{ "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": "N", "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": "3005075696-2017-00008", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20171207", "manufacturer_address_2": "", "pma_pmn_number": "K163221", "date_of_event": "20171102", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "DISTRIBUTOR" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "date_facility_aware": "20171108", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20171207", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "876085", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20171207", "brand_name": "MAZOR X", "generic_name": "MAZOR X", "manufacturer_d_name": "MAZOR ROBOTICS LTD.", "manufacturer_d_address_1": "5 SHACHAM ST.", "manufacturer_d_address_2": "NORTH INDUSTRIAL PARK", "manufacturer_d_city": "CAESAREA, ISRAEL", "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": "NA", "other_id_number": "", "device_availability": "No", "device_report_product_code": "HAW", "device_age_text": "11 MO", "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": [ "Missing Value Reason", "Missing Value Reason" ], "reporter_state_code": "CO", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250821", "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": "20171207", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Disability" ], "patient_age": "69 YR", "patient_sex": "", "patient_weight": "80", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Patient Problem/Medical Problem", "Patient Problem/Medical Problem" ] } ], "distributor_city": "", "date_report": "20171207", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7097851", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20171108", "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": "94193402", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "EXEMPTION NUMBER E2017043." }, { "mdr_text_key": "94193403", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON (B)(6) 2017 (REPORTED TO MAZOR ON (B)(4) 2017) THE MAZOR X SYSTEM WAS USED AT (B)(6) FOR A L4-S1 SURGERY. THE REPORTED EVENT: \"WE HAD A SCREW BREACH MEDIAL DURING THE CASE AT SCRIPPS MEMORIAL ON (B)(6) WITH DR. (B)(6). AT THE TIME, DR. (B)(6) REMOVED THE SCREW AND REDIRECTED FREEHAND. THE NEW SCREW WAS CONFIRMED VIA FLURO AND NEUROMONITORING. ALL SIGNALS LEAVING THE CASE WERE OK. HOWEVER, DR. (B)(6) INFORMED ME LAST NIGHT THAT THE PATIENT WOKE UP WITH SOME LEFT SIDED SYMPTOMS AND FOOT DROP.\" UPDATE FROM (B)(6): PURSUANT TO DISCUSSION WITH THE SURGEON, HE HAS INFORMED THAT A COUPLE OF DAYS AFTER THE SURGERY THE PAIN HAS LESSENED BUT THE PATIENT STILL HAD PALSY." } ], "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": "" } ] }