{ "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": "CAESAREA BUSINESS PARK", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "8200 CORAL SEA STREET NE MVS21", "manufacturer_g1_city": "CAESAREA HEFA,IL", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "76352656", "event_type": "Injury", "report_number": "3005075696-2025-00394", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251202", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20251017", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55112", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7635265677", "noe_summarized": "1", "manufacturer_contact_l_name": "ELLIS", "source_type": [ "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20251202", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2315101", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251202", "brand_name": "MAZOR X SYSTEM", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAZOR ROBOTICS LTD", "manufacturer_d_address_1": "1 HAESHEL STREET. (BUILDING C)", "manufacturer_d_address_2": "CAESAREA BUSINESS PARK", "manufacturer_d_city": "CAESAREA HEFA,IL", "manufacturer_d_state": "", "manufacturer_d_zip_code": "30798", "manufacturer_d_zip_code_ext": "30", "manufacturer_d_country": "IS", "manufacturer_d_postal_code": "3079830", "device_operator": "HEALTH PROFESSIONAL", "model_number": "TPL0059", "catalog_number": "TPL0059", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "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": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20251223", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "30", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7635", "patient": [ { "patient_sequence_number": "1", "date_received": "20251202", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Insufficient Information", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20251202", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "23693733", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20251111", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "30798", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MAZOR ROBOTICS LTD", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "386596572", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NAVARRO-GARCIA DE LLANO, J. P., RIOS-ZERMENO, J., ROBERTS, A. P., IYER, H. G., SANCHEZ-GARAVITO, J. E., SAFA, A., MARTIN DEL CAMPO, I., GRAEPEL, S., PATTERSON, J. S., WHITE, K. E., BOJAXHI, E., NAVARRO-RAMIREZ, R., QUIÑONES-HINOJOSA, A., AKINDURO, O. O., BUCHANAN, I. A., CHEN, S. G., <(>&<)> ABODE-IYAMAH, K. (2025). SPINAL VERSUS GENERAL ANESTHESIA IN ROBOTIC MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION: A COMPARATIVE STUDY ON SURGICAL OUTCOMES. JOURNAL OF NEUROSURGERY: SPINE, 1¿9. HTTPS://DOI.ORG/10.3171/2025.6.SPINE25442 SUMMARY OBJECTIVE: THE IMPLEMENTATION OF ROBOTICS AND SPINAL ANESTHESIA (SA) IN SPINE SURGERY IS RAPIDLY EXPANDING, OFFERING SIGNIFICANT BENEFITS FOR AN INCREASINGLY COMPLEX AND AGING PATIENT POPULATION WITH DEGENERATIVE SPINAL DISEASE. HERE, THE AUTHORS PRESENT THE LARGEST COHORT TO DATE EVALUATING THE COMBINED USE OF THESE TWO TECHNIQUES IN MINIMALLY INVASIVE (MIS) TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). METHODS: THE AUTHORS RETROSPECTIVELY ANALYZED SURGICAL OUTCOMES OF A SERIES OF PATIENTS WHO UNDERWENT ROBOT-ASSISTED (RA)¿MIS TLIF UNDER SA AND GENERAL ANESTHESIA (GA) AT THEIR INSTITUTION FROM 2018 TO 2024. PRIMARY OUTCOMES INCLUDED OPERATIVE TIMES AND POSTOPERATIVE PAIN INTENSITY. SECONDARY OUTCOMES INCLUDED ESTIMATED BLOOD LOSS, INTRAOPERATIVE COMPLICATIONS, POSTOPERATIVE FUNCTIONAL STATUS, LENGTH OF STAY (LOS), AND DISCHARGE STATUS. TO ADDRESS POTENTIAL CONFOUNDERS, A 1:1 PROPENSITY SCORE¿MATCHING AND REGRESSION ANALYSIS WAS IMPLEMENTED. STATISTICAL ANALYSES WERE CONDUCTED USING PYTHON. RESULTS: A TOTAL OF 209 PATIENTS UNDERWENT RA-MIS TLIF, WITH 31 (14.83%) RECEIVING SA AND 178 (85.17%) GA. AFTER PROPENSITY SCORE MATCHING, THE SA COHORT DEMONSTRATED SIGNIFICANTLY SHORTER MEDIAN TOTAL OPERATING ROOM (OR) TIME, TOTAL PROCEDURE TIME, TIME FROM ENTERING THE OR TO SKIN INCISION, AND TIME FROM CLOSURE TO LEAVING THE OR (ALL P <(><<)> 0.01). ADDITIONALLY, POSTOPERATIVE PAIN SCORES WERE SIGNIFICANTLY LOWER (P <(> <<)> 0.01), AND LOS WAS SIGNIFICANTLY SHORTER (P <(><<)> 0.01) IN THE SA COHORT. REGRESSION ANALYSIS, ADJUSTING FOR POTENTIAL CONFOUNDERS, FURTHER SUPPORTED THESE FINDINGS. CONCLUSIONS: RA-MIS TLIF FUSION UNDER SA IS A SAFE AND EFFECTIVE APPROACH THAT SIGNIFICANTLY REDUCES OPERATIVE TIME, POSTOPERATIVE PAIN, AND HOSPITAL LOS IN PATIENTS UNDERGOING SURGERY FOR DEGENERATIVE LUMBAR SPINE DISEASE. REPORTED EVENT TWO HUNDRED NINE PATIENTS UNDERWENT RA-MIS TLIF, WITH THIRTY ONE RECEIVING SA AND A HUNDRED SEVENTY EIGHT RECEIVING GA, TO ADDRESS D EGENERATIVE DISC DISEASE. IN THE GA GROUP, IT WAS REPORTED THAT THERE WERE FIVE COMPLICATIONS. THERE WERE THREE CASES WHERE NEW POST OPERATIVE MOTOR DEFICIT OCCURRED AND THIRTEEN CASES WHERE NEW POST OPERATIVE SENSORY DEFICIT OCCURRED. IN THE SA GROUP, IT WAS NOTED THAT THERE WERE THREE CASES OF NEW POST OPERATIVE SENSORY DEFICIT." }, { "mdr_text_key": "386596573", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DIGITAL SHARING OF THE ARTICLE WOULD BE IN VIOLATION OF COPYRIGHT PERMISSION. A.1-A.5) PATIENT INFORMATION WAS INCLUDED IN THE JOURNAL. A.2. THIS VALUE IS THE MEAN AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.4. THE PATIENT'S WEIGHT WAS NOT PROVIDED. A.5.A <(>&<)> B. THIS VALUE REFLECTS THE RACE/ETHNICITY OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS PUBLISHED ONLINE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. B.5. INCLUDED THE ARTICLE CITATION D.4. THE SYSTEM SERIAL NUMBER WAS NOT PROVIDED IN THE JOURNAL ARTICLE. H.3. NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. H.4. DEVICE MANUFACTURING DATE WAS UNAVAILABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "1 HAESHEL STREET. (BUILDING C)", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55112", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }