{ "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": "3005075696-2026-00091", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260501", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20260111", "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": "IN", "manufacturer_contact_area_code": "", "date_added": "20260501", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1115586", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260501", "brand_name": "UNKNOWN MAZOR 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": "TPL0059-01", "catalog_number": "TPL0059-01", "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" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260710", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "30", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260501", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "58 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20260501", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "25056665", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260407", "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": "400070701", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "G2: THIS EVENT OCCURRED IN INDIA, SEE SECTION E. H3, H6: NO PRODUCTS WERE RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. 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": "400070702", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "CITATION: HTTPS://DOI.ORG/10.1016/J.JOR.2026.01.009 SUMMARY: OBJECTIVES: TO EVALUATE THE CLINICAL, IMAGING, AND PERI-OPERATIVE RESULTS OF ROBOTIC-GUIDED CONVENTIONAL VERSUS ROBOT ASSISTED MINIMALLY INVASIVE TECHNIQUES FOR S2 ALAR-ILIAC (S2AI) SCREW PLACEMENTDURING SPINOPELVIC FIXATION. METHODS: A PROSPECTIVE COMPARATIVE STUDY COMPARING THE CLINICORADIOLOGICAL PARAMETERS OF PATIENTS UNDERGOING CONVENTIONAL ROBOTIC ASSISTED S2AI SCREW INSERTION AND THOSE WHO UNDERWENT ROBOTIC MINIMALLY INVASIVE PERCUTANEOUS SCREW INSERTION BETWEEN NOVEMBER 2023 AN D JUNE 2025 WAS DONE. DATA COLLECTED INCLUDED DEMOGRAPHICS, OPERATIVE TIME, INTRAOPERATIVE BLOOD LOSS, POSTOPERATIVE PAIN, HOSPITAL STAY, RADIOGRAPHIC ANGLES, RADIATION DOSE, SCREW ACCURACY, AND COMPLICATIONS. RESULTS: A TOTAL OF 102 PATIENTS UNDERWENT SPINOPELVIC FIXATION DURING THE STUDY PERIOD - 56 PATIENTS (116 SCREWS) UNDERWENT CONVENTIONAL ROBOTIC ASSISTED S2AI SCREW INSERTION AND 46 PATIENTS (92 SCREWS) UNDERWENT ROBOT ASSISTED PERCUTANEOUS S2AI SCREW INSERTION. BOTH GROUPS SHOWED ACCURATE SCREW PLACEMENT WITHOUT ANY INTRAOPERATIVE ADVERSE EVENTS. THE ROBOT ASSISTED PERCUTANEOUS GROUP HAD MARKEDLY REDUCED POSTOPERATIVE VAS SCORES (3.2 ± 1.1 VS. 5.8 ± 1.5, P < 0.0001) AND REDUCED LENGTH OF STAY (3.1 ± 0.9 VS. 5.0 ± 1.3 DAYS, P < 0.0001). INTRAOPERATIVE BLOOD LOSS, WOUND COMPLICATIONS AND OPERATIVE TIME WERE ALSO LESSER IN THE ROBOT ASSISTED GROUP BUT WAS NOT STATISTICALLY SIGNIFICANT. ALL OTHER RADIOGRAPHIC PARAMETERS AND RADIATION DOSE WERE COMPARABLE ACROSS GROUPS. CONCLUSION: ROBOT ASSISTED MINIMALLY INVASIVE S2AI SCREW PLACEMENT IS A SAFE AND EFFICIENT ALTERNATIVE TO THE CONVENTIONAL OPEN TECHNIQUE. IT OFFERS COMPARABLE RADIOGRAPHIC ACCURACY AND BIOMECHANICAL STABILITY, WITH THE ADDED BENEFITS OF REDUCED POSTOPERATIVE PAIN AND SHORTER HOSPITAL STAY. REPORTED EVENT(S): THIS ARTICLE REVIEWED THE CASES OF 102 PATIENTS. THE MEAN AGE WAS 57.9 ± 14.6 YEARS IN THE CONVENTIONAL GROUP AND 61.6 ± 12.0 YEARS IN THE MINIMALLY INVASIVE GROUP. THERE WAS A HIGHER PERCENTAGE OF WOMEN PRESENT IN THE CONVENTIONAL COHORT (71.4 %) COMPARED WITH THE MINIMALLY INVASIVE GROUP (43.5 %). MINOR WOUND ISSUES (SUPERFICIAL GAPING WITH MILD DISCHARGE) WERE OBSERVED IN TWO PATIENTS IN THE CONVENTIONAL GROUP AND ONE PATIENT IN THE MINIMALLY INVASIVE GROUP. ALL RESOLVED WITH LOCAL WOUND CARE AND AN EXTENDED ANTIBIOTIC REGIMEN." } ], "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": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }