BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHALIGN PLUS UNIT

    MDR report key: 14824878 · Received June 26, 2022

    Report

    Report Number
    3007521480-2022-00007
    Event Type
    Injury
    Date Received
    June 26, 2022
    Date of Event
    May 26, 2022
    Report Date
    July 28, 2022
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00851977007901
    PMA / PMN Number
    K103829
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION. ONCE THE PRODUCT IS RETURNED AN INVESTIGATION INTO THE ALLEGED ACCURACY ISSUE WILL BE PERFORMED . WITH AN ABUNDANCE OF CAUTION THIS REPORT IS BEING FILED WITH THE UNDERSTANDING OF THE POTENTIAL PATIENT HARM THAT COULD BE CAUSED TO THE PATIENT BY AN INACCURATE DEVICE MEASUREMENT.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. NO FAULT COULD BE FOUND WITH THE RETURNED NAVIGATION UNIT. THE NAVIGATION UNIT POWERED UP AND SUCCESSFULLY PASSED HORIZONTAL, VERTICAL, AND SIDE CALIBRATION. THE UNIT ALSO SUCCESSFULLY COMPLETED MULTIPLE SIMULATED MANEUVERS DURING TESTING. THE NAVIGATION UNIT WAS FOUND TO FUNCTION AS DESIGN. THE NAVIGATION LOG WAS AVAILABLE FOR REVIEW, AND IT SHOWED NINE VERY BRIEF SESSIONS BEFORE SESSION 10, WHERE THE FAILURE EVENT WAS FOUND. SESSIONS 1, 2, 3, AND 6 WERE INTERRUPTED BY BATTERY ERRORS. SESSION 5 HAD A WATCHDOG ERROR. SESSIONS 4, 7, 8, AND 9 WERE BRIEF SESSIONS WHERE THE NAV WAS POWERED ON SUCCESSFULLY, AND THE USER POWERED THE DEVICE DOWN SHORTLY AFTER. IN THE 10TH SESSION, THE NAV WAS POWERED ON AND PAIRED TO RS S/N (B)(6) AND TKA WAS PERFORMED. TIBIA SPIRIT ANGLES DISPLAYED 0 DEGREES. THE FEMUR OFFSET ANGLES WERE MEASURED AT 3.08 AND 9.05 DEGREES. THE ROOT CAUSE OF THE FAILURE WAS FOUND TO BE A BUG IN THE 4.22 SW THAT CAN CAUSE INACCURATE VALUES. SOFTWARE DESIGN IMPROVEMENTS FOR THE ORTHALIGN PLUS UNIT HAVE BEEN INITIATED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FEMORAL AND TIBIA CUTS WERE MADE USING THE ORHALIGN COMPUTER. AFTER COMPLETION OF CUTS THE SURGEON THOUGHT THE TIBIA CUT LOOKED LIKE IT HAD AN ANTERIOR SLOPE OF AROUND 10 DEGREES (THE JIG WAS DIALED TO ZERO DEGREES V/V AND ZERO DEGREES POSTERIOR SLOPE). HE ALSO THOUGHT THE FEMORAL CUT WAS IN TOO MUCH FLEXION + IN VARUS (JIG WAS SET TO ZERO GEGREES V/V AND 3 DEGREES FEM FLEXION). TIBIA HAD TO BE RECUT WITH EXTRAMEDULLARY GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608969 ORTHALIGN PLUS UNIT NAVIGATION UNIT OLO ORTHALIGN, INC. 403001-08 210731018LS 00851977007901

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention