BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOFX ALIGNER

    MDR report key: 17408624 · Received July 27, 2023

    Report

    Report Number
    3015143007-2023-00001
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    March 21, 2023
    Report Date
    May 23, 2023
    Manufacturer
    ORTHOFX
    Product Code
    NXC
    UDI-DI
    00860003321706
    PMA / PMN Number
    K173784
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT REPORTED INFECTION DUE TO DISCOMFORT WITH ALIGNER EDGES. PATIENT HAD DISCARDED ALIGNER PRIOR TO CONTACTING ORTHOFX. ORTHOFX REVIEWED MANUFACTURING RECORDS AND TREND ANALYSIS REGARDING THIS EVENT; NO ISSUES WERE FOUND. ALIGNERS WERE REPLACED FOR GOOD CUSTOMER SUPPORT. PATIENT WAS PROACTIVELY CONTACTED BY CUSTOMER SERVICE TO ASSESS AND HELP RESOLVE ALL COMPLAINT ISSUES.

    Description of Event or Problem · 0

    THE PATIENT REPORTED HAVING A PREVIOUS SET OF ALIGNERS WITH SHARP EDGES THAT CAUSED AN INFECTION AND RECEIVED ANTIBIOTICS DUE TO THE INFECTION. A MANAGER WITHIN THE SMYLIO CUSTOMER SUCCESS TEAM MANAGER, "M", CONTACTED THE PATIENT ON (B)(6), 2023 TO REQUEST ADDITIONAL INFORMATION REGARDING THE INFECTION THEY EXPERIENCED AND WHETHER OR NOT THEY RECEIVED MEDICAL INTERVENTION. ON (B)(6), 2023, CUSTOMER SUCCESS TEAM MEMBER K POSTED ON THE SALESFORCE COMPLAINT RECORD THAT PATIENT A COMMUNICATED THAT THEIR MEDICAL DOCTOR PRESCRIBED AMOXICILLIN 875 MG ON (B)(6), 2023 FOR THE REPORTED INFECTION. THUS, ON (B)(6), THIS COMPLAINT WAS DEEMED REPORTABLE BECAUSE THE PATIENT NOTIFIED THE CS TEAM THAT SHE RECEIVED MEDICAL INTERVENTION. FOLLOWING THE REPORT OF THE INFECTION, THE CUSTOMER SUCCESS TEAM CONTINUED TO STAY IN CONTACT WITH THE PATIENT. THE PATIENT WAS NO LONGER EXPERIENCING ISSUES WITH THE INFECTION. THE PATIENT CONTACTED THE CS TEAM ON (B)(6), STATING THAT THEY RECEIVED THEIR REPLACEMENT ALIGNERS AT THEIR DOCTOR'S OFFICE AND THE DOCTOR ASSISTED WITH MAKING A FEW MODIFICATIONS, SUCH AS FILING THE ALIGNERS DOWN. THE PATIENT CONFIRMED THAT THE NEW ALIGNERS WERE NOT CAUSING ANY ADDITIONAL ISSUES. ON (B)(6), THE PATIENT NOTIFIED THE CS TEAM THAT THE NEW ALIGNERS WERE NOT PRESENTING ANY ISSUES. ON (B)(6), THE PATIENT REACHED OUT TO THE CS TEAM TO NOTIFY THEM THAT THEY WERE PROCEEDING WITH TREATMENT AND NOT EXPERIENCING ANY ISSUES. ON JUNE 15TH THE PATIENT REACHED OUT TO THE CS TEAM FOR INFORMATION REGARDING THEIR ACCOUNT AND PLAN INFORMATION SO THE PATIENT COULD PAY FOR THEIR TREATMENT IN FULL. THE PATIENT CONFIRMED THAT THEY ARE NOT EXPERIENCING ANY ADDITIONAL ISSUES AND WANT TO CONTINUE WITH THE ORTHOFX ORTHODONTIC TREATMENT. THE CS TEAM PERFORMED ONE FINAL FOLLOW UP ON (B)(6), 2023, WHERE THE PATIENT NOTIFIED THE CS TEAM THAT THEY ARE HAPPY WITH THEIR PRODUCT. AS ON (B)(6), 2023, THE PATIENT COMPLAINT CASE HAS BEEN RESOLVED WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827000 ORTHOFX ALIGNER DENTAL ALIGNER NXC ORTHOFX SMYLIO CLEAR ALIGNER 2205-226 00860003321706

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention