{ "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": "3005075696-2025-00313", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250722", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20250514", "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": "763", "date_added": "20250722", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1428053", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250722", "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": "20250807", "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": "20250722", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "56 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Post Operative Wound Infection", "Insufficient Information", "Post Operative Wound Infection", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20250722", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "22565381", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250702", "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": "375589028", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "PAI, M., SRINIVASA, V., THIRUGNANAM, B., SONI, A., KASHYAP, A., VIDYADHARA, A., RAO, S. K. (2025). ROBOTIC-ASSISTED CERVICAL PEDICLE SCREW FIXATION WITH CUSTOM INSTRUMENTS. CLINICAL SPINE SURGERY. HTTPS://DOI.ORG/10.1097/BSD.0000000000001841 STUDY DESIGN: PROSPECTIVE STUDY OBJECTIVE: THIS STUDY AIMS TO DESCRIBE A WORKFLOW AND CUSTOM INSTRUMENTS FOR ROBOTIC-ASSISTED CERVICAL PEDICLE SCREW PLACEMENT USING THE MAZORX STEALTH EDITION. SUMMARY OF BACKGROUND DATA: POSTERIOR CERVICAL SPINAL INSTRUMENTATION USING PEDICLE SCREWS OFFERS BIOMECHANICAL ADVANTAGES BUT CARRIES RISKS OF INJURY TO THE VERTEBRAL ARTERY AND NERVE ROOTS. FLUOROSCOPIC AND NAVIGATION AIDS EXIST, YET ROBOTIC ASSISTANCE FOR CERVICAL PEDICLE SCREW PLACEMENT LACKS A DEFINED WORKFLOW. WHILE PREVIOUS GENERATIONS OF SPINE ROBOTS HAVE BEEN USED IN PLACING PEDICLE SCREWS, THERE ARE NO PAPERS IN LITERATURE THAT DESCRIBED THE USE OF THIRD-GENERATION SPINE ROBOTS IN PLACING THEM. METHODS: TWENTY-TWO PATIENTS UNDERGOING CERVICAL PEDICLE SCREW PLACEMENT WITH CUSTOM INSTRUMENTS AND ROBOTIC ASSISTANCE WERE INCLUDED. SCREW TRAJECTORIES WERE PLANNED AND EXECUTED BY THE ROBOTIC ARM, WITH POSTOPERATIVE O-ARM SCANS ASSESSING ACCURACY. CLINICAL AND RADIOLOGIC OUTCOMES AT 3-MONTH FOLLOW-UP WERE MEASURED. RESULTS: A TOTAL OF 206 SCREWS WERE PLACED WITH A 98.1% ACCURACY RATE. FOUR SCREWS BREACHED THE PEDICLE WITHOUT RESULTING IN NERVE ROOT INJURY. AVERAGE SURGICAL TIME WAS 190 MINUTES, WITH 6 MINUTES PER SCREW INSERTION. BLOOD LOSS AVERAGED 180 ML. NDI SCORES IMPROVED FROM 42.3 TO 28.2. COMPLICATIONS INCLUDED SUPERFICIAL WOUND INFECTIONS IN 2 PATIENTS, DEEP WOUND INFECTION IN 1, AND 1 NONDOMINANT VERTEBRAL ARTERY INJURY. CONCLUSIONS: ROBOTIC-ASSISTED CERVICAL PEDICLE SCREW PLACEMENT DEMONSTRATES HIGH ACCURACY AND SIGNIFICANT CLINICAL IMPROVEMENTS, VALIDATING THE WORKFLOW AND CUSTOM INSTRUMENTS DEVELOPED. REPORTED EVENT: TWENTY-TWO PATIENTS UNDERWENT CERVICAL PEDICLE SCREW PLACEMENTTO ADDRESS CERVICAL MYELOPATHY, MYELORADICULOPATHY, OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT, AND/OR DEGENERATIVE CERVICAL SPONDYLOSIS. FOUR SCREWS WERE FOUND TO HAVE BREACHED THE PEDICLE. TWO BREACHES WERE LATERAL, ONE WAS INFERIOR, AND ONE WAS SUPERIOR. ONE SCREW WAS REMOVED FOLLOWING THE LATERAL BREACH. TWO PATIENTS EXPERIENCED SUPERFICIAL WOUND INFECTIONS THAT WERE MANAGED WITH DRESSINGS AND ANTIBIOTICS. ONE PATIENT DEVELOPED A DEEP WOUND INFECTION THAT REQUIRED WOULD EXPLORATION AND LAVAGE. ONE PATIENT SUFFERED A NONDOMINANT VERTEBRAL ARTERY INJURY, WHICH WAS RESOLVED BY INTRAOPERATIVELY TAMPING OF THE SCREW HOLE WITH BONE WAX. THIS PATIENT DID NOT HAVE ANY NEUROLOGICAL SEQUELAE. SEE ATTACHED LITERATURE ARTICLE." }, { "mdr_text_key": "375589029", "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 ACCEPTED 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. E2115 - INFECTIONS E2401 - ARTERY INJURY 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": "" } ] }