{ "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": "2026-08-05", "results": { "skip": 0, "limit": 1, "total": 5 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "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": "9681199-2011-00001", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20110331", "manufacturer_address_2": "", "pma_pmn_number": "K951778", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NOT APPLICABLE", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "GM", "manufacturer_contact_area_code": "", "date_added": "20110419", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20110331", "brand_name": "DEGUDENT U", "generic_name": "", "manufacturer_d_name": "DEGUDENT GMBH", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "HANAU", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "GM", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "5313020002", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "date_returned_to_manufacturer": "20110301", "device_report_product_code": "EJT", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Alloy, Gold-Based Noble Metal", "medical_specialty_description": "Dental", "regulation_number": "872.3060", "device_class": "2", "registration_number": [ "9681199" ], "fei_number": [ "3003999430" ] } } ], "product_problems": [ "Fracture" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20110331", "sequence_number_treatment": [ "DUCERAM KISS" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Tooth Fracture" ] } ], "distributor_city": "", "date_report": "20110301", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2058955", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20110301", "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": "20086304", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IN THIS EVENT, IT WAS REPORTED THAT A FOUR-PART DEGUDENT U BRIDGE FRACTURED IN A PT'S MOUTH AFTER FOUR YEARS IN PLACE. A TOOTH UNDER THE BRIDGE ALSO FRACTURED. AS A RESULT, THE TOOTH WAS RESTORED; NO FURTHER ISSUES WERE REPORTED AFTER RESTORATION." }, { "mdr_text_key": "19944841", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INVESTIGATION SHOWED THAT THE FRACTURE WAS CAUSED EXCLUSIVELY BY USE ERROR. AS SUCH, THERE IS NO INDICATION THAT THE DEVICE INVOLVED MALFUNCTIONED. HOWEVER, SINCE HEALTHY TOOTH STRUCTURE WAS DAMAGED AND INTERVENTION WAS REQUIRED AS A RESULT, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS RETURNED AND MACROSCOPIC INSPECTION AND MICROSECTION EVALUATIONS WERE PERFORMED. MASSIVE ABRASION, NUMEROUS BLOW HOLES, AND BLOW HOLES IN SOLDER JOINT WERE NOTED. THE CUSTOMER WAS ADVISED TO CHECK AND IMPROVE CASTING PARAMETERS IN ORDER TO ATTAIN BETTER CASTING QUALITY. IN THE CASE OF MASSIVE ABRASION, THE BRIDGE SHOULD BE STABILIZED BY ENLARGING THE CONNECTOR CROSS SECTION AND USING A LINGUAL METAL GARLAND. THE SOLDER FISSURE SHOULD BE KEPT BETWEEN 0.05 AND 0.2 MM." } ], "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": "" } ] }