{ "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": "", "event_location": "I", "report_to_fda": "N", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3005075696-2017-00007", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20171111", "manufacturer_address_2": "", "pma_pmn_number": "K163221", "date_of_event": "20171004", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20171111", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "802748", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20171111", "brand_name": "MAZOR X SYSTEM", "generic_name": "STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAZOR ROBOTICS LTD.", "manufacturer_d_address_1": "POB 3104, 5 SHACHAM ST.", "manufacturer_d_address_2": "NORTH INDUSTRIAL PARK", "manufacturer_d_city": "CAESAREA,", "manufacturer_d_state": "", "manufacturer_d_zip_code": "30889", "manufacturer_d_zip_code_ext": "00", "manufacturer_d_country": "IS", "manufacturer_d_postal_code": "3088900", "device_operator": "HEALTH PROFESSIONAL", "model_number": "TPL0059", "catalog_number": "TPL0059", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "HAW", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "07290109180465", "udi_public": "07290109180465", "openfda": { "device_name": "Neurological Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250811", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20171111", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "69 YR", "patient_sex": "", "patient_weight": "76", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Neurological Deficit/Dysfunction", "Neurological Deficit/Dysfunction" ] } ], "distributor_city": "", "date_report": "20171111", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7023542", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20171012", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "91806728", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE REPORTER DID NOT ALLEGE ANY FAILURE OF MALFUNCTION OF THE DEVICE AND NO MALFUNCTION WAS IDENTIFIED (DURING INVESTIGATION). WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE." }, { "mdr_text_key": "91806729", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A COMPLAINT WAS RECEIVED ON (B)(6) 2017, FROM (B)(6) DESCRIBING A SITUATION IN WHICH A PROCEDURE (PERFORMED ON (B)(6) 2017) WENT WELL USING THE MAZOR X SYSTEM. THE SURGEON CONFIRMED THE ACCURACY OF PLACEMENT OF ALL THE PEDICLE SCREWS WHICH WERE PLACED WITH THE GUIDANCE OF THE MAZOR X SYSTEM WITH INTRAOPERATIVE FLUORO CONFIRMATION IMAGES. NEURO-MONITORING WAS ALSO EMPLOYED AND DID NOT INDICATE A BREACH OF THE PEDICLE. HOWEVER, THE NEXT DAY THE PATIENT COMPLAINED OF LEG/RADICULAR NERVE PAIN AND WAS TAKEN BACK TO THE HOSPITAL. THE SURGEON THEN INDICATED THAT SCREWS ON THE RIGHT SIDE WERE MEDIAL, WITH ONE OR MORE IN THE CANAL. THE SURGEON PERFORMED A REVISION AND REPOSITIONED THE SCREWS IN L3 AND L4 BY FREEHAND." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }