BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 16907877 · Received May 10, 2023

    Report

    Report Number
    2953749-2023-01527
    Event Type
    Injury
    Date Received
    May 10, 2023
    Date of Event
    June 1, 2021
    Report Date
    April 9, 2023
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    UDI-DI
    00816063020189
    PMA / PMN Number
    K220287
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT TOOK PLACE ABOUT 2 YEARS AGO AND THIS REPORT IS BASED ON THE LIMITED INFORMATION PROVIDED BY THE PATIENT SINCE THE PATIENT DID NOT WANT ALIGN TECHNOLOGY, INC. TO REACH OUT TO THE TREATING DOCTOR. 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"; AND "THE HEALTH OF THE BONE AND GUMS WHICH SUPPORT THE TEETH MAY BE IMPAIRED OR AGGRAVATED"; AND "THE LENGTH OF THE ROOTS OF THE TEETH MAY BE SHORTENED DURING ORTHODONTIC TREATMENT, WHICH MAY BECOME A THREAT TO THE LONGEVITY OF THE TEETH". THE POTENTIAL ROOT CAUSE IS UNKNOWN. NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THE FACT THAT THE INVISALIGN SYSTEM ALIGNERS CAUSED THE REPORTED SYMPTOM. THIS EVENT IS BEING FILED AS AN MDR AS THE PATIENT REPORTED TOOTH LOSS (SERIOUS INJURY) AND THE INVISALIGN SYSTEM ALIGNERS WERE BEING USED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THE ALIGNERS WERE TIGHT AND CAUSED HER TOOTH TO ROTATE INTO GUMS, CAUSED PAIN, BLEEDING AND ULTIMATELY LED TO THE EXTRACTION OF THE TOOTH. THE PATIENT REPORTED REQUIRING VISITING A DOCTOR TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT IS CONTINUING THE USE OF THE ALIGNERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231574 INVISALIGN SYSTEM ALIGNER, SEQUENTIAL NXC ALIGN TECHNOLOGY, INC. INVISALIGN SYSTEM - COMPREHENSIVE 90212158 00816063020189

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Disability