{ "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": "7000 CENTRAL AVENUE NE RCW215", "manufacturer_g1_city": "CAESAREA HEFA,IL", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "61227132", "event_type": "Injury", "report_number": "3005075696-2024-00071", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240628", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20240429", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "612", "date_added": "20240628", "manufacturer_contact_f_name": "GLEN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "816266", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240628", "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": "SC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250820", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "30", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6122", "patient": [ { "patient_sequence_number": "1", "date_received": "20240628", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "60 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Neuropathy", "Thrombosis/Thrombus", "Neuropathy", "Thrombosis/Thrombus" ] } ], "distributor_city": "", "date_report": "20240628", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MINNEAPOLIS", "mdr_report_key": "19636872", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240624", "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": "345878219", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "PATIENT INFORMATION WAS INCLUDED IN THE JOURNAL. A.2. THIS VALUE IS THE MEDIAN AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THE PATIENT'S WEIGHT WAS NO PROVIDED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS PUBLISHED AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. INCLUDED THE ARTICLE CITATION D.4. THE SYSTEM SERIAL NUMBER WAS NOT PROVIDED IN THE JOURNAL ARTICLE. NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. DEVICE MANUFACTURING DATE WAS UNAVAILABLE. MULTIPLE PATIENT CODES WERE APPLIED. BELOW LISTED WHAT EACH CORRELATES TO. E0514 - DEEP VEIN THROMBOSIS E0126 - RADICULITIS, RADICULOPATHY 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": "345878220", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "CITATION: HTTPS://DOI.ORG/10.1016/J.WNSX.2024.100390 SUMMARY: BACKGROUND: ROBOTIC-ASSISTED, ENDOSCOPIC TRANSFORAMINAL LUMBAR INTERBODY FUSION (RE-TLIF) IS A PROMISING, MINIMALLY INVASIVE SURGICAL OPTION FOR DEGENERATIVE LUMBAR SPONDYLOSIS/SPONDYLOLISTHESIS; HOWEVER, OUTCOMES DATA AND EFFICACY ARE LIMITED, ESPECIALLY IN MULTILEVEL DISEASE. HERE, WE PRESENT THE FIRST REPORTED SERIES OF PATIENTS THAT UNDERWENT EITHER SINGLE OR MULTILEVEL RE-TLIF. METHODS: A RETROSPECTIVE REVIEW WAS PERFORMED ON 23 CONSECUTIVE PATIENTS WHO UNDERWENT A SINGLE LEVEL OR MULTILEVEL RE-TLIF BY A SINGLE SURGEON. VARIABLES INCLUDED DEMOGRAPHICS, PERIOPERATIVE RESULTS, PAIN SCORES, AND FUNCTIONAL OUTCOME SCORES. RESULTS: EIGHTEEN PATIENTS (78.3 %) UNDERWENT SINGLE LEVEL RE-TLIF AND 5 PATIENTS (21.7 %) UNDERWENT MULTILEVEL RE-TLIF. THE MEDIAN REDUCTION OF VISUAL ANALOG SCALE (VAS) FOR LOW BACK PAIN (LBP) OF ALL SUBJECTS WAS 6 (IQR = 4.5, 6.5) WITH NO SIGNIFICANT DIFFERENCE BETWEEN SINGLE LEVEL AND MULTILEVEL RE-TLIF (P = 0.565). THE MEDIAN REDUCTION OF VAS FOR LEG PAIN OF ALL SUBJECTS 7 (IQR = 6, 8) WITH NO SIGNIFICANT DIFFERENCE BETWEEN SINGLE LEVEL AND MULTILEVEL RE-TLIF (P = 0.702). MEDIAN BLOOD LOSS WAS 25 CC (IQR = 25, 25) AND 50 CC (IQR = 25, 100) FOR SINGLE AND MULTILEVEL RE-TLIF, RESPECTIVELY (P = 0.025), WHEREAS MEDIAN LENGTH OF STAY WAS 1 (IQR = 1, 1; MEAN = 1.0 ± 00.18) DAYS AND 1 (IQR = 1, 2; MEAN = 1.4 ± 00.54) DAYS, RESPECTIVELY (P = 0.042). ONE MAJOR COMPLICATION WAS OBSERVED REQUIRING REOPERATION FOR DEMINERALIZED BONE MATRIX MIGRATION RESULTING IN AN L5 RADICULOPATHY. CONCLUSIONS: SINGLE AND MULTI-LEVEL RE-TLIF APPEARS TO BE A SAFE AND EFFICACIOUS APPROACH WITH COMPARABLE OUTCOMES TO OPEN AND OTHER MINIMALLY INVASIVE APPROACHES. ADDITIONALLY, WE OBSERVED FAVORABLE ACCURACY IN ROBOT-ASSISTED PEDICLE SCREW, ENDOSCOPE, AND INTERBODY DEVICE PLACEMENT. REPORTED EVENTS: THIS STUDY OBSERVED 23 PATIENTS, 11 MALE AND 12 FEMALE. THE MEDIAN AGE WAS 60 YEARS. THERE WERE 4 INSTANCES OF POST-OPERATIVE RADICULITIS THAT IMPROVED BY 1 MONTH FOLLOW UP. ONE PATIENT HAD A LOWER EXTREMITY DEEP VEIN THROMBOSIS AT POST-OPERATIVE DAY 10. THERE WAS ONE RE-OPERATION REQUIRED DUE TO MIGRATION OF DEMINERALIZED BONE MATRIX (DBM) CAUSING RADICULOPATHY. THIS WAS TREATED BY PERCUTANEOUS ENDOSCOPIC WASHOUT OF THE DBM." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "1 HAESHEL STREET. (BUILDING C)", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55432", "manufacturer_contact_exchange": "612", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }