BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHALIGN PLUS

    MDR report key: 9923332 · Received April 3, 2020

    Report

    Report Number
    3007521480-2020-00007
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Date of Event
    February 27, 2020
    Report Date
    August 5, 2021
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00851977007734
    PMA / PMN Number
    K172462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION OF RETURNED NAVIGATION UNIT LOG FILE FOUND A SIGNIFICANT CHANGE IN CUP VALUES WERE DISPLAYED AFTER THE CUP WAS IMPACTED. THE ROOT CAUSE OF THIS ISSUE IS NAVIGATING THE CUP WITH THE SENSOR ATTACHED TO THE IMPACTOR WHILE IMPACTING. ORTHALIGN DOES NOT RECOMMEND NAVIGATING DURING IMPACTION, IT CAN CAUSE DAMAGE AND LOSS OF NAVIGATION ACCURACY. ORTHALIGN RECOMMENDS NAVIGATING, TAKING THE SENSOR OFF THE IMPACTOR, THEN IMPACTING. AFTER IMPACTION, THE "CHECK CUP" FEATURE CAN BE UTILIZED TO VERIFY RESULTS. 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

    AN ORTHALIGN DISTRIBUTOR REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY THERE WAS A MALFUNCTION WITH THE NAVIGATION UNIT. WHILE PERFORMING THE CUP IMPLANTATION THE ACCURACY OF THE NAVIGATION UNIT WAS OFF BY GREATER THAN 3 DEGREES. ORTHALIGN PLUS UNITS HAVE BEEN CLEARED BY THE FDA WITH THE CLAIM OF +/- 3 DEGREES. AN INVESTIGATION WILL BE PREFORMED ONCE THE UNIT IS RETURNED FROM ORTHALIGN INC.'S DISTRIBUTOR IN (B)(6). WITH AN ABUNDANCE OF CAUTION THIS REPORT IS BEING FILED WITH THE UNDERSTANDING OF THE POTENTIAL PATIENT HARM THAT COULD RESULT FROM AN ACCURACY MALFUNCTION OF GREATER THAN 3 DEGREES. A FOLLOW UP REPORT WILL BE FILED WITH THE INVESTIGATION FINDINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TOTAL HIP ARTHROPLASTY WAS PERFORMED WITH HIPALIGN IN THE AFTERNOON WITH THE NAVIGATION UNIT AND REFERENCE SENSOR. WHILE THE SURGEON WAS IMPACTING CUP, ABDUCTION ANGLES WAS BIGGER AND BIGGER SUCH AS FROM 60 TO 70 DEGREES. HE IMPACTED THE CUP AGAIN, ANGLES THE NAVIGATION SHOWED WAS PROPER SUCH AS 40 DEGREE AND 15 DEGREE. ONLY THE ABDUCTION ANGLES BECAME BIGGER WHEN IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386768 ORTHALIGN PLUS NAVIGATION UNIT OLO ORTHALIGN, INC. 403001-05 00851977007734

    Patients

    Seq Age Sex Outcome Treatment
    1