{ "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": "HOSPITAL", "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": "3005075696-2018-00031", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20181115", "manufacturer_address_2": "", "pma_pmn_number": "K180307", "date_of_event": "20170518", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "report_date": "20181026", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "DISTRIBUTOR" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20181115", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "915680", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20181115", "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": "1 MO", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "7290109180465", "udi_public": "017290109180465", "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": "CO", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250820", "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": "20181115", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "58 YR", "patient_sex": "", "patient_weight": "85", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Iatrogenic Source", "Iatrogenic Source" ] } ], "distributor_city": "", "date_report": "20181115", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "date_report_to_manufacturer": "20181026", "manufacturer_contact_city": "", "mdr_report_key": "8073091", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20181026", "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": "127210182", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "EXEMPTION NUMBER E2017043. (B)(4)." }, { "mdr_text_key": "127210183", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "FOLLOWING A SURGICAL PROCEDURE USING THE MAZOR X SYSTEM AT (B)(6), BACK ON (B)(6) 2017, IT WAS REPORTED TO MAZOR (ON (B)(6) 2018) BY (B)(4), THE MAZOR X DISTRIBUTOR, THAT THE PATIENT COMPLAINED THROUGH (B)(4) FACEBOOK THAT DURING THIS CASE NEARLY HALF OF THE SCREWS THAT WERE PLACED FROM T10-S1 WERE MISALIGNED TO VARYING DEGREES. THE SURGEON DECIDED TO DO A REVISION ON (B)(6) 2017. DURING THE REVISION SURGERY THE SURGEON REMOVED ALL THE DEVIATED SCREWS AND DID NOT PLACE NEW SCREWS OR ANY HARDWARE INSTEAD. 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