BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFERENCE SENSOR 5 HIP

    MDR report key: 12697624 · Received October 26, 2021

    Report

    Report Number
    3007521480-2021-00026
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    September 13, 2021
    Report Date
    November 11, 2021
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00851977007888
    PMA / PMN Number
    K171780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D4 SERIAL # CORRECTED TO (B)(6).

    Additional Manufacturer Narrative · 1

    NO FAULT COULD BE FOUND WITH THE RETURNED REFERENCE SENSOR 5H. THE REFERENCE SENSOR PASSED ALL VISUAL AND FUNCTIONAL TESTS. 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. ORTHALIGN WILL CONTINUE TO MONITOR THIS ISSUE AND TAKE ACTION IF OR WHEN ALERT LIMITS ARE EXCEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT DOESN'T WORK. THE SENSOR WAS NOT PROVIDING ACCURATE RESULTS. THE CUPS VERSION AND ABDUCTION WAS JUST WAY OFF FROM THE STATED POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1594681 REFERENCE SENSOR 5 HIP REFERENCE SENSOR RS5H OLO ORTHALIGN, INC. 403087-06 00851977007888

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown