{ "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": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "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": "3005075696-2018-00033", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20181209", "manufacturer_address_2": "", "pma_pmn_number": "K163221", "date_of_event": "20181107", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "date_facility_aware": "20181108", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20181209", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "984814", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20181209", "brand_name": "MAZOR X SYSTEM", "generic_name": "STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAZOR ROBOTICS LTD.", "manufacturer_d_address_1": "POB 3104, 5 SHACHAM ST.", "manufacturer_d_address_2": "NORTH INDUSTRIAL PARK", "manufacturer_d_city": "CAESAREA,", "manufacturer_d_state": "", "manufacturer_d_zip_code": "30889", "manufacturer_d_zip_code_ext": "00", "manufacturer_d_country": "IS", "manufacturer_d_postal_code": "3088900", "device_operator": "HEALTH PROFESSIONAL", "model_number": "TPL0059", "catalog_number": "TPL0059", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "HAW", "device_age_text": "1 YR", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "07290109180465", "udi_public": "07290109180465", "openfda": { "device_name": "Neurological Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "CO", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20181209", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "42 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Patient Problem/Medical Problem", "No Known Impact Or Consequence To Patient", "Foreign Body In Patient", "Patient Problem/Medical Problem", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20181208", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8145089", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20181108", "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": "129746849", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "SEVERAL ATTEMPTS WERE MADE TO SUBMIT THIS ADVERSE EVENT (4 FAILURES WERE RECEIVED) DUE TO ISSUES WITH CERTIFICATE RENEWAL AS WELL AS ISSUES RELATED TO THE ESUBMITTER (ERROR IN METHOD AND CONCLUSION CODE, ALTHOUGH DO NOT APEAR IN THE ACTUAL ESUBMITTER REPORT). FDA HELP DESK WAS INFORMED AND THE ISSUE IS CURRENTLY IN PROCESS (TICKET IS OPENED)." }, { "mdr_text_key": "129746850", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A COMPLAINT WAS RECEIVED ON (B)96) 2018 FROM (B)(6). DESCRIBING A SITUATION IN WHICH A TRAJECTORY DEVIATION OCCURRED AND RESULTED IN PENETRATION OF CEMENT INTO THE CANAL. THE SURGERY CONTINUED AS PLANNED AND THE PATIENT WAS FINE." } ], "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": "" } ] }