{ "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": "3005075696-2025-00347", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250924", "manufacturer_address_2": "", "pma_pmn_number": "K230064", "date_of_event": "20250810", "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": "IT", "manufacturer_contact_area_code": "763", "date_added": "20250924", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1484078", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250924", "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": [ "Incorrect, Inadequate or Imprecise Result or Readings", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20251021", "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": "20250924", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "60 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Unspecified Infection", "Spinal deformity", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Infection", "Spinal deformity" ] } ], "distributor_city": "", "date_report": "20250924", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "23136118", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250902", "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": "380935281", "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 NOT PROVIDED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS PUBLISHED ONLINE 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. H.6. MULTIPLE PATIENT CODES WERE APPLIED. BELOW LISTED WHAT EACH CORRELATES TO. E0506 - BLOOD LOSS E1906 - INFECTION E1642 - JUNCTIONAL SYNDROME 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": "380935282", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IACCARINO, F., DUGONI, D. E., PAVESI, G., LANDI, A., GALLIENI, M., GIORDANO, M., IACCARINO, C. (2025). ROBOTIC SPINE SURGERY COMPARED WITH FLUOROSCOPIC-ASSISTED SURGERY: ADVANTAGES, DISADVANTAGES, FUTURE PERSPECTIVES. JOURNAL OF ROBOTIC SURGERY, 19(1). HTT PS://DOI.ORG/10.1007/S11701-025-02654-1 SUMMARY: BACKGROUND: ROBOTIC SPINE SURGERY (RSS) COULD POTENTIALLY OVERCOME SOME LIMITATIONS OF FLUOROSCOPIC-ASSISTED SURGERY (FAS). THE AIM OF THIS STUDY WAS TO ANALYZE RSS ADVANTAGES COMPARED TO FAS AND THE IMPACT OF A DEDICATED NURSING TEAM ON SURGICAL WORKFLOW EFFICIENCY. MATERIALS AND METHODS: WE RETROSPECTIVELY ANALYZED 260 ADULT PATIENTS WITH THORACOLUMBAR DEGENERATIVE/TRAUMATIC INSTABILITY. ONE-HUN DRED-THIRTY UNDERWENT POSTERIOR FUSION WITH MEDTRONIC MAZOR X, WHILE 130 WERE TREATED WITH FAS. PARAMETERS INCLUDED OPERATIVE DURATION, OR ENTRY-TO-START TIME, SCREW IMPLANTATION TIME, ACCURACY (GERTZBEIN-ROBBINS CLASSIFICATION), RADIATION EXPOSURE, COMPLICATIONS, AND OSWESTRY DISABILITY INDEX (ODI). WE ALSO ASSESSED OR ENTRY-START SURGERY/IMPLANT TIMES, NUMBER OF SCREWS IMPLANTED, AND DURATION OF THE INTERVENTION BEFORE AND AFTER THE INTRODUCTION OF A DEDICATED NURSING TEAM FOR RSS. RESULTS: RSS REDUCED IMPLANTATION TIMES WITH HIGHER ACCURACY OF PEDICLE SCREWS. IT DECREASED EXPOSURE TO RADIATION FOR BOTH SURGEONS AND PATIENTS. IN OUR CASE SERIES, THERE WERE NO SIGNIFICANT DIFFERENCES IN COMPLICATIONS OR HOSPITALIZATION TIMES. A 10% DIFFERENCE IN MEANS WAS OBSERVED TO THE MOST RECENT FOLLOW-UP BETWEEN ODI OF THE PATIENTS OPERATED WITH ROBOTIC (5%) AND FLUOROSCOPIC ASSISTED (15%) SURGERY. IN THE RSS GROUP, THREE (2.3%) CASES OF JUNCTIONAL SYNDROME OCCURRED, SEVENTEEN (13.1%) WITH FAS. IMPLEMENTING A DEDICATED NURSING TEAM REDUCED OR ENTRY-START TIME AND OVERALL DURATION OF ROBOTIC PROCEDURES. CONCLUSIONS: IN OUR EXPERIENCE, RSS HAD IMPORTANT ADVANTAGES COMPARED TO FAS IN TERMS OF ACCURACY OF PEDICLE SCREW POSITIONING. IT REDUCED IMPLANTATION TIMES AND POSTOPERATIVE PAIN WITHOUT ADDITIONAL COMPLICATIONS. THE LEARNING CURVE OF THE OPERATING ROOM STAFF RE PRESENTED A CRUCIAL POINT IN THE SPEED OF EXECUTION OF THE PROCEDURE. REPORTED EVENTS: ONE HUNDRED THIRTY PATIENTS UNDERWENT POSTERIOR FUSION TO ADDRESS DEGENERATIVE OR TRAUMATIC INSTABILITY OF THE THORACOLUMBAR SPINE. SEVEN HUNDRED FIFTY-SEVEN SCREWS WERE PLACED, WHERE TWO PERCENT BREACHED THE PEDICLE CORTEX BY LESS THAN TWO MILLIMETERS. IT WAS ALSO NOTED THAT THERE WERE FOUR REVISIONS, ELEVEN PATIENTSUNDERWENT A TRANSFUSION DUE TO LARGE BLOOD LOSSES, THERE WERE FOUR INFECTIONS, AND THREE CASES OF JUNCTIONAL SYNDROME. NO ADVERSE EVENTS WERE RELATED TO THE GUIDANCE SYSTEM." } ], "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": "" } ] }