BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNEEALIGN 2 SYSTEM

    MDR report key: 10186640 · Received June 23, 2020

    Report

    Report Number
    3007521480-2020-00008
    Event Type
    Injury
    Date Received
    June 23, 2020
    Date of Event
    November 11, 2019
    Report Date
    June 11, 2021
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00858704006015
    PMA / PMN Number
    K163379
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION OF THE RETURNED REFERENCE SENSOR FOUND THE HOUSING HAD BROKEN WHERE THE MOUNTING BRACKET IS ATTACHED; THIS CAUSED AN ANGULAR OFFSET WHICH RESULTED IN INCORRECT REGISTRATION ANGLES. MOLD REDESIGN IMPROVEMENTS FOR THE REFERENCE SENSOR 2 HAVE BEEN INITIATED TO ADDRESS THE ROOT CAUSE. 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.

    Additional Manufacturer Narrative · 1

    A FEMUR OSTEOTOMY WAS PERFORMED PER ANGLES PROVIDED BY THE KNEEALIGN 2 SYSTEM AS THE SENSOR COULDN'T REGISTER THE HIP ROTATION ACCURATELY, RESULTED IN VALGUS CUT OF THE FEMUR. 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 THE SENSOR COULDN'T REGISTER THE HIP ROTATION ACCURATELY. RESULTED IN VALGUS CUT ON THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649883 KNEEALIGN 2 SYSTEM REFERENCE SENSOR OLO ORTHALIGN, INC. 133632 00858704006015

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention