{ "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": "3005075696-2025-00113", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250203", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240920", "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": "20250203", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1518098", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250203", "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": "UT", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250825", "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": "20250203", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "64 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Nervous System Problem", "Unspecified Nervous System Problem" ] } ], "distributor_city": "", "date_report": "20250203", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "21293879", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250108", "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": "362721435", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "WANDVIK, CAITLYN, ET AL. ¿LIMITATIONS OF CURRENT ROBOT-ASSISTED PEDICLE SCREW INSERTION SYSTEMS.¿ NEUROSURGICAL FOCUS, VOL. 57, NO. 6, 1 DEC. 2024, HTTPS://DOI.ORG/10.3171/2024.9.FOCUS24545. OBJECTIVE: AS ROBOT SYSTEMS FOR SPINE SURGERY HAVE BEEN DEVELOPED, THEY HAVE DEMONSTRATED A HIGH DEGREE OF ACCURACY IN SCREW PLACEMENT WITHOUT SACRIFICING SAFETY OR SURGICAL EFFICIENCY. THESE ROBOTIC SYSTEMS OFFER PREOPERATIVE PLANNING AND REAL-TIME FEEDBACK TO ENHANCE SURGICAL PRECISION AND MITIGATE HUMAN ERROR. NEVERTHELESS, LIMITATIONS TO THEIR OPTIMAL PERFORMANCE REMAIN. THE AUTHORS ANALYZED THE INITIAL 100 CASES OF PEDICLE SCREW PLACEMENTS PERFORMED USING THE MAZOR X ROBOT AT THEIR INSTITUTION, PRESENTING CASE EXAMPLES TO ILLUSTRATE THE LIMITATIONS THAT WERE EXPERIENCED, AND REVIEWED CURRENT LITERATURE ON THE LIMITATIONS OF ROBOT-ASSISTED SPINE SURGERY, EMPHASIZING THEIR IMPACT ON ACCURACY AND SAFETY. METHODS: THIS WAS A RETROSPECTIVE REVIEW OF THE FIRST 100 CASES OF ROBOT-ASSISTED PEDICLE SCREW PLACEMENT AT THE AUTHORS¿ INSTITUTION BETWEEN DECEMBER 2019 AND JUNE 2024. ALL INTRAOPERATIVE CT SCANS WERE REVIEWED FOR SCREW ACCURACY. MALPOSITIONED SCREWS, NEAR MISSES (SCREW DEVIATION WITHOUT INJURY TO THE PATIENT), OR ABANDONED ROBOT-ASSISTED ATTEMPTS WERE IDENTIFIED, AND THE UNDERLYING REASONS WERE EVALUATED TO DETERMINE THE LIMITATIONS OF CURRENT ROBOT TECHNOLOGY. RESULTS: OF THE FIRST 100 CASES OF ROBOT-ASSISTED PEDICLE SCREW PLACEMENT, THERE WERE 20 SCREW-RELATED COMPLICATIONS, OF WHICH 14 WERE NEAR MISSES, 1 INVOLVED NEUROLOGICAL INJURY CAUSED BY SCREW MALPOSITION, AND 5 WERE CASES IN WHICH A ROBOT-ASSISTED ATTEMPT WAS ABANDONED BEFORE MANUAL SCREW PLACEMENT. THE AUTHORS IDENTIFIED THE FOLLOWING LIMITATIONS WITH CURRENT ROBOT TECHNOLOGY: REGISTRATION ERRORS, SPINE MOVEMENT AFTER REGISTRATION, PATIENT BODY HABITUS, ARTIFACT FROM METALLIC IMPLANTS, POOR BONE DIFFERENTIATION, SKIVING, SOFT-TISSUE INTERFERENCE, AND PHYSICAL CONSTRAINTS. CONCLUSIONS DESPITE THE ADVANCEMENTS OF SPINE ROBOT SYSTEMS, SEVERAL LIMITATIONS PERSIST, ESPECIALLY IN MOBILE OR UNSTABLE SPINE LOCATIONS AND AROUND CRITICAL STRUCTURES. THE AUTHORS¿ EXPERIENCE, WITH PROVIDED CASE EXAMPLES, FURTHER ILLUSTRATES TECHNICAL NUANCES IMPORTANT TO UNDERSTANDING AND NAVIGATING AROUND THESE LIMITATIONS. THE NEED FOR STANDARDIZED REPORTING METRICS TO EVALUATE AND CLASSIFY EMERGING TECHNOLOGIES IS HIGHLIGHTED, EMPHASIZING ONGOING TECHNOLOGICAL INNOVATION TO ENHANCE THE EFFICACY OF ROBOT-ASSISTED SPINE SURGERY. HTTPS://THEJNS.ORG/DOI/ABS/10.3171/2024.9.FOCUS24545 REPORTED EVENT(S): 20 SCREW-RELATED COMPLICATIONS WERE IDENTIFIED. 14 WERE NEAR MISSES (CASES IN WHICH NO INJURY OCCURRED TO PATIENT DESPITE SCREW DEVIATION FROM THE PLANNED TRAJECTORY) AND 1 INVOLVED A NEUROLOGICAL INJURY CAUSED BY SCREW MALPOSITION. 5 WERE CASES IN WHICH A ROBOT-ASSISTED ATTEMPT WAS ABANDONED BEFORE MANUAL SCREW PLACEMENT." }, { "mdr_text_key": "362721437", "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. ARTICLE CITATION WAS INCLUDED. 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. CONTINUATION OF SECTION B5) 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." } ], "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": "" } ] }