BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 15462622 · Received September 22, 2022

    Report

    Report Number
    2953749-2022-02857
    Event Type
    Injury
    Date Received
    September 22, 2022
    Date of Event
    August 1, 2022
    Report Date
    September 9, 2022
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    UDI-DI
    00816063020189
    PMA / PMN Number
    K181739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CURRENT INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING: "WARNING - IN RARE INSTANCES, SOME PATIENT MAY BE ALLERGIC TO THE PLASTIC ALIGNER MATERIAL, DISCONTINUE USE AND CONSULT A HEALTH CARE PROFESSIONAL IMMEDIATELY," "PRECAUTIONS: IN RARE INSTANCES, PROBLEMS IN THE TEMPORO-MANDIBULAR JOINT (JAW JOINT) MAY RESULT IN JOINT PAIN, HEADACHES, OR EAR PROBLEMS," "EXISTING DENTAL RESTORATIONS (E.G: CROWNS, BRIDGES) MAY BECOME DISLODGED AND REQUIRE RE-CEMENTATION OR, IN SOME INSTANCES, REPLACEMENT," "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," "THE HEALTH OF THE BONE AND GUMS WHICH SUPPORT THE TEETH MAY BE IMPAIRED AND AGGRAVATED." THE POTENTIAL ROOT CAUSE IS UNKNOWN. THE DATE OF THE EVENT IS ONLY AN ESTIMATE BASED ON WHEN THE EVENT WAS RECEIVED BY ALIGN TECHNOLOGY, INC. THE TREATING DOCTOR'S OFFICE REPORTED THAT THIS PATIENT WAS REMOVED FROM THE PATIENT'S LIST OF THE OFFICE ALMOST 3 YEARS AGO AND HAS NOT BEEN TREATED BY THE OFFICE SINCE THEN. THE DR. MENTIONED THAT THE PATIENT FINISHED TREATMENT SUCCESSFULLY BY WEARING ALL ALIGNERS FROM THE ORIGINAL SET AND NEVER SHOWED UP TO THE OFFICE AGAIN SINCE 2019. 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 PRODUCT WAS BEING USED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED SYMPTOMS OF TMJ, DIFFICULTY BREATHING (HAD A DRY THROAT WHEN HE BREATHES, AND TONGUE WAS BLOCKING WINDPIPE MAKING BREATHING DIFFICULT) AND LOSS OF TEETH #41, #31, #11, AND #12. THE PATIENT DID NOT REPORT REQUIRING ANY MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT DID NOT REPORT BEING PRESCRIBED ANY MEDICATION BUT REPORTED TAKING A MUSCLE RELAXER (UNSPECIFIED) OVER THE COUNTER TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT IS CONTINUING THE USE OF THE ALIGNERS OR RETAINERS (THE TREATING DOCTOR LAST SAW THE PATIENT IN 2019 AFTER THE SUCCESSFUL COMPLETION OF TREATMENT WITH THE ORIGINAL SET OF ALIGNERS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2694284 INVISALIGN SYSTEM ALIGNER, SEQUENTIAL NXC ALIGN TECHNOLOGY, INC. INVISALIGN SYSTEM-COMPREHENSIVE 40964284 00816063020189

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Disability