BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHALIGN PLUS SYSTEM

    MDR report key: 12099233 · Received July 1, 2021

    Report

    Report Number
    3007521480-2021-00015
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    July 6, 2020
    Report Date
    June 30, 2021
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00851977007901
    PMA / PMN Number
    K172462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF RETURNED NAVIGATION UNIT LOG FILE FOUND THE FEMORAL AXIS REGISTRATION NUMBERS WERE BEYOND TYPICAL NUMBERS. THE USER RECEIVED THE JIG OUT OF RANGE ERROR SEVERAL TIMES UNTIL THE JIG WAS RE-PINNED. THE NUMBERS INDICATE THE JIG WAS LIKELY PINNED TOO HIGH OR INCORRECTLY, THIS IS FURTHER SUPPORTED BY THE FACT THE USER SELECTED AN A/P OFFSET OF 1 WHICH IS THE MINIMUM AMOUNT. IF THE TRUE A/P OFFSET WAS A HIGHER NUMBER, THE OUTPUT WOULD HAVE BEEN CLOSER TO A NOMINAL CASE. ROOT CAUSE WAS UNABLE TO BE DETERMINED FOR THIS COMPLAINT BUT SINCE THE BEHAVIOR DESCRIBED IS SHOWN IN THE LOG FILE, THE COMPLAINT CAN BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ORTHALIGN, INC. WILL CONTINUE TO MONITOR THIS ISSUE AND TAKE ACTION IF ALERT LIMITS ARE EXCEEDED. THIS INITIAL REPORT IS BEING FILED AFTER THE DUE DATE AS THE INITIAL SUBMISSION WAS FOUND TO HAVE NOT BE RECEIVED DURING AN ATTEMPT TO SUBMIT THE FOLLOW-UP REPORT. AT THAT TIME, THE ERROR MESSAGE "ERROR: INITIAL REPORT / PRIOR SUPPLEMENT HAS NOT BEEN RECEIVED. THE INITIAL REPORT IS MISSING." ALERTED ORTHALIGN INC OF THE ISSUE PROMPTING THE SUBMISSION OF THIS AS AN INITIAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER FEMORAL REGISTRATION THE UNIT READ 24 DEGREES OF FLEXION. FEMORAL PIN WAS REINSERTED AND RANGE OF MOTION WAS REDONE. UNIT READ 15 DEGREES OF FLEXION AND THE SURGEON WAS ABLE TO ADJUST THE CUTTING BLOCK UNTIL THE UNIT READ 5 DEGREES OF EXTENSION. AFTER CUT WAS MADE THE SURGEON NOTICED THAT THE CUT "DIDNT LOOK RIGHT" AN IM GUIDE WAS USED TO REDO THE CUT. ITEM WORKED NORMALLY ON THE TIBIA AND THE CASE WAS COMPLETED WITH NO OTHER ISSUES. THE FEMORAL REGISTRATION WAS STARTED WITH THE LEG IN FLEXION. THIS WAS THE ONLY POSITION THE ALLOWED THE UNIT TO SHOW THE GREEN BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997820 ORTHALIGN PLUS SYSTEM ORTHALIGN PLUS NAVIGATION UNIT OLO ORTHALIGN, INC. 403001-05 00851977007901

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention