{ "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": "3005075696-2024-00117", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20240906", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20240618", "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": "20240906", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1343960", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240906", "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": "DA", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/13/2024", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250808", "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": "20240906", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "47 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Urinary Frequency / Polyuria", "Numbness", "Paresthesia", "Pain", "Urinary Frequency / Polyuria", "Numbness", "Paresthesia" ] } ], "distributor_city": "", "date_report": "20241009", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "20162747", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240828", "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": "351239660", "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. 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 ACCEPTED AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. INCLUDED THE ARTICLE CITATION. 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. E1308 - URINARY INCONTINENCE E2330 - RADICULITIS E0127 - NUMBNESS E013403 - TINGLING 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": "351239661", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "GERLING, M., BAKER, M., STANTON, E., PYUN, J., CHALADOFF, E., PASSIAS, P., <(>&<)> BUSER, Z. (2024). CLOSING THE GAP: THE INCIDENCE OF COMPLICATIONS IN MINIMALLY INVASIVE TUBULAR, ENDOSCOPIC, AND ROBOTIC-ASSISTED TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURES. WORLD NEUROSURGERY. HTTPS://DOI.ORG/10.1016/J.WNEU.2024.06.101 SUMMARY: BACKGROUND: THE AIM OF THE CURRENT STUDY WAS TO COMPARE THE INCIDENCE OF POSTOPERATIVE COMPLICATIONS AMONG MINIMALLY INVASIVE SURGERY (MIS) TUBULAR, ENDOSCOPIC, AND ROBOT-ASSISTED TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) TECHNIQUES. METHODS: WE STUDIED CONSECUTIVE PATIENTS WHO UNDERWENT SINGLE-LEVEL OR MULTILEVEL TLIF BETWEEN 2020 AND 2022. PREOPERATIVE AND POSTOPERATIVE PATIENT-REPORTED OUTCOMES (VISUAL ANALOG SCALE LEG SCORE AND OSWESTRY DISABILITY INDEX), DEMOGRAPHIC, AND INTRAOPERATIVE VARIABLES WERE RECORDED. ONE-WAY ANALYSIS OF VARIANCE WITH BARTLETT¿S EQUAL-VARIANCE AND PEARSON CHI-SQUARED TESTS WERE USED. RESULTS: THE STUDY INCLUDED 170 TLIF PATIENTS: 107 (63%) TUBULAR, 42 (25%) ENDOSCOPIC, AND 21 (12%) ROBOT ASSISTED. ALL 3 TLIF TECHNIQUES HAD SIMILAR COMPLICATION RATES: TUBULAR 6 (5.6%), ENDOSCOPIC 2 (4.8%), AND ROBOT ASSISTED 1 (4.8%) ALL OCCURRING WITHIN THE FIRST 2 WEEKS. TUBULAR TLIF REPORTED THE LOWEST INCIDENCE OF NEW-ONSET NEUROLOGIC SYMPTOMS, PRIMARILY RADICULITIS OR NUMBNESS/ TINGLING, AT 2 WEEKS POSTOPERATIVELY (P <(><<)> 0.05) WITH 21 (20%) TUBULAR, 17 (41%) ENDOSCOPIC, AND 9 (43%) ROBOT-ASSISTED PATIENTS. THERE WERE 2 REVISIONS IN THE ROBOT-ASSISTED GROUP, WHILE TUBULAR AND ENDOSCOPIC EACH HAD ONE WITHIN 1 YEAR. THERE WAS NO STATISTICAL DIFFERENCE IN PREOPERATIVE OR POSTOPERATIVE PATIENT-REPORTED OUTCOMES BETWEEN THE TLIF GROUPS. CONCLUSIONS: THE CURRENT STUDY DEMONSTRATED THAT TUBULAR, ENDOSCOPIC, AND ROBOT-ASSISTED TLIF PROCEDURES HAD SIMILAR COMPLICATION RATES. THE TUBULAR MIS TLIF REPORTED FEWER NEW NEUROLOGIC SYMPTOMS COMPARED WITH ENDOSCOPIC AND ROBOT-ASSISTED TLIF PROCEDURES AT 2 WEEKS POSTOPERATIVE, WITH ALL GROUPS DECLINING IN SYMPTOM PERSISTENCY AT LATER TIME INTERVALS. AVERAGE VISUAL ANALOG SCALE SCORES CONTINUOUSLY IMPROVED UP TO 1 YEAR POST OPERATIVELY AMONG ALL GROUPS. REPORTED EVENTS: TWENTY ONE PATIENTS UNDERWENT ROBOTIC ASSISTED TLIF TO ADDRESS LUMBAR DEGENERATIVE DISORDERS. ONE PATIENT EXPERIENCED URINARY INCONTINENCE. AT THE TWO WEEK POST-OPERATIVE APPOINTMENT NINE PATIENTS EXPRESSED TRANSIENT NEW ONSET NEUROLOGICAL SYMPTOMS, PRIMARILY RADICULITIS OR NUMBNESS/TINGLING. ALL NEW NEUROLOGICAL SYMPTOMS RESOLVED AFTER ONE YEAR AFTER THE PROCEDURE. IT WAS DOCUMENTED THAT TWO REVISIONS WERE PERFORMED AMONGST THE ROBOT-ASSISTED GROUP." }, { "mdr_text_key": "353762219", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDENCE AUTHOR REPORTED THAT THE MEDTRONIC GUIDANCE SYSTEM WAS NOT INVOLVED WITH THE PATIENT WITH URINARY INCONTINENCE. ONE CASE, WHERE IT INVOLVED A MEDTRONIC GUIDANCE SYSTEM, THE REVISION OCCURRED FIVE MONTHS LATER." }, { "mdr_text_key": "353762220", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "SEE B5. 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": "10/09/2024" } ] }