{ "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": 20 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "SUITE 2160", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "NC", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "SUITE 2160", "manufacturer_g1_city": "DURHAM", "manufacturer_contact_address_1": "4001 NC HWY 54", "manufacturer_contact_pcity": "98488805", "event_type": "Injury", "report_number": "3014833750-2023-00003", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20231006", "manufacturer_address_2": "", "pma_pmn_number": "520(B) EXMPT", "date_of_event": "20220824", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "27709", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9848880593", "noe_summarized": "1", "manufacturer_contact_l_name": "WU", "source_type": [ "Study", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "27709", "manufacturer_g1_state": "NC", "reporter_country_code": "US", "manufacturer_contact_area_code": "984", "date_added": "20231010", "manufacturer_contact_f_name": "TIFFANY", "device_date_of_manufacturer": "20210112", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1711137", "implant_date_year": "2021", "date_removed_year": "2022", "serviced_by_3rd_party_flag": "N", "date_received": "20231006", "brand_name": "RESTOR3D", "generic_name": "PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT", "manufacturer_d_name": "RESTOR3D", "manufacturer_d_address_1": "4001 NC HWY 54", "manufacturer_d_address_2": "SUITE 2160", "manufacturer_d_city": "DURHAM", "manufacturer_d_state": "NC", "manufacturer_d_zip_code": "27709", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "27709", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210405", "model_number": "9000-0003-B", "catalog_number": "9000-0003-B", "lot_number": "20201223-DMP-C-01", "other_id_number": "", "device_availability": "No", "device_report_product_code": "QNN", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "3014833750" ], "fei_number": [ "3014833750" ], "device_name": "Prosthesis, Total Talus Replacement, Metal", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "f" } } ], "product_problems": [ "Patient-Device Incompatibility", "Patient-Device Incompatibility" ], "reporter_state_code": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250808", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9848", "patient": [ { "patient_sequence_number": "1", "date_received": "20231006", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "36 YR", "patient_sex": "Male", "patient_weight": "101 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Arthritis", "Arthralgia", "Arthritis", "Arthralgia" ] } ], "distributor_city": "", "date_report": "20230925", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "DURHAM", "mdr_report_key": "17890770", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220624", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "27709", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "RESTOR3D", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "325230189", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "WHEN REVIEWING RECORDS FOLLOWING REPORTING OF THE ADVERSE EVENT, RESTORED DISCOVERED THIS DEVICE WAS ASSOCIATED WITH A PREVIOUS INTERNAL COMPLAINT THAT THE TALAR DOME OF THE DEVICE WAS THE INCORRECT SIDE. RESTORED PERFORMED A HEALTH HAZARD ASSESSMENT AT THE TIME WITH THE CLINICIAN, AND DETERMINED THE DEVICE POSED NO ADDITIONAL RISK OF SUBSEQUENT SURGICAL INTERVENTION, AS THE MISMATCH WOULD LIKELY ONLY OCCUR AT THE FAR RANGES OF THE PATIENT'S RANGE OF MOTION." }, { "mdr_text_key": "325230190", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IN A RETROSPECTIVE STUDY, RESTOR 3D OBTAINED INFORMATION OF ADVERSE EVENTS REGARDING THE STUDY DEVICE. REPORTED EVENT IS THE FOLLOWING: PATIENT EXPERIENCED REVISION ANKLE ARTHROPLASTY WITH SUBTALAR JOINT ARTHRODESIS (STJ) FOR PERSISTENT PAIN AND ARTHRITIS AT THE SUB TALAR JOINT WITH CYSTIC CHANGES PROXIMAL TO TIBIAL IMPLANT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "4001 NC HWY 54", "distributor_zip_code": "", "manufacturer_contact_postal_code": "27709", "manufacturer_contact_exchange": "984", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }