BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVERA RETAINERS

    MDR report key: 19700794 · Received July 9, 2024

    Report

    Report Number
    2953749-2024-01724
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    March 12, 2024
    Report Date
    July 9, 2024
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    DYT
    UDI-DI
    00816063020028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOGRAPHS PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THE PART AND LOT NUMBERS, AND NO DISCREPANCIES WERE FOUND. PRODUCTS WERE MANUFACTURED ACCORDING TO INTERNAL AND EXTERNAL REQUIREMENTS. THE CURRENT INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING: "GENERAL RISKS TO PATIENTS - GUMS, CHEEKS, OR LIPS MAY BE SCRATCHED OR IRRITATED BY THE RETAINER". NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THAT THE VIVERA RETAINERS CAUSED OR CONTRIBUTED TO THE REPORTED SYMPTOM OF SEVERE DYSPLASIA. THIS EVENT IS BEING FILED AS AN MDR PER 21 CFR 803 AS THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD THE SYMPTOM OF SEVERE DYSPLASIA ON TONGUE WHICH REQUIRED SURGERY TO REMOVE AND THE VIVERA RETAINERS WERE BEING USED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ALIGN TECHNOLOGY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF DISCOMFORT AND A LESION ON THE TONGUE (WHITE SPOT) WHICH GREW LARGER OVER 5 MONTH TIMEFRAME. THE TREATING DOCTOR REPORTED THAT THE PATIENT REQUIRED VISITING THE DENTAL CLINIC TO ALLEVIATE THE REPORTED SYMPTOMS, AND THE PATIENT WAS REFERRED TO STOMATOLOGY FOR BIOPSY AND SURGERY. THE PATIENT REPORTED DISCONTINUING THE USE OF THE VIVERA RETAINERS AND IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250003 VIVERA RETAINERS MAINTAINER, SPACE PREFORMED, ORTHODONTIC DYT ALIGN TECHNOLOGY, INC. VIVERA RETAINERS 158208220 00816063020028

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention| O