BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNEEALIGN 2

    MDR report key: 11120908 · Received January 5, 2021

    Report

    Report Number
    3007521480-2021-00001
    Event Type
    Injury
    Date Received
    January 5, 2021
    Date of Event
    November 30, 2020
    Report Date
    November 12, 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

    CORRECTED DATA: D4 NI. D9. NO. H3 NOT RETURNED TO MANUFACTURER. H4 NI. H6 CODES. TYPE OF INVESTIGATION: 4114. INVESTIGATION FINDINGS: 3221. INVESTIGATION CONCLUSIONS: 4315. H10 AT THIS TIME THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION. 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 THE PATIENT COULD BE SUBJECT TO IF THE DEVICE PRODUCES INACCURATE MEASUREMENTS.

    Additional Manufacturer Narrative · 0

    DURING TESTING THE RETURNED REFERENCE SENSOR 2 WAS FOUND TO FAIL BACK TABLE CALIBRATION DUE TO A BROKEN PLASTIC TAB THAT HOLDS THE METAL BRACKET CAUSING A MISALIGNMENT WITH THE NAVIGATION UNIT. THIS MISALIGNMENT LIKELY LED TO THE DISTAL FEMORAL AND PROXIMAL TIBIAL CUT BEING 5 DEGREES VALGUS. THERE WAS NO PATIENT CONSEQUENCE REPORTED AS A RESULT OF THE EVENT. 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

    AT THIS TIME THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION. 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 THE PATIENT COULD BE SUBJECT TO IF THE DEVICE PRODUCES INACCURATE MEASUREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POST-OP X-RAY SHOWS THAT BOTH DISTAL FEMORAL CUT AND PROXIMAL TIBIAL CUT WAS 5 DEGREES VALGUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15230 KNEEALIGN 2 REFERENCE SENSOR OLO ORTHALIGN, INC. 133632 00858704006015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention