{ "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": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "SUITE 620", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MRS.", "manufacturer_contact_state": "TX", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "SUITE 620", "manufacturer_g1_city": "FRISCO", "manufacturer_contact_address_1": "2801 NETWORK BOULEVARD", "manufacturer_contact_pcity": "80028570", "event_type": "Injury", "report_number": "3009189869-2026-00013", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260715", "manufacturer_address_2": "", "pma_pmn_number": "", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "75034", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "8002857090", "noe_summarized": "1", "manufacturer_contact_l_name": "DIVAKAR", "source_type": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "75034", "manufacturer_g1_state": "TX", "reporter_country_code": "US", "manufacturer_contact_area_code": "800", "date_added": "20260715", "manufacturer_contact_f_name": "VAREESHA", "device_date_of_manufacturer": "20241018", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "70092", "implant_date_year": "2024", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20260715", "brand_name": "", "generic_name": "PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT", "manufacturer_d_name": "4WEB, INC.", "manufacturer_d_address_1": "2801 NETWORK BOULEVARD,", "manufacturer_d_address_2": "SUITE 620", "manufacturer_d_city": "FRISCO", "manufacturer_d_state": "TX", "manufacturer_d_zip_code": "75034", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "75034", "device_operator": "HEALTH PROFESSIONAL", "model_number": "082924.24A", "catalog_number": "082924.24A", "lot_number": "JI48100", "other_id_number": "", "device_availability": "No", "device_report_product_code": "QNN", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Prosthesis, Total Talus Replacement, Metal", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "f" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260716", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "5", "manufacturer_city": "", "manufacturer_contact_phone_number": "8002", "patient": [ { "patient_sequence_number": "1", "date_received": "20260715", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Disability" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Arthritis", "Necrosis", "Pain" ] } ], "distributor_city": "", "date_report": "20260715", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "FRISCO", "mdr_report_key": "25828494", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260617", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "75034", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "4WEB, INC.", "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": "407548424", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING A ROUTINE ANNUAL SURVEY CONDUCTED BY 4WEB PATIENT SPECIFIC IMPLANTS TEAM, A SURGEON REPORTED THAT A PATIENT ELECTED FOR AMPUTATION BELOW-THE-KNEE. PER INFORMATION RECEIVED, THE SUBTALAR FUSION WAS FELT TO BE UNSTABLE AND A PERSISTENT SOURCE OF PAIN AND DISABILITY LEADING TO THE DECISION. THE PATIENT HAD PRE-EXISTING ANKLE AND JOINT SUB-TALAR ARTHRITIS AND AVASCULAR NECROSIS OF THE TALUS. THE DATE OF AMPUTATION IS UNKNOWN." }, { "mdr_text_key": "407548425", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE SUBJECT OF THIS FILING WAS UNIQUELY DESIGNED FOR THIS PATIENT'S SPECIFIC PATHOLOGY BY THE PRESCRIBING PHYSICIAN. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THE PRODUCTION RECORDS WERE REVIEWED FOR THE PRODUCT INVOLVED, NO MANUFACTURING DEFICIENCIES WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THERE IS NO EVIDENCE THAT THE DEVICE CONTRIBUTED TO THE INCIDENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "2801 NETWORK BOULEVARD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "75034", "manufacturer_contact_exchange": "800", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }