BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN SYSTEM - COMPREHENSIVE

    MDR report key: 24589608 · Received March 13, 2026

    Report

    Report Number
    2953749-2026-00788
    Event Type
    Injury
    Date Received
    March 13, 2026
    Date of Event
    February 1, 2026
    Report Date
    March 13, 2026
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    UDI-DI
    00816063020189
    PMA / PMN Number
    K241412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CURRENT INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING: PRECAUTIONS - A TOOTH THAT HAS BEEN PREVIOUSLY TRAUMATIZED OR SIGNIFICANTLY RESTORED MAY BE AGGRAVATED. IN RARE INSTANCES, THE USEFUL 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.". NO ROOT CAUSE PROVIDED. ALIGN'S CLINICAL REVIEW FOUND THAT INITIAL SCAN PHOTOGRAPHS INDICATED TOOTH #30 HAD A PRE-EXISTING CROWN. ACCORDING TO THE PRESCRIPTION FORM FOR THE SECOND AND MOST RECENT ORDER, THE PATIENT COMPLETED ONLY SIX ALIGNERS FROM THE INITIAL TREATMENT SERIES, AND TOOTH #30 DID NOT UNDERGO SIGNIFICANT PLANNED MOVEMENT. THERE IS NO CONCLUSIVE EVIDENCE PROVIDED THAT SUPPORTS OR OPPOSES WHETHER THE INVISALIGN SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED DISABILITY OR PERMANENT DAMAGE. BASED ON THE AVAILABLE INFORMATION, THE PATIENT HAD DISABILITY OR PERMANENT DAMAGE, AND THE INVISALIGN SYSTEM WAS BEING USED. THEREFORE, AN MDR WILL BE FILED IN THE UNITED STATES PER 21 CFR 803. THERE IS NO CONCLUSIVE EVIDENCE TO CONFIRM THE DATE OF THE EVENT, AND THE DATE (B3) IS BASED ON THE TIMELINES REPORTED TO ALIGN AND COMPARED TO PATIENT INFORMATION.

    Description of Event or Problem · 0

    THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD THE SYMPTOM OF THE EXTRACTION OF TOOTH #30 (LR6). NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453983 INVISALIGN SYSTEM - COMPREHENSIVE ALIGNER, SEQUENTIAL NXC ALIGN TECHNOLOGY, INC. 9000 238780815 00816063020189

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Disability