{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-18", "results": { "skip": 0, "limit": 1, "total": 18498 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "NO INFORMATION", "report_to_fda": "I", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "MW5094274", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200225", "reprocessed_and_reused_flag": "I", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PATIENT", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "467193", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "SMILEDIRECTCLUB CLEAR ALIGNERS", "generic_name": "ALIGNER, SEQUENTIAL", "manufacturer_d_name": "SMILEDIRECTCLUB / ALIGN TECHNOLOGY, INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "I", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "NXC", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Aligner, Sequential", "medical_specialty_description": "Dental", "regulation_number": "872.5470", "device_class": "2" } } ], "product_problems": [ "Inadequacy of Device Shape and/or Size" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250811", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "25 YR", "patient_sex": "", "patient_weight": "72", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Sensitivity of Teeth", "Sensitivity of Teeth" ] } ], "distributor_city": "", "date_report": "20200423", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10004598", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Voluntary report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189452376", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "I ORIGINALLY STARTED MY SMILEDIRECTCLUB TREATMENT ON (B)(6) 2019. I REACHED OUT ABOUT AN ISSUE WITH THE FIT OF MY ALIGNERS ON (B)(6) 2019 FOR ISSUES WITH THE FIT OF MY ALIGNERS. I WAS APPROVED FOR A NEW COURSE OF TREATMENT ON (B)(6) 2019. I STARTED TREATMENT AGAIN ON (B)(6) 2019. I BELIEVE MY CASE NUMBER FOR THIS COURSE IS (B)(4). THESE NEW ALIGNERS HAVE CAUSED PERMANENT DAMAGE TO MY OTHERWISE HEALTHY GUMS. I NOTICED GUM RECESSION ROUGHLY A MONTH INTO MY NEW COURSE OF TREATMENT. I BRUSH, FLOSS, AND USE MOUTHWASH EVERY TIME I EAT OR DRINK SO MY GUM HEALTH WAS NEVER A PROBLEM. MY GUMS ARE DIFFERENT IN MY MOUTH THAN THEY APPEAR TO BE ON MY POOR-FITTING ALIGNERS, WHICH PUT UNNECESSARY PRESSURE ON THEM. ONE OF MY ALIGNERS WOULD CONSISTENTLY CUT INTO MY GUMLINE SO BAD THAT IT WOULD BLEED. IT WASN'T AN ISSUE WITH SHARP EDGES (SO IT COULDN'T BE \"HACKED\" WITH ORTHODONTIC WAX OR FILING, AS THEY RECOMMEND), BUT THE FIT OF THAT SPECIFIC ALIGNER WHERE MY FRONT TOOTH MEETS MY GUMLINE, CUTTING DEEP ENOUGH INTO MY GUMS TO DRAW BLOOD. OVER A 5 WEEK PERIOD, THESE POOR FITTING ALIGNERS CAUSED MY GUMS TO RECEDE. THEY ALSO CAME OUT OF ORDER. THE MONTH 2, WEEK 2 ALIGNER IS WHAT MY TEETH ARE SUPPOSED TO LOOK LIKE AT THE END OF THE TREATMENT--PERFECTLY STRAIGHT, THE LAST IMAGE ON MY 3D SCAN. I SHOULDN'T HAVE TO PAY CLOSE TO (B)(6) TO DO THE GUESSWORK ON FINDING OUT WHICH ALIGNER TO WEAR NEXT. I HAVE ALREADY BEEN GIVEN A BAD PRODUCT AND HAVE NO WAY OUT SINCE I HAVE TO OPEN NEXT WEEK'S ALIGNERS (OR THE NEXT, OR THE NEXT) TO FIGURE OUT HOW TO CONTINUE TREATMENT MYSELF. IT'S DANGEROUS FOR A PATIENT TO HAVE TO DO THE GUESSWORK ON THEIR OWN TREATMENT. I FIRST CONTACTED SMILEDIRECTCLUB ABOUT MY ISSUE WITH THIS SET OF ALIGNERS IN (B)(6) AND DID NOT HEAR BACK UNTIL I FILED A COMPLAINT WITH (B)(6). AFTER FILING A COMPLAINT WITH THE (B)(6), I WAS CONTACTED BY AN ACCOUNT MANAGER ON (B)(6). I AGREED TO A PARTIAL REFUND UPON RETURN OF THE FAULTY PRODUCT ON (B)(6) AND WAS TOLD I WOULD RECEIVE A GENERAL RELEASE FORM IN 3-7 DAYS. IT HAS BEEN 16 DAYS AND I'VE REACHED OUT AGAIN TO NO RESPONSE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }