{ "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": "3005075696-2025-00246", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250410", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20250214", "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": [ "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20250410", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "350054", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250410", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250814", "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": "20250410", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "61 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cerebrospinal Fluid Leakage", "Seroma", "Post Operative Wound Infection", "Insufficient Information", "Cerebrospinal Fluid Leakage", "Seroma", "Post Operative Wound Infection", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20250410", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "21815140", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250402", "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": "367895353", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "QUICENO, E., SOLIMAN, M. A., KHAN, A., MULLIN, J. P., POLLINA, J. (2025). HOW DO ROBOTICS AND NAVIGATION FACILITATE MINIMALLY INVASIVE SPINE SURGERY? A CASE SERIES AND NARRATIVE REVIEW. NEUROSURGERY, 96(3S). HTTPS://DOI.ORG/10.1227/NEU.0000000000003352 BACKGROUND AND OBJECTIVE: IMAGE GUIDANCE HAS TRANSFORMED MINIMALLY INVASIVE SPINE SURGERY (MISS), ALLOWING FOR SAFER PROCEDURES WITHOUT EXCESSIVE BONY EXPOSURE AND REDUCING RADIATION EXPOSURE FOR THE SURGICAL TEAM. ROBOTIC PLATFORMS HAVE ENHANCED THE BENEFITS OF NAVIGATION BY PROVIDING HIGH PRECISION AND ACCURACY. HERE WE DESCRIBE A CASE SERIES TO DEMONSTRATE THE ACCURACY AND LOW COMPLICATION RATES OF REAL-TIME IMAGE-GUIDED ROBOTIC-ASSISTED (RA) MISS AT A TERTIARY REFERRAL CENTER. IN ADDITION, WE PERFORMED A NARRATIVE REVIEW ONHOW ROBOTICS AND NAVIGATION FACILITATE MISS. METHODS: A RETROSPECTIVE CHART REVIEW WAS CONDUCTED TO OBTAIN DATA FOR PATIENTS WHO UNDERWENT RA LUMBAR FUSIONS WITH REAL-TIME NAVIGATION FOR DEGENERATIVE LUMBAR PATHOLOGY BETWEEN SEPTEMBER 1, 2021, AND JANUARY 1, 2024. THE MAZOR X STEALTH EDITION (MEDTRONIC) ROBOTIC PLATFORM WAS USED. THE ACCURACY OF SCREW PLACEMENT WAS DETERMINED ACCORDING TO GERTZBEIN-ROBBINS CLASSIFICATION. INTRAOPERATIVE AND POSTOPERATIVE COMPLICATION RATES UP TO 90 DAYS WERE RECORDED. INTRAOPERATIVE VARIABLES AND LENGTH OF STAY WERE COMPARED BETWEEN OPEN AND PERCUTANEOUS GROUPS. RESULTS: A TOTAL OF 247 PATIENTS UNDERWENT INSERTION OF 1156 PEDICLE SCREWS. THE MEAN PATIENT AGE WAS 61.1 ± 11.5 YEARS. THE MEAN TOTAL OPERATIVE TIME WAS 195.1 ± 80.8 MINUTES. THE MEAN OPERATIVE TIME PER SCREW WAS 4.2 ± 1.4 MINUTES, WITH A MEAN OF 4.6 ± 1.4 SCREWS PER CASE. THE MEAN FLUOROSCOPY TIME PER SCREW WAS 6.4 ± 6.2 SECONDS. EIGHTY-FIVE PATIENTS (34.4%) UNDERWENT OPEN RA PEDICLE SCREW PLACEMENT, AND 162 (65.6%) UNDERWENT PERCUTANEOUS RA PEDICLE SCREW PLACEMENT. NO DIFFERENCES IN OPERATIVE TIME, LENGTH OF STAY, FLUOROSCOPY TIME, AND SURGICAL COMPLICATIONS WERE FOUND BETWEEN GROUPS. INTRAOPERATIVELY, 2 PATIENTS (0.8%) EXPERIENCED COMPLICATIONS AND 4 PATIENTS (1.6%) DEVELOPED COMPLICATIONS WITHIN 90 DAYS. SCREW PLACEMENT ACCURACY WAS PERFECT IN 1126 SCREWS (97.4%) AND CLINICALLY ACCEPTABLE IN 30 SCREWS (2.6%). THESE RESULTS WERE CONSISTENT WITH THOSE REPORTED IN THE LITERATURE. CONCLUSION: ROBOTIC PLATFORMS HAVE FURTHER ENHANCED NAVIGATION BENEFITS BY PROVIDING HIGH PRECISION AND ACCURACY, WITH LOW COMPLICATION RATES. REPORTED EVENTS TWO HUNDRED AND FORTY-SEVEN PATIENTS WITH DEGENERATIVE LUMBAR DISEASE UNDERWENT REAL-TIME IMAGE GUIDED ROBOTIC ASSISTED PEDICLE SCREW PLACEMENT. THIRTY SCREWS WERE INACCURATE BY TWO MILLIMETERS OR LESS, BUT ALL WERE FOUND TO BE CLINICALLY ACCEPTABLE. THERE WERE TWO PATIENTS THAT EXPERIENCED A CEREBROSPINAL FLUID(CSF) LEAK. THE CSF LEAK WAS ASSOCIATED WITH THE LAMINECTOMY AND NOT WITH THE SCREW POSITIONING. IT WAS ALSO NOTED THAT FOUR PATIENTS DEVELOPED COMPLICATIONS WITHIN THE FIRST NINETY DAYS. ALL FOUR WERE WOUND RELATED, CONSISTING OF TWO WOUND INFECTIONS REQUIRING RE-OPERATION, ONE SUPERFICIAL DEHISCENCE, AND ONE SEROMA. SEE ATTACHED LITERATURE ARTICLE." }, { "mdr_text_key": "367895354", "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 NO 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. E0106 - CSF LEAK E2115 - WOUND INFECTION E0307 - SEROMA E2401 - DEHISCENCE 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": "" } ] }