{ "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": "3005075696-2022-00062", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220830", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20220803", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55432", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "6122713209", "noe_summarized": "1", "manufacturer_contact_l_name": "BELMER", "source_type": [ "Foreign", "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": "20220830", "manufacturer_contact_f_name": "GLEN", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "134610", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220830", "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": "", "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": "20250801", "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": "20220830", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Pain" ] } ], "distributor_city": "", "date_report": "20220830", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MINNEAPOLIS", "mdr_report_key": "15324531", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220804", "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": "298948181", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ABSTRACT: ROBOTIC ASSISTED SURGERY IS CONTINUOUSLY GETTING MORE COMMON IN SPINAL SURGERY. MANY STUDIES HAVE ALREADY SHOWN AN IMPROVEMENT IN THE ACCURACY OF PEDICLE SCREW PLACEMENT AND A DECREASE OF SURGICAL REVISIONS. UP TO NOW ONLY A FEW STUDIES EXIST REGARDING THE LEARNING CURVE AND THE TIME NEEDED FOR ROBOTIC ASSISTED SPINAL FUSIONS. FOR GERMANY NO RELEVANT DATA ARE AVAILABLE SO FAR. THIS PROSPECTIVE AND COMPARATIVE STUDY FOCUSSED ON THE LEARNING CURVE COMPARED TO THE STANDARD SURGICAL PROCEDURE. MATERIAL AND METHODS: SINGLE-CENTER PROSPECTIVE DATA COLLECTION OF ALL PERFORMED SPINAL FUSIONS, WHETHER STANDARD OPEN (SO) OR ROBOTIC ASSISTED (RAS), OVER A PERIOD OF 5 MONTHS. EVALUATION OF TIME NEEDED FOR ROBOTIC REGISTRATION AND PEDICLE SCREW PLACEMENT, AMOUNT OF BLOOD LOSS, X-RAY DOSE, AND COMPLICATIONS. LEARNING CURVE WAS CALCULATED USING CURVE FITTING REGRESSION MODELS IN SPSS. RESULTS: 71 NON-RANDOMIZED PATIENTS WERE INCLUDED OF WHOM 42 (MEAN AGE 64 ± 15 YEARS) UNDERWENT ROBOTIC ASSISTED SURGERY (RAS) (MAZOR X STEALTH STATION, MEDTRONIC), 29 (MEAN AGE 63 ± 19 YEARS, P = 0.761) UNDERWENT STANDARD OPEN SURGERY (SO). THE AVERAGE NUMBER OF IMPLANTED SCREWS FOR SO WAS 6 ± 3, AND FOR RAS 8 ± 4(P = 0.028). NO DIFFERENCES IN BLOOD LOSS (ML) PER SCREW SO 117 ± 54, RAS 99 ± 63 (P = 0.234) COULD BE FOUND. X-RAY DOSE (CGYM2) PER SCREW WAS FOR SO WITH 214 ± 135 HIGHER AS FOR RAS 114 ± 165 (P = 0.010). TIME FOR PEDICLE SCREW PLACEMENT PER SCREW (MIN) DID NOT DIFFER: SO 8 ± 5, RAS 9 ± 4.TIME OF ROBOTIC REGISTRATION: 26 ± 13 MIN. SPECIFIC COMPLICATIONS FOR ROBOTIC SURGERY WERE ALL TECHNICAL DIFFICULTIES AND OCCURRED IN 21% (N = 9): ONE LOSS OF X-RAY CAPABILITY, ONE INABILITY TO PLAN A PEDICLE SCREW FOR L5 DUE TO CT ISSUES, ONE COLLISION OF THE ROBOTIC ARM WITH THE FIXATION CLAMP AT T9, ONE NECESSITY FOR A DOUBLE REGISTRATION, INSUFFICIENT PLANNING OF ILIUM SCREW, ONE NECESSITY FOR A DOUBLE CT SCAN, POSTOPERATIVE REASSESSMENT BECAUSE OF PELVIC PAIN FOLLOWING A PIN BREAKOUT INTRAOPERATIVELY, AND INABILITY OF ROBOTIC TO IDENTIFY S1 AND S2.THE LEARNING CURVE SHOWED SIGNIFICANT REDUCTION IN THE TOTAL TIME OF ROBOTIC REGISTRATION (P = 0.007). DISCUSSION: DURING THE 5-MONTH PERIOD USING RAS, THE LEARNING CURVE SHOWED REDUCTION TIME NEEDED FOR ROBOTIC REGISTRATION AND REDUCED X-RAY DOSE. THE BLOOD LOSS AND THE TIME REQUIRED FOR SCREW PLACEMENT SEEMS VERY COMPARABLE. NEVERTHELESS, THE TIME REQUIRED FOR PATIENT POSITIONING AND INCISION-SUTURE TIME ARE STILL SLIGHTLY LONGER WITH RAS, COMPARED TO THE STANDARD OPEN PROCEDURE. THE HIGHER THE NUMBER OF INSERTED SCREWS THE LOWER THE TIME DIFFERENCE GETS. DURING THE LEARNING PERIOD SUBSTANTIAL TIME DEVIATIONS AS WELL AS TECHNICAL COMPLICATIONS MUST BE EXPECTED. REPORTED EVENT: POSTOPERATIVE REASSESSMENT BECAUSE OF PELVIC PAIN FOLLOWING A PIN BREAKOUT INTRAOPERATIVELY." }, { "mdr_text_key": "298948182", "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 ABSTRACT FROM AN ORAL PRESENTATION: ULRICH J., SCHENK P., RAPPERT D., ACHIM G., JONAS S., OLEKSANDR Z., DIRK R., SCHNAKE K. INTRODUCING A ROBOTIC-ASSISTED SYSTEM IN A SPINE SURGERY DIVISION-A PROSPECTIVE COMPARATIVE EVALUATION. GLOBAL SPINE JOURNAL, 2022 12:3 (70S-71S). MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." } ], "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": "" } ] }