{ "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": "3005075696-2025-00232", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250324", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20241008", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55112", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "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": "CH", "manufacturer_contact_area_code": "763", "date_added": "20250324", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2310454", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250324", "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": "20250725", "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": "20250324", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "44 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Vascular Problem", "Unspecified Vascular Problem" ] } ], "distributor_city": "", "date_report": "20250324", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "21678549", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250305", "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": "366506623", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A1-A5) PATIENT INFORMATION WAS INCLUDED IN THE ARTICLE. A2) THIS VALUE REPRESENTS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A3) THIS VALUE REPRESENTS THE MAJORITY SEX OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A4) THE WEIGHT OF THE PATIENTS WAS NOT PROVIDED. A1) PATIENT IDENTIFIER(S) WAS NOT INCLUDED IN THE ARTICLE. B3) PLEASE NOTE THAT THIS DATE IS BASED OFF THE ACCEPTED PUBLICATION DATE OF THE ARTICLE AS SPECIFIC EVENT DATES WERE NOT PROVIDED IN THIS PUBLISHED LITERATURE. B5) INCLUDED THE ARTICLE CITATION. D4) THE SYSTEM SERIAL NUMBER WAS NOT PROVIDED IN THE JOURNAL ARTICLE. H3, H6) NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. H4) DEVICE MANUFACTURING DATE WAS UNAVAILABLE. DIGITAL SHARING OF THE ARTICLE WOULD BE IN VIOLATION OF COPYRIGHT PERMISSION. 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": "366506624", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "CITATION: ZHANG, H., DINGJUN, H., BAORONG, H., HONGHUI, S., ZHENGWEI, X., BIAO, W., YONGCHAO, D., WENLONG, Y., ZILIN, G., CHANGJIANG, K. (2024). COMPARISON OF THE ACCURACY AND SAFETY OF ROBOT-AND NAVIGATION-ASSISTED SCREW PLACEMENT IN ATLANTOAXIAL DISLOCATION SURGERY. NATL MED J CHINA, 104(37), 3506¿3512. HTTPS://DOI.ORG/10.3760/CMA.J.CN112137-20240329-00722 OBJECTIVE: TO COMPARE THE ACCURACY AND SAFETY OF ROBOT-ASSISTED AND NAVIGATION-ASSISTED SCREW PLACEMENT IN ATLANTOAXIAL DISLOCATION SURGERY. METHODS: A RETROSPECTIVE ANALYSIS WAS CONDUCTED ON THE CLINICAL DATA OF 49 PATIENTS WITH ATLANTOAXIAL DISLOCATION TREATED CONSECUTIVELY AT THE HONGHUI HOSPITAL OF XI'AN JIAOTONG UNIVERSITY FROM APRIL 2022 TO DECEMBER 2023. AMONG THEM, 27 WERE MALE AND 22 WERE FEMALE, AGED (44.2±11.7) YEARS. BASED ON THE DATE OF SURGERY, 29 PATIENTS (FROM APRIL 2022 TO APRIL 2023) RECEIVED THE S8 NAVIGATION-ASSISTED SCREW PLACEMENT (NAVIGATION GROUP), 20 PATIENTS (FROM MAY TO DECEMBER 2023) RECEIVED MAZOR ROBOT-ASSISTED SCREW PLACEMENT (ROBOT GROUP). THE ACCURACY OF SCREW PLACEMENT, SCREW PLACEMENT TIME, OPERATION TIME, INTRAOPERATIVE BLOOD LOSS, AND INTRAOPERATIVE COMPLICATIONS WERE RECORDED AND COMPARED BETWEEN THE TWO GROUPS. THE JAPANESE ORTHOPEDIC ASSOCIATION (JOA) SCORE AND VISUAL ANALOG SCALE (VAS) SCORE OF PAIN WERE ADOPTED TO EVALUATE THE RECOVERY OF CERVICAL SPINAL CORD FUNCTION AND CERVICAL AND SHOULDER PAIN AT PREOPERATIVE PERIOD AND 3-MONTH FOLLOW-UP, AND THE OCCURRENCE OF COMPLICATIONS WAS OBSERVED. RESULTS: A TOTAL OF 196 SCREWS WERE INSERTED IN 49 PATIENTS. IN THE NAVIGATION-ASSISTED GROUP, A TOTAL OF 116 SCREWS WERE INSERTED WITH AN ACCURACY RATE OF 93.1% (108/116); IN CONTRAST, IN THE ROBOT-ASSISTED GROUP, A TOTAL OF 80 SCREWS WERE INSERTED WITH AN ACCURACY RATE OF 97.5% (78/80) (P=0.040). THE MEAN SCREW PLACEMENT TIME, OPERATION TIME, AND BLOOD LOSS IN THE NAVIGATION-ASSISTED GROUP WERE ALL SIGNIFICANTLY LOWER THAN THOSE IN THE ROBOT-ASSISTED GROUP [(37.8±3.4) MIN VS (48.4±4.6) MIN, (127.7±15.3) MIN VS (165.7±12.1) MIN AND (205.8±13.6) ML VS (290.6±11.2) ML, RESPECTIVELY ALL P=0.01]. ONE CASE EXPERIENCED INTRAOPERATIVE VENOUS PLEXUS INJURY IN THE ROBOT-ASSISTED GROUP. POSTOPERATIVELY, ALL PATIENTS EXPERIENCED SIGNIFICANT RELIEF IN NECK PAIN SYMPTOMS, AND NEUROLOGICAL SYMPTOMS RECOVERED TO VARYING DEGREES. THE VAS AND JOA SCORES AT 3 MONTHS POST-SURGERY FOR BOTH GROUPS SHOWED STATISTICALLY SIGNIFICANT IMPROVEMENTS COMPARED TO PRE-SURGERY (ALL P=0.01), BUT THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE TWO GROUPS (ALL P>0.05). CONCLUSIONS: BOTH ROBOT-ASSISTED AND NAVIGATION-ASSISTED SCREW PLACEMENT SHOW HIGH ACCURACY AND SAFETY IN ATLANTOAXIAL DISLOCATION SURGERY. COMPARED TO NAVIGATION, ROBOT ASSISTANCE INCREASES THE SURGICAL TIME AND BLOOD LOSS, BUT SIGNIFICANTLY IMPROVES THE ACCURACY OF SCREW PLACEMENT. FUND PROGRAM: SCIENCE AND TECHNOLOGY DEPARTMENT OF SHAANXI PROVINCE KEY INDUSTRIAL INNOVATION CHAIN (GROUP)-SOCIAL DEVELOPMENT PROJECT (2023-ZDLSF-03). REPORTED EVENT(S): 20 PATIENTS (FROM MAY TO DECEMBER 2023) RECEIVED MAZOR ROBOT-ASSISTED SCREW PLACEMENT (ROBOT GROUP). A TOTAL OF 80 SCREWS WERE INSERTED WITH AN ACCURACY RATE OF 97.5% (78/80) (P=0.040) WERE PLACED IN THE ROBOT GROUP. 1 SCREW WAS AT GRADE 1 AND 1 SCREW WAS AT GRADE 2. BASED ON POSTOPERATIVE CT AND THE NEO GRADING STANDARD, GRADE 0 SCREWS ARE ENTIRELY WITHIN THE PEDICLE WITHOUT CORTICAL BREACH, GRADE 1 SCREWS BREACH THE CORTEX BUT 2MM, GRADE 2 SCREWS BREACH THE CORTEX =2MM BUT 4MM, AND GRADE 3 SCREWS BREACH THE CORTEX =4MM. ONE CASE EXPERIENCED INTRAOPERATIVE VENOUS PLEXUS INJURY CAUSED BY THE SLIPPAGE OF THE MECHANICAL ARM DURING SURGERY. THE MEAN BLOOD LOSS IN THE ROBOTIC-ASSISTED GROUP WAS (290.6±11.2) MILLILITERS (ML)." } ], "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": "" } ] }