BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN

    MDR report key: 4190221 · Received October 15, 2014

    Report

    Report Number
    MW5038683
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    July 16, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ALIGN
    Product Code
    NXC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED ON (B)(6) 2014. A DENTIST IN (B)(6) (OUTSIDE OF THE LOCAL DENTAL NETWORKING) HAS SENT ME THE EARLY RESULTS OF A THOROUGH EXAMINATION (INCLUDING CASTS AND PHOTOGRAPHS AND MEASUREMENTS AND EXAMINATION AND FOUND I HAVE A "DESTRUCTIVE BITE," AND HE IS GOING TO FURTHER EVALUATE THE MODELS AND PERHAPS CONSULT WITH AN ORTHODONTIST IN ORDER TO DETERMINE AND HE IS MEASURES TO BRING BACK A PROPER DENTAL OCCLUSION. I HAVE LEFT A MESSAGE FOR HIM TO CALL, TO FIND OUT WHAT SPECIFIC FURTHER RECOMMENDATIONS HE IS READY TO MAKE. HERE IS HIS REPORT: PT REPORT FOR (B)(6) I THOUGH YOU WOULD APPRECIATE A SUMMARY OF THE FINDINGS AND RECOMMENDATIONS FOR TREATMENT. PLEASE NOTE SOME OR ALL OF THE RECOMMENDED TREATMENT MAY BE COMPLETE PRIOR TO YOUR RECEIPT OF THIS REPORT. DURING OUR INITIAL INTERVIEW YOU EXPRESSED CONCERN REGARDING BITE CHANGES AFTER INVISALIGN TREATMENT. HERE IS A SUMMARY OF MY EXAMINATION FINDINGS: GUMS. GUM INFECTION. RECESSION PRESENT. CALCULUS. JAW BONE, WITHIN NORMAL LIMITS. XRAYS. NO PATHOLOGY DETECTED. BITE ANALYSIS. YOUR BITE IS DESTRUCTIVE. JAW, JOINT, STABLE. MUSCLE TENDERNESS DETECTED. HEAD AND NECK. NO ORAL. CANCER WAS DETECTED. NORMAL AIRWAY. TEETH, NO DECAY. CRACKS. WEAR. ABFRACTION. LARGE FILLINGS. MOBILITY. THE GOAL OF MY PRACTICE IS TO HELP YOU KEEP YOUR NATURAL TEETH FOR LIFE WITH MAXIMUM COMFORT, FUNCTION AND AESTHETICS. AFTER REVIEWING YOUR X-RAYS AND PERFORMING YOUR EXAMINATION, I FEEL CONFIDENT IN RECOMMENDING THE FOLLOWING APPROACH FOR YOUR DENTAL HEALTH. THE OBJECTIVE OF YOUR TREATMENT IS TO IMPROVE YOUR ORAL HEALTH. YOUR TREATMENT WILL FOLLOW THIS GENERAL SEQUENCE: EVAL OF YOUR TOOTH MODELS. POSSIBLE CONSULTATION WITH THE ORTHODONTIST.

    Description of Event or Problem · 1

    I SENT THIS NOTICE DESCRIBING THE HARM OF THEIR DEVICE AND ORTHODONTIC DIGITAL MEASUREMENT TO ALIGN INC, MFR OF INVISALIGN, YESTERDAY, TUESDAY (B)(6) 2014. MY PURPOSE IN OBTAINING ORTHODONTURE WAS TO PROTECT MY CENTRAL INCISORS FROM FURTHER EROSION OF TOOTH ENAMEL CAUSED BY MALALIGNMENT. I AUTHORIZE YOU TO OBTAIN ALL PERTINENT DENTAL RECORDS. I HAD A PERFECT OCCLUSION BEFORE THIS WAS DONE. DEAR INVISALIGN, I AM REPORTING TO YOUR CO THAT A COURSE OF INVISALIGN TREATMENT HAS DESTROYED MY PERFECT DENTAL OCCLUSION, AS EVIDENCED BY DENTAL RECORDS, AND REPLACED IT WITH A GROSS POSTERIOR OPEN BITE IN WHICH ONLY THE FOUR CENTRAL INCISORS MEET. THIS MEANS THERE IS NO BITING SURFACE OF THE REMAINING TEETH WITHOUT MALPOSITIONING THE JAWS AND PUTTING A STRAIN ON THE TMJ, VIEWING THE DIGITIZED INVISALIGN ANIMATION, THE PROBLEM COULD HAVE BEEN ANTICIPATED BY BOTH INVISALIGN AND BY THE ORTHODONTIST. IT APPEARS THAT THE MANDIBULAR DENTAL ARCH WAS NEEDLESSLY FORESHORTENED AND THAT NO THOUGHT WAS GIVEN TO THE PROPER POSITIONING OF THE MANDIBULAR TEETH RELATIVE TO THE MAXILLARY TEETH. THE CREATION OF A GROSS POSTERIOR OPEN BITE CALLS INTO SERIOUS QUESTION THE ADEQUACY OF THE INVISALIGN METHOD, AND THE DIGITALIZATION OF ORTHODONTIC MEASUREMENTS ON WHICH THE INVISALIGN METHOD IS BASED, AS WELL AS THE DESIGN OF INVISALIGN BRACES BASED UPON SUCH MEASUREMENTS AND DIGITAL PROJECTIONS OF TREATMENT RESULTS. THE DESTRUCTION OF A PT'S OCCLUSION IS A SERIOUS MATTER AND CANNOT BE TRIVIALIZED AS A MATTER OF "CUSTOMER INCONVENIENCE." I LOOK FORWARD TO YOUR RESPONSE AS TO WHAT REMEDIES YOUR CO MAY PROPOSE. THE COST OF THIS INVISALIGN TREATMENT EXCEEDS (B)(6) PLUS HAVING TO RESORT TO PAYING FOR A BITE LANE TO PROTECT THE ENAMEL OF MY TEETH. I LOOK FORWARD TO RECEIVING YOUR REPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652668 INVISALIGN INVISALIGN NXC ALIGN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention| S ASPIRIN