BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHALIGN PLUS SYSTEM

    MDR report key: 12294353 · Received August 9, 2021

    Report

    Report Number
    3007521480-2021-00023
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    February 27, 2020
    Report Date
    August 5, 2021
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00851977007901
    PMA / PMN Number
    K172462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF RETURNED NAVIGATION UNIT LOG FILE FOUND A SIGNIFICANT CHANGE IN CUP VALUES WERE DISPLAYED AFTER THE CUP WAS IMPACTED. THE ROOT CAUSE OF THIS ISSUE IS NAVIGATING THE CUP WITH THE SENSOR ATTACHED TO THE IMPACTOR WHILE IMPACTING. ORTHALIGN DOES NOT RECOMMEND NAVIGATING DURING IMPACTION, IT CAN CAUSE DAMAGE AND LOSS OF NAVIGATION ACCURACY. ORTHALIGN RECOMMENDS NAVIGATING, TAKING THE SENSOR OFF THE IMPACTOR, THEN IMPACTING. AFTER IMPACTION, THE "CHECK CUP" FEATURE CAN BE UTILIZED TO VERIFY RESULTS. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TOTAL HIP ARTHROPLASTY WAS PERFORMED WITH HIPALIGN IN THE MORNING WITH THE NAVIGATION UNIT AND REFERENCE SENSOR. WHILE THE SURGEON WAS IMPACTING CUP, ABDUCTION ANGLES WAS BIGGER AND BIGGER SUCH AS FROM 60 TO 70 DEGREES. HE IMPACTED THE CUP AGAIN, ANGLES THE NAVIGATION SHOWED WAS PROPER SUCH AS 40 DEGREE AND 15 DEGREE. THE ONLY ABDUCTION ANGLES BECAME BIGGER WHEN IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191331 ORTHALIGN PLUS SYSTEM ORTHALIGN PLUS NAVIGATION UNIT OLO ORTHALIGN, INC. 403001-05 00851977007901

    Patients

    Seq Age Sex Outcome Treatment
    1