BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHALIGN PLUS

    MDR report key: 10936498 · Received December 2, 2020

    Report

    Report Number
    3007521480-2020-00017
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 3, 2020
    Report Date
    April 5, 2021
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00851977007888
    PMA / PMN Number
    K200642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO FAULT COULD BE FOUND WITH THE RETURNED REFERENCE SENSOR 5 HIP (RS5H), PART # 403087-06, SERIAL # (B)(6). THE RS PASSED ALL VISUAL AND FUNCTIONAL TESTS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED. NO PROCESS DEVIATIONS OR NON-CONFORMING MATERIAL REPORTS WITHIN THE DHR. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ORTHALIGN, INC. WILL CONTINUE TO MONITOR THIS ISSUE AND TAKE ACTION IF/WHEN ALERT LIMITS ARE EXCEEDED. CORRECTION TO THE 510(K) REFERENCE ALSO INCLUDED IN THIS FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THERE IS NO KNOWN INJURY TO THE PATIENT. 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 COULD BE CAUSED TO THE PATIENT BY AN INACCURATE DEVICE MEASUREMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNITS HAVE CAUSED IN ACCURATE READINGS. THE SURGEON WAS UNABLE TO NAVIGATE THE CUP. WE ARE UNSURE OF WHICH UNIT HAVE BEEN CAUSING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397792 ORTHALIGN PLUS REFERENCE SENSOR OLO ORTHALIGN, INC. 403087-06 00851977007888

    Patients

    Seq Age Sex Outcome Treatment
    1