention