{ "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": 2647 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "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": "1220246-2020-01809", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200429", "manufacturer_address_2": "", "pma_pmn_number": "K172052", "date_of_event": "20200110", "reprocessed_and_reused_flag": "I", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "FOREIGN", "HEALTH PROFESSIONAL", "U" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "GM", "manufacturer_contact_area_code": "", "date_added": "20200429", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "475099", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200429", "brand_name": "DYNANITE NITI STAPLE W/INSTRS 25WX20L", "generic_name": "STAPLE, FIXATION, BONE", "manufacturer_d_name": "ARTHREX, INC.", "manufacturer_d_address_1": "1370 CREEKSIDE BOULEVARD", "manufacturer_d_address_2": "", "manufacturer_d_city": "NAPLES", "manufacturer_d_state": "FL", "manufacturer_d_zip_code": "34108", "manufacturer_d_zip_code_ext": "1945", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "341081945", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20231130", "model_number": "DYNANITE NITI STAPLE W/INSTRS 25WX20L", "catalog_number": "AR-8719DS-2520", "lot_number": "834588923", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "JDR", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00888867288171", "udi_public": "00888867288171", "openfda": { "device_name": "Staple, Fixation, Bone", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3030", "device_class": "2", "registration_number": [ "1220246" ], "fei_number": [ "1220246" ] } } ], "product_problems": [ "Break" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/07/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250731", "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": "20200429", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200429", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10009079", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200407", "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": "190337882", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "COMPLAINT CONFIRMED, ONE LEG OF THE STAPLE WAS FOUND TO BE BROKEN. LIKELY CAUSES OF THE EVENT INCLUDE IMPROPER BONE/JOINT PREP, PATIENT NON-COMPLIANCE AND/ OR NON-UNION OF THE BONES." }, { "mdr_text_key": "190337903", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THE CLAMP BROKE POSTOPERATIVE. UPDATED INFORMATION 10-FEB-2020: IT WAS FURTHER REPORTED THAT THE CLAMP MOST LIKELY BROKE DURING THE PROCESSING AFTER THE SURGERY. UPDATED INFORMATION 07-APR-2020: FURTHER INFORMATION WAS PROVIDED THAT THE ARTICLE BROKE INSIDE THE PATIENT. THEREFORE AN ADDITIONAL SURGERY NEEDED TO BE PERFORMED. IT WAS FURTHER REPORTED THAT THE INITIAL SURGERY WAS A TN-FUSION AND IT WAS PERFORMED ON (B)(6) 2019. THE REVISION WAS PERFORMED ON (B)(6) 2020. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IN ADDITION A SCREW WAS USED." }, { "mdr_text_key": "318008004", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS SUPPLEMENTAL SUBMISSION IS TO CORRECT THE PATIENT IDENTIFIER IN SECTION A1 IN THE ORIGINAL SUBMISSION. THE TYPO ERROR IN SECTION A1 OF 1220246-2020-01809 SHOWED AN IDENTIFIER OF 379134-1-2 BUT SHOULD HAVE BEEN 37934-1-2. THIS IS ONLY REASON FOR THIS SUPPLEMENTAL SUBMISSION." } ], "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": "04/29/2020" } ] }