BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHALIGN PLUS

    MDR report key: 8946198 · Received August 29, 2019

    Report

    Report Number
    3007521480-2019-00020
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    July 30, 2019
    Report Date
    June 7, 2021
    Manufacturer
    ORTHALIGN
    Product Code
    OLO
    UDI-DI
    00851977007901
    PMA / PMN Number
    K172462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DESPITE MULTIPLE ATTEMPTS, THE DEVICE WAS NOT RETURNED. 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.

    Additional Manufacturer Narrative · 1

    A CUSTOMER EXPERIENCE REPORT WAS SUBMITTED TO ORTHALIGN FROM A REGIONAL SALES MANAGER STATING THAT A NAVIGATION UNIT WAS SHOWING INACCURATE LEG LENGTH INFORMATION TO THE SURGEON. THE PROCEDURES WERE BELIEVE TO HAVE BEEN PROPERLY EXECUTED. ORTHALIGN FULLY EXPECTS TO RECEIVE THE NAVIGATION UNIT IN QUESTION TO INVESTIGATE. AT THIS POINT IN TIME THERE IS NO INFORMATION AVAILABLE TO COME TO A CONCLUSION AS TO WHAT MAY HAVE CAUSED THIS INACCURACY. ORTHALIGN IS FILING THIS MEDICAL DEVICE REPORT WITH ABUNDANCE OF CAUTION WITH THE KNOWLEDGE OF HOW AN INACCURATE LEG LENGTH READING HAS THE POTENTIAL TO RESULT IN PATIENT INJURY. WHEN RESULTS OF THE INVESTIGATION REGARDING THE DEVICE IN QUESTION IS COMPLETE A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    (B)(4). THE UNIT WAS GIVING VERY INACCURATE LEG LENGTH. ALL PROCEDURES WERE BELIEVED TO HAVE BEEN PROPERLY EXECUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738395 ORTHALIGN PLUS NAVIGATION UNIT OLO ORTHALIGN 403001 NA 00851977007901

    Patients

    Seq Age Sex Outcome Treatment
    1