{ "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": "1723170-2019-03075", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20190607", "manufacturer_address_2": "", "pma_pmn_number": "K180307", "date_of_event": "20190509", "reprocessed_and_reused_flag": "N", "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": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20190607", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "472111", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190607", "brand_name": "MAZOR X SYSTEM", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MEDTRONIC NAVIGATION, INC", "manufacturer_d_address_1": "826 COAL CREEK CIRCLE", "manufacturer_d_address_2": "", "manufacturer_d_city": "LOUISVILLE", "manufacturer_d_state": "CO", "manufacturer_d_zip_code": "80027", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "80027", "device_operator": "HEALTH PROFESSIONAL", "model_number": "TPL0059", "catalog_number": "TPL0059", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20190604", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "07290109183213", "udi_public": "07290109183213", "openfda": { "device_name": "Orthopedic 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": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/21/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20190607", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " R" ], "patient_age": "50 YR", "patient_sex": "", "patient_weight": "91", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Neurological Deficit/Dysfunction", "Neurological Deficit/Dysfunction" ] } ], "distributor_city": "", "date_report": "20190906", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8680259", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190509", "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": "147378541", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "147378542", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "MEDTRONIC RECEIVED INFORMATION FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT THEY WERE DOING THE FIRST CASE WITH THE DEVICE ON THE DAY OF THE REPORT. THEY STARTED WITH L45 AND L3-4 INTRALIFS. THE L4-5 LEVEL WAS CONDUCTED AS A TRUE INTRALIF UTILIZING THE TRAJECTORY OF THE ROBOT ARM. THE HCP REMOVED THE INTERNAL DISSECTOR AND PLACED A 7.5 MM AND 6.5 MM DILATOR FROM JOIMAX AND PASSED A K-WIRE THROUGH IT. THEN, THEY TOOK OUT THE DILATORS AND PASSED THROUGH A GLOBUS 8/5 MM TUBE THAT WAS SURE-TRACKED. THE HCP USED THE ROBOT TO GUIDE TO BOTH DISC SPACES. IT WAS NOTED THAT THE ROBOT SYSTEM AND NAVIGATION PERFORMED AS PLANNED. THE DILATOR WAS ACCURATE ON THE NAVIGATION WHEN USED WITH THE INSTRUMENTS. THE PATIENT HAD A LEFT L3 NEUROPRAXIA. THE PSOAS BELLY WAS MORE POSTERIOR THAN THE HCP THOUGHT. IT WAS NOTED THAT THE INTRALIF MAY NEED NEUROMONITORING. THE LEFT L4-5 WENT SMOOTHLY BUT THE HCP DECIDED TO BE A LITTLE EXTRA FORAMINAL FOR L3-4. IT WAS NOTED THE HCP MAY HAVE CONVERTED THE INTRALIF ALMOST INTO A ROBOT-GUIDED ENDOSCOPIC XLIF. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED OR ANTICIPATED AS A RESULT OF THE EVENT." }, { "mdr_text_key": "190739889", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVALUATION OF THE RETURNED SOFTWARE EXPORT FILES FOUND NO EVIDENCE OF INACCURACY OF THE SYSTEM. THE SYSTEM HAS NOT DEVIATED FROM ITS DESIGNED FUNCTIONALITY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "190739890", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL INDICATED THAT WHILE THERE IS NO EVIDENCE OF MALFUNCTION OF THE DEVICE, AND ALL TRAJECTORIES WERE ASSESSED AS ACCURATE BOTH INTRA-OPERATIVELY AS WELL AS ON POST-HOC EVALUATION, THE PATIENT DID REQUIRE A REVISION SURGERY." } ], "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": "09/06/2019" } ] }