{ "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": "3009189869-2026-00009", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260604", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20260508", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "75034", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "8002857090", "noe_summarized": "1", "manufacturer_contact_l_name": "DIVAKAR", "source_type": [ "Distributor" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "75034", "manufacturer_g1_state": "TX", "reporter_country_code": "US", "manufacturer_contact_area_code": "800", "date_added": "20260604", "manufacturer_contact_f_name": "VAREESHA", "device_date_of_manufacturer": "20191226", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1459330", "implant_date_year": "2020", "date_removed_year": "2026", "serviced_by_3rd_party_flag": "U", "date_received": "20260604", "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": "090319.02B", "catalog_number": "090319.02B", "lot_number": "JI82564", "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": "20260626", "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": "20260604", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "69 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain" ] } ], "distributor_city": "", "date_report": "20260604", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "FRISCO", "mdr_report_key": "25394676", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20251209", "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": "403323865", "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." }, { "mdr_text_key": "403323866", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED TO THE MANUFACTURER THAT A 4WEB CUSTOM-MADE DEVICE WAS EXPLANTED APPROXIMATELY SIX AND A HALF YEARS FOLLOWING THE INITIAL SURGERY. THE PATIENT REPORTEDLY PRESENTED WITH PAIN. IT WAS REPORTED THAT JOINTS AROUND THE IMPLANT ERODED CAUSING THE IMPLANT TO SHIFT OUT OF POSITION. THE PATIENT HAD UNDERGONE A PRIOR ANKLE REPLACEMENT PROCEDURE. THE 4WEB DEVICE WAS EXPLANTED IN '(B)(6) 2026 AND REPLACED WITH ANOTHER 4WEB CUSTOM-MADE DEVICE." } ], "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": "" } ] }