{ "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": 3 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "JOHAR TOWN", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MRS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "LAHORE, PUNJAB", "manufacturer_contact_address_1": "1822 ASTON AVE", "manufacturer_contact_pcity": "76044886", "event_type": "Injury", "report_number": "2081322-2021-00001", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20211117", "manufacturer_address_2": "", "pma_pmn_number": "K162609", "date_of_event": "20211021", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92008", "reporter_occupation_code": "DENTIST", "manufacturer_contact_plocal": "7604488600", "noe_summarized": "1", "manufacturer_contact_l_name": "GARMAN", "source_type": [ "Consumer", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "54000", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "760", "date_added": "20211118", "manufacturer_contact_f_name": "WENDY", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1724006", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20211117", "brand_name": "REVEAL CLEAR ALIGNERS", "generic_name": "ALIGNER, SEQUENTIAL", "manufacturer_d_name": "ORTHO ORGANIZERS, INC.", "manufacturer_d_address_1": "1822 ASTON AVE", "manufacturer_d_address_2": "", "manufacturer_d_city": "CARLSBAD", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92008", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "92008", "device_operator": "OTHER", "model_number": "570-1422", "catalog_number": "570-1422", "lot_number": "HD11745", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NXC", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00190707089788", "udi_public": "00190707089788", "openfda": { "device_name": "Aligner, Sequential", "medical_specialty_description": "Dental", "regulation_number": "872.5470", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "NV", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250803", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7604", "patient": [ { "patient_sequence_number": "1", "date_received": "20211117", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Disability" ], "patient_age": "70 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Tooth Fracture", "Tooth Fracture" ] } ], "distributor_city": "", "date_report": "20211117", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "PK", "manufacturer_contact_city": "CARLSBAD", "mdr_report_key": "12833494", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20211021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "54000", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "CLEARPATH ORTHODONTICS", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "280934334", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ORTHO ORGANIZERS, INC. RECEIVED A COMPLAINT ON (B)(6) 2021 FROM (B)(6) IN (B)(6), NV REGARDING A PATIENT WHO EXPERIENCED TOOTH FRACTURE DURING TREATMENT WITH THE REVEAL CLEAR ALIGNERS. ORTHO ORGANIZERS REQUESTED THE DEVICE FOR EVALUATION, BUT IT WAS NOT RECEIVED IN TIME FOR THIS REPORT. FOR THIS REASON, CONCLUSIONS ABOUT CAUSALITY ARE NOT ABLE TO BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED IF THE DEVICE IN QUESTION IS RETURNED." }, { "mdr_text_key": "280934336", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE PATIENT ADVISED THE DOCTOR'S OFFICE THAT HER TEETH HAVE CHIPPED DURING TREATMENT WITH THE REVEAL CLEAR ALIGNERS. THE COMPLAINT AND SUPPORTING DOCUMENTATION STATE THAT THE (B)(6)-YEAR OLD PATIENT REPORTED TO THE DOCTOR'S OFFICE THAT HER LOWER TEETH HAD CHIPPED AFTER THE FIRST ALIGNER TRAY WAS SWITCHED. SHE REPORTED THAT UPPER TOOTH #8 CHIPPED ON INSIDE CORNER AND LOWER TOOTH # 25 CHIPPED ON TOP OF OCCLUSAL MARGIN DUE TO THE TOOTH MOVEMENT AFTER WEARING THE ALIGNERS FOR ONLY A FEW WEEKS. THE RETURNED QUESTIONNAIRE DID NOT INDICATE WHETHER THE PATIENT WORE THE ALIGNERS AT THE TIME. IN A LETTER SUBMITTED BY THE PATIENT, SHE DESCRIBED THAT - AFTER TWO WEEKS OF WEARING THE ALIGNERS - HER UPPER TEETH WOULD HIT HER LOWER TEETH WHEN SHE REMOVED THE ALIGNERS TO EAT. SHE WENT ON TO SAY THAT ONE WEEK LATER TWO OF HER TEETH HAD CHIPPED. WHILE THE PATIENT DID NOT SPECIFICALLY MENTION THIS, IT CAN BE REASONABLY ASSUMED THAT HER TEETH CHIPPED AFTER SHE REMOVED THE ALIGNERS AND WHILE SHE WAS EATING." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "6-N MAIN BOULEVARD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "92008", "manufacturer_contact_exchange": "760", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }