BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANTERN SURGICAL ASSISTANT

    MDR report key: 14824885 · Received June 26, 2022

    Report

    Report Number
    3007521480-2022-00006
    Event Type
    Malfunction
    Date Received
    June 26, 2022
    Date of Event
    April 27, 2022
    Report Date
    June 26, 2022
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00810832031406
    PMA / PMN Number
    K200892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING INVESTIGATION OF RETURNED NAVIGATION UNIT THE TESTER USED AN ORTHALIGN MECHANICALLY FABRICATED FEMORAL PLATFORM, THE NAVIGATIONAL UNIT AND IN-HOUSE RS WERE ATTACHED AND THE FEMORAL MANEUVER WAS PERFORMED THREE TIMES. THE ERROR FROM THE EXPECTED VALUE WAS 0.5 DEGREES OR LESS FOR EACH TEST IN BOTH FLEXION/EXTENSION AND VARUS/VALGUS. AN ADDITIONAL TEST ON SAWBONES WAS PERFORMED TO NAVIGATE THE FEMORAL RESECTION PLANE TO 3.5 DEGREES, AS DESCRIBED IN THE COMPLAINT. A FEMORAL MANEUVER WAS PERFORMED AND THE RESECTION WAS DIALED TO 3.5 DEGREES OF FLEXION. THE ORTHALIGN ENGINEER VERIFIED THE IMAGE ON THE SCREEN WITH THE RESECTION LINE MATCHED THE OUTPUT. THE ENGINEER CONFIRMED THE CUTTING BLOCK WAS AIMED IN FLEXION, THE SOFTWARE DISPLAYED FLEXION, AND THE RESECTION LINE ON THE SOFTWARE IMAGE WAS ALSO IN FLEXION. A REVIEW OF THE LOG FILES REVEALED NO ANOMALIES OR ERRORS. THE USER DID NOT REGISTER THE ANGLES THEY NAVIGATED TO ON THE SCREEN, SO THE TARGET NUMBERS WERE UNABLE TO BE VERIFIED. A POTENTIAL ROOT CAUSE FOR THIS ISSUE COULD BE IMPROPER FEMORAL MANEUVER TECHNIQUE. THIS WOULD EXPLAIN THE BEHAVIOR SEEN BY THE USER. THE MANUEVER MUST BE PERFORMED AS DESCRIBED IN THE SURGICAL TECHNIQUE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ORTHALIGN FLEXION CUT WAS GOING TO BE WAY OFF. WANTED FOUR DEGREES. WAS GETTING 18-20 DEGREES. SO, WE WENT TO THE MANUAL IM GUIDE FOR DISTAL FEMUR AND PROXIMIAL TIBIA. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171590 LANTERN SURGICAL ASSISTANT NAVIGATION UNIT OLO ORTHALIGN, INC. 406000-01 21111807LS 00810832031406

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown