BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNEEALIGN 2

    MDR report key: 12097329 · Received June 30, 2021

    Report

    Report Number
    3007521480-2021-00009
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    July 3, 2019
    Report Date
    June 29, 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 · 1

    THE RETURNED REFERENCE SENSOR WAS FUNCTIONALLY TESTED USING AN IN-HOUSE NAVIGATION UNIT. THE REFERENCE SENSOR SUCCESSFULLY PERFORMED SIMULATED PROCEDURES BY PERFORMING BACK TABLE CALIBRATION AND SIMULATED PROCEDURES USING SAW BONES. THE REFERENCE SENSOR WAS FOUND TO FUNCTION AS DESIGNED. 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

    SURGEON FEEDBACK THAT THE KNEE CUT WAS VALGUS AFTER CHECKING X RAY (POST-OP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987027 KNEEALIGN 2 REFERENCE SENSOR OLO ORTHALIGN, INC. 133632 00858704006015

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention