BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHALIGN PLUS

    MDR report key: 8512163 · Received April 13, 2019

    Report

    Report Number
    3007521480-2019-00009
    Event Type
    Malfunction
    Date Received
    April 13, 2019
    Date of Event
    March 8, 2019
    Report Date
    March 23, 2020
    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

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION BY ORTHALIGN AND THUS THE INITIAL REPORT CANNOT BE CONFIRMED. THE PRODUCT'S SERIAL NUMBER WAS GIVEN TO ORTHALIGN AND DEVICE HISTORY RECORD REVIEW WAS PERFORMED. THIS DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. WITHOUT PRODUCT A FAILURE ANALYSIS COULD NOT BE PERFORMED. NO FURTHER INFORMATION WAS MADE AVAILABLE TO ORTHALIGN AND THE INVESTIGATION HAS BEEN CLOSED. IF THE PRODUCT IS EVER RETURNED TO ORTHALIGN A SUBSEQUENT REPORT WILL BE FILED.

    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 7 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)(4). 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 7 DEGREES. A FOLLOW UP REPORT WILL BE FILED WITH THE INVESTIGATION FINDINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NAVIGATION UNIT PREPARED FOR TOTAL HIP ARTHROPLASTY WAS PERFORMED WITH ORHALIGN PLUS NAVIGATION. AFTER CUP INSTALLATION, THE UNIT DISPLAY SUDDENLY BECAME BLACK AND THE DISPLAY WENT BACK TO OPENING SCREEN. ALSO, AFTER PRELIMINARY CUP FIXATION, THE SURGEON FOUND ACTUAL ANGLE SHOWED IN X-RAY WAS DIFFERENT FROM THE ANGLE THE NAVIGATION SHOWED. (7 DEGREES) PRELIMINARY CUP FIXATION: ABDUCTION 40 DEGREE. X-RAY PHOTO: ABDUCTION 33 DEGREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305423 ORTHALIGN PLUS NAVIGATION UNIT OLO ORTHALIGN INC. 403001-04 NA 00851977007734

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention