BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHALIGN PLUS

    MDR report key: 8759815 · Received July 3, 2019

    Report

    Report Number
    3007521480-2019-00013
    Event Type
    Malfunction
    Date Received
    July 3, 2019
    Date of Event
    May 27, 2019
    Report Date
    July 30, 2021
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00858704006589
    PMA / PMN Number
    K172462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO FAULT COULD BE FOUND WITH THE RETURNED REFERENCE SENSOR, RS S/N: (B)(6). THE REFERENCE SENSOR PASSED ALL VISUAL AND FUNCTIONAL TESTS. 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 REFERENCE SENSOR. AN INVESTIGATION WILL BE PREFORMED ONCE THE REFERENCE SENSOR 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. 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. SURGEON INSTALLED A CUP TO THE PATIENT HIP WITH IMPACTOR CONNECTED TO THE REFERENCE SENSOR. HOWEVER, ANGLE OF THE CUP WAS SHOWN ABNORMALLY AFTER THE CUP INSTALLATION. SUBSEQUENTLY, CONVENTIONAL METHOD WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553496 ORTHALIGN PLUS REFERENCE SENSOR OLO ORTHALIGN, INC. 403087 NA 00858704006589

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention