{ "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": "3005075696-2026-00070", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20260304", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20260130", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55112", "reporter_occupation_code": "PHYSICIAN ASSISTANT", "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": "", "date_added": "20260304", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "573285", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260304", "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", "Use of Device Problem" ], "reporter_state_code": "VA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260327", "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": "20260304", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "60 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Dural Tear", "Anemia", "Cerebrospinal Fluid Leakage", "Hematoma", "Pain", "Pneumothorax", "Stenosis", "Post Operative Wound Infection", "Unspecified Nervous System Problem", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20260304", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "24507888", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260209", "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": "394669550", "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 MEDIAN 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 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. E1 - STREET 1 - 11800 SUNRISE VALLEY DR STE 600 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. E0144 - DUROTOMY E2401 - DECREASE MOTOR SIGNAL, VASCULAR INJURY, PROXIMAL JOINT KYPHOSIS, ADJACENT SEGMENT DISEASE, PSEUDOARTHROSIS E0734 - PNEUMOTHORAX E2115 - WOUND INFECTION E0139 - NEUROLOGIC DEFICIT E0505 - HEMATOMA E2337 - STENOSIS E0106 - PSEUDOMENINGOCELE E0301 - ACUTE BLOOD LOSS ANEMIA E2330 - LEG PAIN WITHOUT NEUROLOGIC DEFICIT 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": "394669551", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "OROSZ, L. D., POULTER, G. T., HAINES, C. M., LEE, N. J., RAFIQZAD, Y., LEREBO, W. T., ROY, R. T., JAZINI, E., GUM, J. L., LEHMAN, R. A., GOOD, C. R. (2026). COMPREHENSIVE OUTCOMES FOLLOWING NAVIGATED ROBOTICS IN THORACOLUMBAR SPINE SURGERY: THE PROGRSS FINAL ANALYSIS. GLOBAL SPINE JOURNAL. HTTPS://DOI.ORG/10.1177/21925682261421190 SUMMARY STUDY DESIGN: PROSPECTIVE MULTICENTER COHORT STUDY. OBJECTIVES: INTEGRATION OF ROBOTIC GUIDANCE WITH NAVIGATION REPRESENTS A NATURAL EVOLUTION IN SPINE SURGERY TECHNOLOGIES. BOTH MODALITIES HAVE INDEPENDENTLY DEMONSTRATED IMPROVED IMPLANT ACCURACY, REDUCED RADIATION EXPOSURE, AND EXPANDED MINIMALLY INVASIVE CAPABILITIES, YET DATA ON INTEGRATED PLATFORMS REMAIN LIMITED. THE PROSPECTIVE ROBOTIC-GUIDED REGISTRY OF SPINE SURGERY (PROGRSS) EVALUATES SURGICAL, CLINICAL, AND PATIENT-REPORTED OUTCOMES ACROSS A BROAD RANGE OF PROCEDURES PERFORMED WITH AN INTEGRATED ROBOTIC-ASSISTED NAVIGATION SYSTEM. METHODS: ADULTS UNDERGOING NAVIGATED ROBOTIC THORACOLUMBAR SURGERY BETWEEN 2020 AND 2024 WERE ENROLLED BY SIX SURGEONS ACROSS FOUR CENTERS. DEMOGRAPHIC, SURGICAL, AND ROBOT-RELATED METRICS WERE COLLECTED. PATIENT-REPORTED OUTCOMES INCLUDED ODI AND PROMIS GLOBAL HEALTH, PHYSICAL FUNCTION, AND PAIN INTERFERENCE. COMPLICATIONS, REVISION SURGERY, INPATIENT RESOURCE UTILIZATION, AND RETURN-TO-WORK METRICS WERE ANALYZED. RESULTS: OF 657 ENROLLED PATIENTS, 606 COMPLETED 12-MONTH FOLLOW-UP (92%). MEDIAN AGE WAS 60 YEARS; 49.9% WERE FEMALE. OF 5166 PLANNED SCREWS, 99.2% WERE PLACED, WITH 98.4% ACCURATELY POSITIONED AND 1.5% MALPOSITIONED. ROBOT ABANDONMENT OCCURRED IN 0.6% OF CASES. ROBOT-RELATED INTRAOPERATIVE OR POSTOPERATIVE ADVERSE EVENTS OCCURRED IN 0.3% OF CASES. TWELVE MONTH REVISION SURGERY RATE WAS 4.8%, INCLUDING 0.3% ROBOT-RELATED REVISIONS. RESOURCE UTILIZATION WAS LOW: 5.2% REQUIRED TRANSFUSION, 2.1% POSTOPERATIVE CT, MEDIAN LENGTH OF STAY WAS 3 DAYS, AND 88.4% WERE DISCHARGED HOME. PATIENTS DEMONSTRATED SIGNIFICANT, CLINICALLY MEANINGFUL IMPROVEMENT ACROSS ALL PRO DOMAINS. CONCLUSIONS: THIS LARGE PROSPECTIVE EVALUATION OF AN INTEGRATED NAVIGATION¿ROBOTIC PLATFORM DEMONSTRATES HIGH ACCURACY, LOW COMPLICATION AND REVISION RATES, EFFICIENT RESOURCE USE, AND SUBSTANTIAL PATIENT-REPORTED OUTCOME IMPROVEMENT, ESTABLISHING A CONTEMPORARY B ENCHMARK FOR NAVIGATED ROBOTIC SPINE SURGERY. REPORTED EVENT SIX HUNDRED EIGHTY-EIGHT PATIENTS COMPLETED THE PREOPERATIVE VISIT TO UNDERGO ROBOTIC GUIDED SPINAL SURGERY. SIX HUNDRED FIFTY SEVEN ENDED UP UNDERGOING THE PROCEDURE. OF THE PATIENTS THAT UNDERWENT THE PROCEDURE, THERE WERE SEVENTY FIVE SCREWS THAT WERE MALPOSITIONED AND THERE WERE FORTY NINE REGISTRATION ISSUES. THE SYSTEM GUIDANCE SYSTEM WAS ABORTED IN FOUR CASES DUE TO THE REGISTRATION ISSUES. SEVENTY FIVE SCREWS WERE REVISED, REPLACED, OR REMOVED. TWO ADVERSE EVENTS WERE FOUND TO BE RELATED TO THE GUIDANCE SYSTEM. ONE WAS A DUROTOMY AND THE OTHER WAS AN IMPLANT RELATED TRANSIENT DECREASE IN MOTOR SIGNALS. THERE WERE ALSO TWO SURGICAL COMPLICATIONS RELATED TO SCREW MALPOSITION RELATED TO THE GUIDANCE SYSTEM. THERE WERE A TOTAL OF A HUNDRED AND SIXTY-TWO ADVERSE EVENTS THAT WERE NOT RELATED TO THE GUIDANCE SYSTEM. TWENTY-ONE OCCURRED INTRA-OP, WHICH CONSISTED OF FIFTEEN DUROTOMY, THREE VASCULAR INJURY, TWO MOTOR SIGNAL LOSS, AND ONE PNEUMOTHORAX. THE REST OF THE ADVERSE EVENTS OCCURRED POST-OP, AND CONSISTED OF FOURTEEN WOUND INFECTI ONS, SIXTEEN IMPLANT FAILURES, SEVENTEEN NEUROLOGIC DEFICIT, SEVEN HEMATOMA, SEVEN PSEUDOMENINGOCELE, TWO TRAUMA AFFECTING CONSTRUCTS, THIRTY EIGHT ACUTE BLOOD LOSS ANEMIA, AND TWENTY OTHER ISSUES THAT CONSISTED OF PROXIMAL JUNCTIONAL KYPHOSIS OR FAILURE, ADJACENT SEGMENT DISEASE, PSEUDOARTHROSIS, LEG PAIN WITHOUT NEUROLOGIC DEFICIT, AND STENOSIS. FIVE REVISIONS OCCURRED DURING THE INDEX HOSPIT ALIZATION DUE TO SUBSIDENCE, CAGE REPOSITIONING, OR HEMATOMA EVACUATION. THREE REVISIONS OCCURRED DURING THE FIRST POST-OP VISIT FOR WOUND INCISION AND DRAINAGE OR SEROMA EVACUATION. SIX REVISIONS OCCURRED AT NINETY DAYS DUE TO SUBSIDENCE, DECOMPRESSION, WOULD INCISION AND DRAINAGE, OR EXTENSION OF FUSION. FIFTEEN REVISIONS OCCURRED BETWEEN NINETY DAYS AND TWELVE MONTHS DUE TO DECOMPRESSION, EXTENSION OF FUSION, CORONAL ALIGNMENT ADJUSTMENT, INSTRUMENTATION REMOVAL, AND REVISION FUSION. FINALLY, TWO REVISION PROCEDURES FOR HARDWARE REMOVAL WERE ATTRIBUTED TO ROBOTIC FACTORS. ALSO, IT WAS NOTED THAT THIRTY-FOUR PATIENTS UNDERWENT BLOOD TRANSFUSIONS POST-OP. SEE ATTACHED LITERATURE ARTICLE." } ], "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": "" } ] }