BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFERENCE SENSOR 4

    MDR report key: 12294357 · Received August 9, 2021

    Report

    Report Number
    3007521480-2021-00022
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    February 19, 2020
    Report Date
    August 5, 2021
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00858704006589
    PMA / PMN Number
    K130387
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE RETURNED REFERENCE SENSOR S/N (B)(4) DID NOT FIND ANY ISSUES DURING SIMULATED PROCEDURES. ADDITIONALLY, NO NAVIGATION UNIT WAS RETURNED SO THE COMPLAINT COULD NOT BE CONFIRMED. FROM THE COMPLAINT DESCRIPTION, THE REASON FOR THE ISSUE SEEN BY THE USER IS THE SENSOR WAS ON THE IMPACTOR DURING IMPACTION. ORTHALIGN RECOMMENDS REMOVING THE SENSOR FROM THE IMPACTOR PRIOR TO IMPACT. IT HAS BEEN FOUND THAT IMPACTING WITH THE SENSOR ATTACHED CAN CAUSE DAMAGE TO THE SENSOR OR RESULT IN ACCURACY ISSUES. 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

    IT WAS REPORTED THAT TOTAL HIP ARTHROPLASTY WAS PERFORMED WITH HIPALIGN. DURING CUP IMPACTION, CR2 BATTERY WAS DEPLETED SO ANOTHER CR2 BATTERY WAS USED. THE SURGEON TRIED TO IMPACT CUP AGAIN AFTER HE ADJUSTED ANTEVERSION ANGLE BUT ANGLES NAVIGATION UNIT SHOWED WAS UNUSUAL THAT ABDUCTION ANGLE WAS OVER 50 DEGREE. SUBSEQUENTLY, HE IMPACTED THE CUP WITH ROUGH INDICATION. BALL JOINT OF THE PELVIC BASE CREST WAS FIRMLY FIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191333 REFERENCE SENSOR 4 REFERENCE SENSOR OLO ORTHALIGN, INC. 403087-06 00858704006589

    Patients

    Seq Age Sex Outcome Treatment
    1