BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHALIGN PLUS SYSTEM

    MDR report key: 12457218 · Received September 10, 2021

    Report

    Report Number
    3007521480-2021-00024
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Date of Event
    August 11, 2021
    Report Date
    December 9, 2021
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00810832030089
    PMA / PMN Number
    K172462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE RETURNED NAVIGATION UNIT EVENT LOG SHOWS THAT DURING THE PROCEDURE, THE "REFERENCE SENSOR UNSTABLE IN COMM CHECK" MESSAGE WAS DISPLAYED AND THE DATA RECEIVED FROM THE RS5 WAS ABNORMAL. AN INSPECTION OF THE RETURNED NAVIGATION UNIT AND REFERENCE SENSOR WAS CONDUCTED AND BOTH DEVICES PERFORMED AS DESIGNED. THE ROOT CAUSE IS LIKELY DUE TO DAMAGED ELECTRONICS INSIDE THE REFERENCE SENSOR RESULTING IN THE UNSTABLE COMMUNICATION. 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

    AT THIS TIME THERE IS NO KNOWN INJURY TO THE PATIENT. 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 COULD BE CAUSED TO THE PATIENT BY AN INACCURATE DEVICE MEASUREMENT.

    Description of Event or Problem · 1

    THE SURGEON STATED THAT THE NUMBERS SEEMED REVERSED FOR ABDUCTION AND VERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351238 ORTHALIGN PLUS SYSTEM ORTHALIGN PLUS NAVIGATION UNIT OLO ORTHALIGN, INC. 403001 00810832030089

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown