{ "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": "2026-07-07", "results": { "skip": 0, "limit": 1, "total": 1424593 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "OTHER", "report_to_fda": "N", "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": "3008261720-2020-02138", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K163194", "date_of_event": "20191129", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "report_date": "20200323", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "DENTIST", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "CONSUMER", "DISTRIBUTOR", "FOREIGN", "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "date_facility_aware": "20200427", "manufacturer_g1_state": "", "reporter_country_code": "CO", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "465490", "implant_date_year": "2019", "date_removed_year": "2019", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "GM HELIX IMPLANT 5.0X13 MM", "generic_name": "ENDOSSEOUS DENTAL IMPLANT", "manufacturer_d_name": "NEODENT - JJGC S.A.", "manufacturer_d_address_1": "AV. JUSCELINO KUBITSCHEK DE", "manufacturer_d_address_2": "OLIVEIRA, 3291 CIC", "manufacturer_d_city": "CURITIBA", "manufacturer_d_state": "PR", "manufacturer_d_zip_code": "81270", "manufacturer_d_zip_code_ext": "-200", "manufacturer_d_country": "BR", "manufacturer_d_postal_code": "81270-200", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20230802", "model_number": "109.956", "catalog_number": "109.956", "lot_number": "800352177", "other_id_number": "", "device_availability": "No", "device_report_product_code": "DZE", "device_age_text": "15 MO", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "07899878024279", "udi_public": "07899878024279", "openfda": { "registration_number": [ "3008261720" ], "fei_number": [ "3008261720" ], "device_name": "Implant, Endosseous, Root-Form", "medical_specialty_description": "Dental", "regulation_number": "872.3640", "device_class": "2" } } ], "product_problems": [ "Failure to Osseointegrate", "Failure to Osseointegrate" ], "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": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Tissue Damage", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20200427", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "date_report_to_manufacturer": "20200323", "manufacturer_contact_city": "", "mdr_report_key": "10000049", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200323", "manufacturer_name": "", "report_source_code": "Manufacturer 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": "188969307", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE INFORMATION PROVIDED IN THIS REPORT WAS BASED ON INFORMATION GIVEN BY THE DENTIST IN NEODENT¿S PRODUCTS WARRANTY FORM THAT WAS RECORDED IN THE SYSTEM AND IS USED BY BOTH THE MANUFACTURER AND THE SUBSIDIARY. THE ORIGINAL COMPLAINT AND THE PRODUCT WERE RECEIVED BY THE SUBSIDIARY AND DID NOT ARRIVE IN THE MANUFACTURER YET. WHEN THIS HAPPENS, A NEW EVALUATION OF THE COMPLAINT WILL BE CARRIED OUT AND, IF NECESSARY, A NEW FOLLOW-UP REPORT WILL BE SEND." }, { "mdr_text_key": "188969308", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "(B)(4)¿ THE DENTIST REPORTED THAT ALMOST 02 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED." } ], "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": "" } ] }