BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHALIGN PLUS SYSTEM

    MDR report key: 12285342 · Received August 5, 2021

    Report

    Report Number
    3007521480-2019-00027
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    November 13, 2019
    Report Date
    August 5, 2021
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00858704006534
    PMA / PMN Number
    K162962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INITIAL REPORT IS BEING FILED AFTER THE DUE DATE AS THE INITIAL SUBMISSION WAS FOUND TO HAVE NOT BEEN 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 INITIAL REPORT. AN INVESTIGATION OF THE NAVIGATION UNIT AND IT'S EVENT LOG WAS PERFORMED. THE EVENT LOG WAS CORRUPTED SIGNIFYING AN ELECTRONICS ISSUE WITH THE NAVIGATION UNIT. 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 WHEN/IF ALERT LIMITS ARE EXCEEDED.

    Description of Event or Problem · 1

    AN ORTHALIGN PLUS NAVIGATION UNIT SET THE DISTAL FEMORAL VALGUS ANGLE SO FAR OFF THAT IT'S BEEN VISIBLY INCORRECT FROM A DISTANCE (15 DEGREES OR MORE). REP CHECKED AND ASSISTED NURSE WITH SET UP AND CALIBRATION, ALL STEPS FOLLOWED AS PER TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177024 ORTHALIGN PLUS SYSTEM ORTHALIGN PLUS NAVIGATION UNIT OLO ORTHALIGN, INC. 403001 00858704006534

    Patients

    Seq Age Sex Outcome Treatment
    1