{ "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": "3005075696-2026-00111", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20260702", "manufacturer_address_2": "", "pma_pmn_number": "K230064", "date_of_event": "20260119", "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": "BR", "manufacturer_contact_area_code": "", "date_added": "20260702", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1750344", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260702", "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": "DA", "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" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/10/2026", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260706", "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": "20260702", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Rupture", "Unspecified Nervous System Problem" ] } ], "distributor_city": "", "date_report": "20260706", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "25691938", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260610", "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": "406286176", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "E0139: NEUROLOGICAL DEFICIT E2013: RUPTURE OF THE VERTEBRAL PEDICLE WALL G2: THIS EVENT OCCURRED IN BRAZIL, SEE SECTION E. H3, H6: NO PRODUCTS WERE RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. 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": "406286177", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "CITATION: HTTP://DX.DOI.ORG/10.1590/S1808-185120262501303235. SUMMARY: OBJECTIVE: TO ANALYZE THE LIMITATIONS AND COMPLICATIONS OF USING A ROBOTIC SYSTEM IN SPINAL SURGERIES DURING THE LEARNING CURVE. METHODS: TO EVALUATE THE RESULTS OF THE APPLICATION OF 415 PEDICLE SCREWS IN 67 PATIENTS UNDERGOING SPINAL SURGERY IN WHICH THE ROBOTIC SYSTEM WAS USED. RECORDING TIME, FLUOROSCOPY TIME, INTRAOPERATIVE RADIATION DOSE, IMPLANT ACCURACY, ABANDONMENT OF THE ROBOTIC SYSTEM, PROBLEMS WITH THE SYSTEM PROGRAM, AND CLINICAL COMPLICATIONS WERE EVALUATED. RESULTS: DISCREPANT VALUES WERE OBSERVED IN RECORDING TIME IN 9 (13.43%) PATIENTS, IN FLUOROSCOPY TIME IN 3 (4.47%), AND IN INTRAOPERATIVE RADIATION DOSE IN 8 (11.94%). MALPOSITIONING (VERTEBRAL PEDICLE WALL RUPTURE > 2 MM) OCCURRED IN 3.5% OF THE IMPLANTS EVALUATED IN THE AXIAL PLANE AND 0.48% IN THE SAGITTAL PLANE. NO ABANDONMENT OF THE ROBOTIC SYSTEM WAS OBSERVED. NEUROLOGICAL DEFICIT WAS OBSERVED IN ONE PATIENT. CONCLUSIONS: THE ROBOTIC SYSTEM DEMONSTRATED EFFECTIVENESS AND PRECISION IN IMPLANT PLACEMENT, BUT SYSTEM LIMITATIONS WERE OBSERVED, MAINLY RELATED TO THE ACQUISITION OF GOOD-QUALITY IMAGES FOR SYSTEM REGISTRATION. LEVEL OF EVIDENCE IV; CASE SERIES. REPORTED EVENT(S): THIS ARTICLE REVIEWED THE CASES OF 67 PATIENTS. MISPLACEMENT ACCORDING TO THE ESTABLISHED CRITERION (RUPTURE OF THE VERTEBRAL PEDICLE WALL > 2MM) OCCURRED IN 3.5% OF THE IMPLANTS EVALUATED IN THE AXIAL PLANE AND 0.48% IN THE SAGITTAL PLANE. NEUROLOGICAL DEFICIT WAS OBSERVED IN 1 (1.49%) PATIENT DUE TO VIOLATION OF THE VERTEBRAL CANAL DURING THE PREPARATION OF THE PILOT HOLE. THE PATIENT HAD A VERTEBRAL FRACTURE AND THE DISPLACEMENT OF THE FRAGMENT OCCURRED DURING THE SURGICAL PROCEDURE, LEADING TO THE RECORDING ERROR." } ], "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": "07/06/2026" } ] }