{ "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": "3005075696-2025-00292", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250624", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20250506", "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": [ "Foreign", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "SN", "manufacturer_contact_area_code": "763", "date_added": "20250624", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1198155", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250624", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250826", "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": "20250624", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "68 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20250624", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "22321773", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250605", "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": "373335981", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "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 NO PROVIDED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS ACCEPTED 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." }, { "mdr_text_key": "373335982", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "WAN, J. J., YEO, J., CHEW, Z., & DINESH, S. K. (2025). COMPARATIVE COST-EFFECTIVENESS ANALYSIS BETWEEN NAVIGATED ROBOT-ASSISTED PLATFORMS AND O-ARM NAVIGATION IN MINIMALLY INVASIVE TRANSFORAMINAL INTERBODY FUSION (MIS-TLIF). THE SPINE JOURNAL. HTTPS://DOI.OR G/10.1016/J.SPINEE.2025.05.027 SUMMARY: BACKGROUND CONTEXT: MINIMAL INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION(TLIF) IS AN INCREASINGLY COMMON PROCEDURE USED IN TREATING DEGENERATIVE LUMBAR SPINE CONDITIONS. ADVANCEMENT OF ROBOT-ASSISTED TECHNOLOGY HAS IMPROVED ACCURACY OF INSTRUMENTATION WITH SMALLER INCISIONS, RESULTING IN BETTER SURGICAL OUTCOMES AND SHORTER HOSPITAL STAY. PURPOSE: THIS STUDY AIMS TO ASSESS COST EFFECTIVENESS OF ROBOT-ASSISTED MINIMALLY INVASIVE TLIF(RA-TLIF) IN OUR INSTITUTION; AND COMPARE PATIENT OUTCOMES WITH CONVENTIONAL O-ARM NAVIGATED MINIMALLY INVASIVE TLIF (ON-TLIF). DESIGN: SINGLE-CENTER, RETROSPECTIVE CASE COHORT SERIES BETWEEN ELECTIVE RA-TLIF AND ON-TLIF GROUPS. PATIENT SAMPLE: ABOUT 27 PATIENTS WHO UNDERWENT ELECTIVE RA-TLIF AND CONTROL GROUP OF 50 ELECTIVE ON-TLIF. OUTCOME MEASURES: OPERATIVE DURATION, LENGTH OF INPATIENT STAY, POSTOPERATIVE AMBULATION, RATES OF INTRAOPERATIVE AND POSTOPERATIVE COMPLICATIONS AND INPATIENT COSTS. METHODS: PATIENT DEMOGRAPHICS (AGE, GENDER, CHARLSON CO-MORBIDITY INDEX (CCI), BMI), POSTOPERATIVE OUTCOMES AND INPATIENT COSTS WERE USED IN COMPARATIVE ANALYSIS. RESULTS: NO SIGNIFICANT DIFFERENCES WERE FOUND IN PATIENT DEMOGRAPHICS, BASELINE CCI, OPERATIVE DURATION, LENGTH OF INPATIENT STAY, AND POSTOPERATIVE AMBULATION. RATES OF INTRAOPERATIVE AND POSTOPERATIVE COMPLICATIONS WERE SIMILAR BETWEEN THE 2 GROUPS (OR=0.93, P=.112). INPATIENT HOSPITALIZATION COSTS WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN BOTH GROUPS. CONCLUSION: RA-TLIF HAS SHOWN SIMILAR COST-EFFECTIVENESS AND SURGICAL OUTCOMES IN COMPARISON WITH CONVENTIONAL ON-TLIF. WHILE NOT DEMONSTRATED IN THIS STUDY, RA-TLIF HAS BEEN ASSOCIATED WITH ALONGER OPERATIVE DURATION DUE TO HIGHER LEARNING CURVE, SET-UP TIME AND POSSIBLE HARDWARE/ SOFTWARE ERRORS. ULTIMATELY, MORE CASE NUMBERS ARE REQUIRED FOR THE OPERATING STAFF TO OVERCOME THIS LEARNING CURVE TO ACHIEVE OPTIMAL RESULTS. SPINE SURGICAL CENTERS EVALUATING BOTH TECHNIQUES MAY CONSIDER EITHER WITH CONFIDENCE. © 2025 ELSEVIER INC. ALL RIGHTS ARE RESERVED, INCLUDING THOSE FOR TEXT AND DATA MINING, AI TRAINING, AND SIMILAR TECHNOLOGIES. REPORTED EVENTS TWENTY SEVEN PATIENTS UNDERWENT A TLIF TO ADDRESS DEGENERATIVE SPINE CONDITIONS. IT WAS FOUND THAT ONE PATIENT HAD A CAGE POSTERIOR MIGRATION CAUSING LOWER LIMB RADICULAR SYMPTOMS AND UNDERWENT SURGICAL REVISION." } ], "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": "" } ] }