BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 18566669 · Received January 23, 2024

    Report

    Report Number
    2953749-2024-00112
    Event Type
    Injury
    Date Received
    January 23, 2024
    Date of Event
    January 1, 2024
    Report Date
    January 23, 2024
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    UDI-DI
    00816063020004
    PMA / PMN Number
    K220287
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CURRENT INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING: "PRECAUTIONS - THE ROOT LENGTHS OF THE TEETH MAY BE SHORTENED (ROOT RESORPTION) DURING ORTHODONTIC TREATMENT CAUSING A THREAT TO LONGEVITY OF THE TEETH." AND "A TOOTH THAT HAS BEEN PREVIOUSLY TRAUMATIZED OR SIGNIFICANTLY RESTORED MAY BE AGGRAVATED. IN RARE INSTANCES, THE LIFE OF THE TOOTH MAY BE REDUCED, THE TOOTH MAY REQUIRE ADDITIONAL DENTAL TREATMENT SUCH AS ENDODONTIC AND/OR ADDITIONAL RESTORATIVE WORK, AND/OR THE TOOTH MAY BE LOST" AND "ORTHODONTIC TREATMENT (INCLUDING ALIGNER TREATMENT) MAY IMPAIR THE HEALTH OF THE BONE AND GUMS WHICH SUPPORT THE TEETH AND MAY AGGRAVATE THE GUMS". THE TREATING DOCTOR SHARED THAT THEY DO NOT KNOW THE POTENTIAL ROOT CAUSE OF THE TOOTH EXTRACTIONS AS THE EXTRACTIONS WERE PERFORMED BY THE PATIENT'S DENTIST. THE PATIENT REPORTED THE FOLLOWING: PATIENT'S DENTIST (NOT TREATING DOCTOR) INDICATED THAT THE REPORTED SYMPTOM OF BONE LOSS WAS DUE TO THE TREATMENT MOVEMENT BEING TOO FAST (AS REPORTED BY THE PATIENT). AFTER ALIGN'S CLINICAL ANALYSIS, THERE IS NO EVIDENCE OF A PRE-EXISTING CONDITION ON THE REPORTED AFFECTED TEETH (#25 AND #26), AND BUCCAL MOVEMENT WAS PROGRAMMED ON LOWER ANTERIOR TO ALIGN TOOTH #24. THIS EVENT IS BEING FILED AS AN MDR AS THE PATIENT REPORTED TOOTH LOSS (SERIOUS INJURY) AND AN INVISALIGN PRODUCT WAS BEING USED.

    Description of Event or Problem · 0

    THE PATIENT DIRECTLY REPORTED THE FOLLOWING: THE PATIENT REPORTED SYMPTOMS OF BONE LOSS, TOOTH EXTRACTION (TOOTH #25 AND #26) AND IMPLANTS REQUIRED (TOOTH #25 AND #26). IT IS UNKNOWN IF MEDICAL INTERVENTION WAS REQUIRED TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT REQUIRED ANY PRESCRIPTION MEDICATIONS TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT REPORTED FINISHING THE INVISALIGN TREATMENT IN (B)(6) 2021, AND IS CURRENTLY WEARING RETAINERS (NOT AN ALIGN TECHNOLOGY INC. PRODUCT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838709 INVISALIGN SYSTEM ALIGNER, SEQUENTIAL NXC ALIGN TECHNOLOGY, INC. INVISALIGN FULL 59586021 00816063020004

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Disability