BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHALIGN PLUS

    MDR report key: 8584229 · Received May 6, 2019

    Report

    Report Number
    3007521480-2019-00011
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Date of Event
    April 8, 2019
    Report Date
    June 30, 2021
    Manufacturer
    ORTHALIGN INC.
    Product Code
    OLO
    UDI-DI
    00851977007901
    PMA / PMN Number
    K171780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DESIGN HISTORY FILE WAS PERFORMED BY A TRAINED ORTHALIGN, INC. EMPLOYEE. THE RESULTS OF THIS REVIEW INDICATED THAT THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO COMMERCIAL RELEASE. THE PRODUCT WAS DISCARDED AFTER USE AND NOT RETURNED TO ORTHALIGN, INC. AND THEREFORE A FAILURE ANALYSIS COULD NOT BE PERFORMED AND THE COMPLAINT COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    AN ORTHALIGN DISTRIBUTOR REPORTED THAT THE SECOND NAVIGATION UNIT THAT THE SURGEON ATTEMPTED TO USE GAVE A FLEXION READING OF 11 DEGREES. THIS WAS AGAIN AN EXTREME ANGLE THAT THE SURGEON KNEW WAS INCORRECT. ORTHALIGN'S REPRESENTATIVE NOTED THAT THIS PARTICULAR SURGEON HAS DONE HUNDRES OF CASES AND KNOW THIS. ORTHALIGN PLUS UNITS HAVE BEEN CLEARED BY THE FDA WITH THE CLAIM OF +/- 3 DEGREES. THIS NAVIGATION UNIT WAS DISCARDED AFTER USE. AN INVESTIGATION INTO THE DHR FOR THIS DEVICE WILL BE PREFORMED AND A FOLLOW UP REPORT WILL GENERATED AND SUBMITTED. WITH AN ABUNDANCE OF CAUTION THIS REPORT IS BEING FILED WITH THE UNDERSTANDING OF THE POTENTIAL PATIENT HARM THAT COULD RESULT FROM AN ACCURACY MALFUNCTION OF THIS MAGNITUDE. A FOLLOW UP REPORT WILL BE FILED WITH THE INVESTIGATION FINDINGS.

    Description of Event or Problem · 1

    NAVIGATION UNIT ((B)(4)) GAVE A FLEXION READING OF 11 DEGREES, EXTREME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375220 ORTHALIGN PLUS NAVIGATION UNIT OLO ORTHALIGN INC. 403001-05 NA 00851977007901

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention