BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOFX NITIME ALIGNERS

    MDR report key: 21143243 · Received January 13, 2025

    Report

    Report Number
    3015143007-2025-00001
    Event Type
    Injury
    Date Received
    January 13, 2025
    Date of Event
    December 12, 2024
    Report Date
    January 9, 2025
    Manufacturer
    ORTHOFX
    Product Code
    NXC
    UDI-DI
    00860003321782
    PMA / PMN Number
    K221537
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INTERNAL DOCUMENTATION SHOWS THERE WAS NOT AN ISSUE WITH THE DEVICE AND AS REPORTED THE DENTIST AND PATIENT ORDERED 2ND DEVICE. IN ADDITION, NEITHER THE PATIENT NOR THE TREATING DENTIST HAVE BEEN RESPONSIVE TO A MONTH OF REPEATED CONTACT ATTEMPTS BY MULTIPLE PARTIES. THIS INDICATES THE DEVICE WAS NOT LIKELY THE CAUSATIVE ITEM FOR THE SUSPECTED REPORTED INJURY.

    Description of Event or Problem · 0

    A PRODUCT REVIEW WAS POSTED ON YOTPO AS FOLLOWS: "PRODUCT REVIEW DISAPPOINTED. THE ORTHOFX EXPERIENCE HAS NOT BEEN GREAT. BEFORE STARTING ORTHOFX, I HAD TROUBLE FINDING DATA AROUND WHAT THE TOOTH FRACTURE RATES WERE FOR PATIENTS. MY DENTIST ASSURED ME THAT IN HIS EXPERIENCE HE DID NOT SEE THIS MUCH. SINCE FIRST 20 WEEK SET OF TRAYS I HAD ONE TOOTH PULLED AND I HAD ANOTHER TOOTH THAT REQUIRED A CROWN WHEN IT SHEARED AFTER A VISIT WITH THE DENTIST AT THE HALFWAY POINT. AFTER 20 WEEKS MY BOTTOM TEETH ARE CROOKED AND DO NOT LOOK AT ALL LIKE THE SIMULATIONS. A NEW SET OF TRAYS WERE ORDERED BEFORE THE HOLIDAYS AND THEY HAVE STILL NOT COME IN. IN ADDITION, AFTER WEEK 20, MY DENTIST AND I HAD A REAL HEART TO HEART CONVERSATION ABOUT MY DISAPPOINTMENT. DURING THAT VISIT I LEARNED THAT ORTHOFX SHOULD HAVE STARTED SOME SORT OF MONITORING BY ME TAKING PICTURES WITH MY CELL PHONE ON A PERIODIC BASIS. I WAS NEVER PROMPTED TO DO THIS. SEEMS TO ME ORTHOFX IS MORE CONCERNED ABOUT UPFRONT PAYMENTS THEN ADDRESSING CONCERN OF END USER- PATIENTS LIKE ME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486302 ORTHOFX NITIME ALIGNERS CLEAR ALIGNERS NXC ORTHOFX 013 00860003321782

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention