BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHALIGN PLUS UNIT

    MDR report key: 10786293 · Received November 4, 2020

    Report

    Report Number
    3007521480-2020-00013
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    October 5, 2020
    Report Date
    June 3, 2021
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00851977007901
    PMA / PMN Number
    K171780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT WHEN NAVIGATING THE CUP THE VERSION AND ABDUCTION OUTPUTS WERE INCORRECT. THE VERSION OF THE CUP AND ABDUCTION WERE CONFIRMED TO BE CORRECT BY THE SURGEON INTRAOPERATIVELY USING C-ARM. ONCE THE PRODUCT IS RETURNED, ORTHALIGN, INC. 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

    IT WAS REPORTED THAT WHEN NAVIGATING THE CUP THE VERSION AND ABDUCTION OUTPUTS WERE COMPLETELY INCORRECT. THE VERSION OF THE CUP AND ABDUCTION WERE CONFIRMED TO BE CORRECT BY THE SURGEON INTRAOPERATIVELY USING C-ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251384 ORTHALIGN PLUS UNIT NAVIGATION UNIT OLO ORTHALIGN, INC. 403001-05 00851977007901

    Patients

    Seq Age Sex Outcome Treatment
    1