{ "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": "P.O. BOX 3104", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "7000 CENTRAL AVENUE NE RCW215", "manufacturer_g1_city": "CAESAREA HEFA,IL", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "61227132", "event_type": "Injury", "report_number": "3005075696-2022-00042", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220505", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20211213", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55432", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "6122713209", "noe_summarized": "1", "manufacturer_contact_l_name": "BELMER", "source_type": [ "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079567", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "612", "date_added": "20220506", "manufacturer_contact_f_name": "GLEN", "device_date_of_manufacturer": "20180501", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1693321", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220505", "brand_name": "MAZOR X SYSTEM", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAZOR ROBOTICS LTD", "manufacturer_d_address_1": "5 SHACHAM STREET", "manufacturer_d_address_2": "P.O. BOX 3104", "manufacturer_d_city": "CAESAREA HEFA,IL", "manufacturer_d_state": "", "manufacturer_d_zip_code": "30795", "manufacturer_d_zip_code_ext": "67", "manufacturer_d_country": "IS", "manufacturer_d_postal_code": "3079567", "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": "*", "combination_product_flag": "N", "udi_di": "07290109181158", "udi_public": "07290109181158", "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": "20250821", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "67", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6122", "patient": [ { "patient_sequence_number": "1", "date_received": "20220505", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Infection", "Numbness", "Lethargy", "Unspecified Infection", "Numbness", "Lethargy" ] } ], "distributor_city": "", "date_report": "20220504", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MINNEAPOLIS", "mdr_report_key": "14292153", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220405", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "30795", "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": "294653662", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. THE REPORTED EVENT WAS FROM THE FOLLOWING LITERATURE ARTICLE: DIOGO GARCIA D, AKINDURO O, DE BIASE G, SOUSA-PINTO B, JERRELD D, DHOLAKIA R, BORAH B, NOTTMEIER E, DEEN H, FOX C, BYDON M, CHEN S, QUINONES-HINOJOSA A, ABODE-IYAMAH K. ROBOTIC-ASSISTED VS NONROBOTIC-ASSISTED MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION: A COST-UTILITY ANALYSIS. NEUROSURGERY ONLINE. 90:192¿198, 2022. DOI:10.1227/NEU.0000000000001779. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "294653663", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ABSTRACT: MANAGEMENT OF DEGENERATIVE DISEASE OF THE SPINE HAS EVOLVED TO FAVOR MINIMALLY INVASIVE TECHNIQUES, INCLUDING NONROBOTIC-ASSISTED AND ROBOTIC-ASSISTED MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS-TLIF). VALUE-BASED SPENDING IS BEING INCREASINGLY IMPLEMENTED TO CONTROL RISING COSTS IN THE US HEALTHCARE SYSTEM. WITH AN AGING POPULATION, IT IS FUNDAMENTAL TO UNDERSTAND WHICH PROCEDURE(S) MAY BE MOST COST-EFFECTIVE. TO COMPARE ROBOTIC AND NONROBOTIC MIS-TLIF THROUGH A COST-UTILITY ANALYSIS. WE CONSIDERED DIRECT MEDICAL COSTS RELATED TO SURGICAL INTERVENTION AND TO THE HOSPITAL STAY, AS WELL AS 1-YR UTILITIES. WE ESTIMATED COSTS BY ASSESSING ALL CASES INVOLVING ADULTS UNDERGOING ROBOTIC SURGERY AT A SINGLE INSTITUTION AND AN EQUAL NUMBER OF PATIENTS UNDERGOING NONROBOTIC SURGERY, MATCHED BY DEMOGRAPHIC AND CLINICAL CHARACTERISTICS. WE ADOPTED A WILLINGNESS TO PAY OF $50 000/QUALITY-ADJUSTED LIFE YEAR (QALY). UNCERTAINTY WAS ADDRESSED BY DETERMINISTIC AND PROBABILISTIC SENSITIVITY ANALYSES. COSTS WERE ESTIMATED BASED ON A TOTAL OF 76 PATIENTS, INCLUDING 38 UNDERGOING ROBOT-ASSISTED AND 38 MATCHED PATIENTS UNDERGOING NONROBOTIC MIS-TLIF. USING POINT ESTIMATES, ROBOTIC SURGERY WAS PROJECTED TO COST $21 546.80 AND TO BE ASSOCIATED WITH 0.68 QALY, AND NONROBOTIC SURGERY WAS PROJECTED TO COST $22 398.98 AND TO BE ASSOCIATED WITH 0.67 QALY. ROBOTIC SURGERY WAS FOUND TO BE MORE COST-EFFECTIVE STRATEGY, WITH COST-EFFECTIVENESS BEING SENSITIVE OPERATING ROOM/MATERIALS AND ROOM COSTS. PROBABILISTIC SENSITIVITY ANALYSIS IDENTIFIED ROBOTIC SURGERY AS COST-EFFECTIVE IN 63% OF SIMULATIONS. OUR RESULTS SUGGEST THAT AT A WILLINGNESS TO PAY OF $50 000/QALY, ROBOTIC ASSISTED MIS-TLIF WAS COST -EFFECTIVE IN 63% OF SIMULATIONS. COST-EFFECTIVENESS DEPENDS ON OPERATING ROOM AND ROOM (ADMISSION) COSTS, WITH POTENTIALLY DIFFERENT RESULTS UNDER DISTINCT NEUROSURGICAL PRACTICES. REPORTED EVENTS: 1. ONE PATIENT UNDERGOING SPINAL SURGERY USING THE GUIDANCE SYSTEM EXPERIENCED INTRAOPERATIVE COMPLICATIONS. THE PATIENT EXPERIENCED A CEREBROSPINAL FLUID LEAK. 2. TWO PATIENTS UNDERGOING SPINAL SURGERY USING THE GUIDANCE SYSTEM EXPERIENCED POST-OPERATIVE INFECTION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "5 SHACHAM STREET", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55432", "manufacturer_contact_exchange": "612", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }