BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPLAN PLANNING STATION

    MDR report key: 20205948 · Received September 12, 2024

    Report

    Report Number
    3000719653-2024-00008
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    April 11, 2024
    Report Date
    September 12, 2024
    Manufacturer
    THINK SURGICAL, INC
    Product Code
    OLO
    UDI-DI
    M9461090000
    PMA / PMN Number
    K232802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE THINK SURGICAL CASE PLANNER PREPARING THE TEMPLATE FOR THIS CASE, INADVERTENTLY SELECTED THE INCORRECT IMPLANT MODEL, FROM MENU DISPLAYED IN TPLAN. THE ERROR WAS NOTICED PRIOR TO THE SURGERY AND CORRECTED. NO PAITENT INJURY REPORTED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NOTE: WE NOITCED THIS EVENT WAS NOT INCLUDED IN THE MAUDE DATABASE, AND INVESTIGATION DISCOVERED DUPLICATE MDR NUMBER, (B)(4) INITIALLY SUBMITTED ON 5/3/2024. THEREFORE, THINK SURGICAL DECIDED TO SUBMIT THIS EVENT UNDER A NEW MDR NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGICAL PLAN WAS MADE USING THE BKS TRIMAX IMPLANTS RATHER THAN THE BKS CR IMPLANTS REQUESTED BY THE SURGEON. THE OR USER NOTICED THE DIFFERENCE IN THE IMPLANT MODEL AND NOTIFIED THE SURGEON. THE SURGEON MADE THE APPROPRIATE CHANGES TO REFLECT THE CORRECT IMPLANT AND APPROVED THE PLAN. CHANGES WERE MADE BEFORE THE CASE STARTED. NO DELAY AND NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474359 TPLAN PLANNING STATION SURGICAL PLANNING STATION OLO THINK SURGICAL, INC 109000 M9461090000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown