BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHALIGN PLUS SYSTEM

    MDR report key: 12301633 · Received August 10, 2021

    Report

    Report Number
    3007521480-2021-00020
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    December 16, 2019
    Report Date
    August 9, 2021
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00851977007888
    PMA / PMN Number
    K171780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    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 BE 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 AS AN INITIAL REPORT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. NO FAULT COULD BE FOUND WITH THE RETURNED REFERENCE SENSOR. ORTHALIGN, INC. WILL CONTINUE TO MONITOR THIS ISSUE AND TAKE ACTION WHEN/IF ALERT LIMITS ARE EXCEEDED.

    Description of Event or Problem · 1

    WHILE PERFORMING THE ACETABULAR NAVIGATION THE SURGEON;S CUP READING WAS 22/13 AFTER USING XRAY VALIDATION HE FELT THATHIS NUMBERS WERE CLOSER TO 40/13.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199446 ORTHALIGN PLUS SYSTEM REFERENCE SENSOR RS5H OLO ORTHALIGN, INC. 403087-06 00851977007888

    Patients

    Seq Age Sex Outcome Treatment
    1