{ "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": 60 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3007130440-2020-00001", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200826", "manufacturer_address_2": "", "pma_pmn_number": "K113618", "date_of_event": "20200701", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "DENTIST", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200826", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "917445", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200826", "brand_name": "CLEARCORRECT SYSTEM / ALIGNERS", "generic_name": "CLEAR PLASTIC ORTHODONTIC ALIGNER", "manufacturer_d_name": "CLEARCORRECT LLC", "manufacturer_d_address_1": "21 CYPRESS BLVD", "manufacturer_d_address_2": "", "manufacturer_d_city": "ROUND ROCK, TX", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210807", "model_number": "Aligner (Single-Layer)", "catalog_number": "REF-01", "lot_number": "234825", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NXC", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "D865REF00011", "udi_public": "+D865REF00011/$$523033234825/16D20200202", "openfda": { "registration_number": [ "3007130440" ], "fei_number": [ "3007130440" ], "device_name": "Aligner, Sequential", "medical_specialty_description": "Dental", "regulation_number": "872.5470", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250729", "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": "20200826", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "78 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Tooth Fracture", "Tooth Fracture" ] } ], "distributor_city": "", "date_report": "20200814", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10457238", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200717", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Inspection" ], "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": "204538166", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "A REVIEW OF THE CASE SHOWS THE PROVIDER WAS HAVING DIFFICULTY WITH THE TEETH TRACKING AS THEY SHOULD. REPLACEMENTS WERE REQUESTED FOR PHASE 1 STEPS 1-2 UPPER ON (B)(6) 2020. REPLACEMENTS WERE REQUESTED FOR PHASE 1 STEPS 1-2 UPPER AND LOWER ON (B)(6) 2020. REPLACEMENTS WERE REQUESTED FOR PHASE 1 STEPS 1-5 UPPER ON (B)(6) 2020. A REVIEW OF THE PATIENT SUBMISSION AT THE BEGINNING OF TREATMENT SHOWS STRESS FRACTURES TO TOOTH 24 AND POOR HYGIENE WHICH CAN CONTRIBUTE TO THE BROKEN TOOTH. CLINICAL EVALUATION: STARTING TREATMENT PHOTOS SHOW THAT THE ARCH WAS ALREADY IN A STATE OF DECLINE. FAILING RESTORATION ON THE TOOTH CAUSED THE BROWNING IN THE LOCATION OF DAMAGE. BROWNING COULD BE DUE TO YEARS OF FAILED RESTORATION SEEPAGE. DAMAGE OF THE TEETH MAY BE MORE RELATED TO THE DECLINE OF THE DENTITION. OTHER THAN THAT ASSESSMENT, THERE DOES NOT APPEAR TO BE A MEDICAL RISK ASSOCIATED WITH THE COMPLAINT. A REQUEST FOR RETURN OF THE PRODUCT WAS SUBMITTED TO THE PROVIDER BUT PRODUCT HAS NOT YET BEEN RECEIVED." }, { "mdr_text_key": "204538167", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE DOCTOR CALLED AND SAID SHE HAD A LOT OF TROUBLE WITH THE CASE. THE TEETH ARE NOT TRACKING AS HOPED. SHE RESORTED TO USING 2 UPPER TRAYS PER STEP. ON (B)(6), SHE INSERTED TRAY 4 AND THEN THAT NIGHT THE PATIENT TOOK THE TRAY OUT AND THE TOOTH BROKE. ON (B)(6) 2020, A REVISION WAS SUBMITTED. THE RX NOTES SHOW: \"TOOTH #24 BROKE FROM THE FORCE OF THE TRAY DURING REMOVAL OF TRAY #4. UPPER TRAY #4 IS NOT WELL SEATED IN ANTERIOR AREA. THERE IS A GAP BETWEEN THE TRAY AND HIS INCISAL EDGES. I HAVE CALLED REPEATEDLY FOR HELP ON THIS CASE AND TRIED THE SUGGESTIONS AND NOTHING IS WORKING. I OPTED TO TAKE NEW IMPRESSIONS TO START OVER. PLEASE SLOW DOWN THE MOVEMENT (MORE TRAYS WITH LESS MOVEMENT BETWEEN STEPS). HE IS AN OLDER PATIENT AND MAXILLARY TEETH ARE NOT MOVING WELL.\"" } ], "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": "" } ] }