BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHALIGN PLUS SYSTEM

    MDR report key: 12059056 · Received June 24, 2021

    Report

    Report Number
    3007521480-2021-00008
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    May 19, 2021
    Report Date
    September 10, 2021
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00851977007901
    PMA / PMN Number
    K171780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE ROOT CAUSE ACCORDING TO THE NAV UNIT OPERATIONAL LOG FILE IS MOST LIKELY DUE TO THE RS5 SENSOR UNSTABLE IN COMM CHECK AND THE DATA RECEIVED FROM THE RS5 WAS ABNORMAL. DURING FUNCTIONAL TESTING, BOTH THE RS5 AND NAV. UNIT WORKED AS INTENDED. ORTHALIGN, INC. WILL CONTINUE TO MONITOR THIS ISSUE AND TAKE ACTION WHEN/IF ALERT LIMITS ARE EXCEEDED.

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION. 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 THE PATIENT COULD BE SUBJECT TO IF THE DEVICE PRODUCES INACCURATE MEASUREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TOTAL HIP ARTHROPLASTY WAS PERFORMED WITH HIPALIGN. CUP ANGLES, ESPECIALLY ABDUCTION CHANGED A LOT AFTER CUP IMPACTION. THE ANTEVERSION ANGLE ALSO CHANGED AS WELL. HE CONFIRMED FIXATION OF THE UNIT AND THE REFERENCE SENSOR BUT NO LOOSE WAS FOUND AT THAT TIME. SUBSEQUENTLY, HE COMPLETED THE SURGERY WITH ANGLES THE NAVIGATION FIRSTLY SHOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958583 ORTHALIGN PLUS SYSTEM ORTHALIGN PLUS NAVIGATION UNIT OLO ORTHALIGN, INC. 403001-05 00851977007901

    Patients

    Seq Age Sex Outcome Treatment
    1