BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMILEDIRECTCLUB LLC CLEAR ALIGNERS

    MDR report key: 16364473 · Received February 10, 2023

    Report

    Report Number
    MW5114889
    Event Type
    Injury
    Date Received
    February 10, 2023
    Date of Event
    February 4, 2023
    Report Date
    February 8, 2023
    Manufacturer
    SMILEDIRECTCLUB S.A.
    Product Code
    NXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I AM REPORTING SMILEDIRECTCLUB LLC AND THEIR DENTISTS FOR MEDICAL NEGLIGENCE AND IMPROPER ORTHODONTIC ASSESSMENT AND SERVICES. THEIR ORTHODONTIC SERVICES HAVE CAUSED SIGNIFICANT PROBLEMS WITH A PATIENT'S BITE, WHICH WERE NOT PRESENT PRIOR TO TREATMENT WITH THEM. THE PATIENT NOW NEEDS TO SEEK SERVICES FROM ANOTHER ORTHODONTIST TO FIX SUCH PROBLEMS OR ELSE LONG-TERM DAMAGE MAY OCCUR WITH THEIR JAW. FROM THE BEGINNING, THE PATIENT WAS NOT PROPERLY ASSESSED. NO DENTIST OR ORTHODONTIST SAW THE PATIENT IN-PERSON NOR WERE ANY X-RAYS TAKEN TO EVALUATE THE CONDITION OF THE PATIENT TEETH AND JAW STRUCTURE. ONLY A "3D SCAN" WAS DONE BY UNTRAINED STAFF AT ONE OF THE COMPANY'S SMALL OFFICES. THIS SCAN WAS THEN REVIEWED BY A TELEHEALTH DENTIST, DR. (B)(6) AND ONLY BASED ON THAT INFORMATION DID HE DETERMINE THAT THE PATIENT WAS A "GOOD CANDIDATE" FOR THE COMPANY'S ALIGNER TREATMENT. NO FOLLOWUPS WERE SCHEDULED. THE PATIENT HAD TO SEND IN PHOTOS OF THEIR TEETH MID-WAY THROUGH TREATMENT, WHICH DOES NOT ADEQUATELY ALLOW FOR ASSESSMENT OF SERIOUS PROBLEMS LIKE A SHIFT IN BITE. THE PATIENT HAD TO UNDERGO MULTIPLE "ALIGNER TOUCH-UPS", BASICALLY TO CONTINUE TO FIX THE PROBLEM THAT WAS CAUSED BY THE POOR TREATMENT PLAN. THE TREATMENT WHICH WAS SUPPOSED TO LAST 6 MONTHS, ENDED UP LASTING A WHOLE YEAR, WITH SIGNIFICANT CHANGES IN THE BITE THAT WAS NOT FIXED DESPITE CONSTANT REQUESTS BY THE PATIENT. THE PATIENT HAD TO ATTEMPT MULTIPLE TIMES TO CONTACT SDC FOR A REFUND BUT THEIR REQUESTS WERE IGNORED. ONLY AFTER SIGNIFICANT PERSISTENCE DID THE PATIENT ONLY GET AN OFFER FOR A PARTIAL REFUND BUT UNDER THE REQUIREMENT THAT THEY SIGN AN NDA. THIS NDA PROHIBITS THE PATIENT FROM NOT ONLY LEGAL RECOURSE BUT ALSO FROM SHARING ANY NEGATIVE EXPERIENCES TO ANYONE, INCLUDING SOCIAL MEDIA, OR ANY GOVERNMENTAL REPORTING AGENCIES ABOUT THE COMPANY'S SERVICES. THIS TYPE OF BEHAVIOR IS ANTI-CONSUMER AND IMPEDES ON THE RIGHTS OF A CONSUMER TO WARN OTHERS OF THE DANGERS OF A COMPANY'S PRACTICES. MULTIPLE MEDIA OUTLETS HAVE REPORTED ON THIS COMPANY'S DANGEROUS PRACTICES AND I THINK ACTION SHOULD BE TAKEN AGAINST THIS COMPANY'S MALPRACTICE. PATIENT DID NOT HAVE ANY PRE-EXISTING PROBLEMS WITH THEIR JAW OR BITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2235645 SMILEDIRECTCLUB LLC CLEAR ALIGNERS ALIGNER, SEQUENTIAL NXC SMILEDIRECTCLUB S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Required Intervention| O