{ "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": "2026-10-13", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "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": "MW5171504", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250616", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250426", "reprocessed_and_reused_flag": "", "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": "EZ", "manufacturer_contact_area_code": "", "date_added": "20250618", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1809381", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250616", "brand_name": "TERA HARZ CLEAR", "generic_name": "ALIGNER, SEQUENTIAL", "manufacturer_d_name": "GRAPHY 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": "", "model_number": "TC-85DAC", "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": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Aligner, Sequential", "medical_specialty_description": "Dental", "regulation_number": "872.5470", "device_class": "2" } } ], "product_problems": [ "Patient-Device Incompatibility" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250820", "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": "20250616", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " R" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Dyspnea", "Hypersensitivity/Allergic reaction", "Discomfort", "Sore Throat", "Swelling/ Edema", "Dyspnea", "Hypersensitivity/Allergic reaction", "Discomfort", "Sore Throat", "Swelling/ Edema" ] } ], "distributor_city": "", "date_report": "20250604", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "22213172", "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": "372892728", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "SUBMITTED THIS REPORT BY (B)(6) ON BEHALF OF (B)(6) (ORTHODONTIST PRACTICING IN (B)(6)). DR. (B)(6) STATED THAT HE ATTENDED THE (B)(6) ANNUAL SESSION 2025 HELD IN (B)(6) FROM (B)(6) 2025. DURING THE CONFERENCE, HE PERSONALLY REPORTED PATIENT SAFETY CONCERNS TO A REPRESENTATIVE FROM GRAPHY INC., THE MANUFACTURER OF THE TERA HARZ CLEAR (510K # K240597; PRODUCT CODE NXC) MODELS TC-85DAC, TR-07, AND TA-28. ACCORDING TO DR. (B)(6), APPROXIMATELY 1 IN EVERY 4 TO 5 OF HIS PATIENTS TREATED WITH THE TERA HARZ CLEAR ALIGNER MEDICAL DEVICE EXPERIENCED ADVERSE REACTIONS SHORTLY AFTER BEGINNING USE. THE REPORTED SYMPTOMS BY HIS PATIENTS INCLUDED: DYSPNEA, LIP SWELLING/EDEMA, GUM SWELLING/EDEMA, AND SORE THROAT/THROAT DISCOMFORT. THE AFFECTED PATIENTS REPORTEDLY SELF-MEDICATED WITH OVER-THE-COUNTER ANTIHISTAMINES TO MANAGE THESE SYMPTOMS. DR. (B)(6) CONVEYED THESE FINDINGS DIRECTLY TO A GRAPHY INC. REPRESENTATIVE DURING THE (B)(6) CONFERENCE. THE REPRESENTATIVE COLLECTED DR. (B)(6) CONTACT INFORMATION AND INFORMED HIM THAT THE COMPANY WOULD FOLLOW-UP REGARDING THESE REPORTED INCIDENTS. REFERENCE REPORTS: MW5171505, MW5171506." } ], "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": "" } ] }