BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHALIGN PLUS SYSTEM

    MDR report key: 14042997 · Received April 7, 2022

    Report

    Report Number
    3007521480-2022-00002
    Event Type
    Injury
    Date Received
    April 7, 2022
    Date of Event
    March 8, 2022
    Report Date
    September 26, 2022
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00810832031369
    PMA / PMN Number
    K200642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE NAVIGATION LOG WAS AVAILABLE FOR REVIEW. THE FIRST SESSION SHOWED THE NAV WAS PAIRED WITH RS S/N (B)(6) AND THE TKA PROCEDURE WAS COMPLETED. UPON PAIRING WITH THE RETURNED NAV UNIT, THE RS S/N (B)(6) SHOWED A USE COUNT OF 121. REGISTRATION WAS COMPLETED WITH THE FEMUR OFFSET ANGLE AND RESECTION ANGLE FOUND TO BE WITHIN TOLERANCE. DURING TIBIAL REGISTRATION, THE ERROR MESSAGE "TIBIA - MOUNT SIDE SWITCHING WARNING" APPEARED, WHICH MEANS THE RS WAS REMOVED FROM THE INTRUMENT AND PLACED ON THE OPPOSITE SIDE. SHORTLY AFTER THE WARNING, COMMUNICATION WAS LOST WITH THE RS, AND THE NAV WAS POWERED DOWN. THE ANGLE OF FLEXION IS MEASURED BY THE REFERENCE SENSOR, AND THIS DATA IS COMMUNICATED TO THE NAV UNIT. IT IS SUSPECTED THAT THE REFERENCE SENSOR S/N (B)(6) , WHICH WAS FOUND IN THE NAVIGATIONAL LOG, MAY HAVE EXPERIENCED AGE-RELATED GYRO BIAS DUE TO ITS HIGH USE COUNT. THE RS WAS NOT RETURNED FOR INVESTIGATION. 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. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE

    Additional Manufacturer Narrative · 0

    AT THIS TIME THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION. ONCE THE PRODUCT IS RETURNED ORTHALIGN WILL PERFORM AN INVESTIGATION INTO THE ALLEGED ACCURACY ISSUE. ORTHALIGN IS FILING THIS MDR WITH AN ABUNDANCE OF CAUTION WITH THE UNDERSTANDING OF THE POTENTIAL HARM THAT THE PATIENT COULD BE SUBJECT TO IF THE DEVICE PRODUCES INACCURATE MEASUREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED AND COMPONENTS WERE SUBMITTED IN PLACE. THE PHYSICIAN NOTICED A LARGE GAP IN THE LATERAL COMPARTMENT OF THE KNEE. HE HAD CONCERNS THAT THE UNIT MAY HAVE MALIGNED THE FEMUR, AND WANTED REVIEW OF THE DEVICE. THE COMPUTER WAS TAKEN OFF THE FIELD AND IT READ, "NAVIGATION UNIT ERROR, REPLACE WITH NEW NAV. UNIT, RETURN THIS UNIT... STUCK KEY 4."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2341291 ORTHALIGN PLUS SYSTEM ORTHALIGN PLUS NAVIGATION UNIT OLO ORTHALIGN, INC. 403001-08 210811020LS 00810832031369

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention