{ "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": "*", "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": "3005075696-2019-00003", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20190214", "manufacturer_address_2": "", "pma_pmn_number": "K180307", "date_of_event": "20190117", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "BIOMEDICAL ENGINEER", "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": "", "manufacturer_contact_area_code": "", "date_added": "20190214", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "133812", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190214", "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": "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250821", "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": "20190214", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Life Threatening" ], "patient_age": "49 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Iatrogenic Source", "Iatrogenic Source" ] } ], "distributor_city": "", "date_report": "20190214", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8338811", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190117", "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": "136118313", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "EXEMPTION NUMBER E2017043. (B)(4)." }, { "mdr_text_key": "136118314", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "FOLLOWING A SURGERY USING MAZOR X SYSTEM, AT (B)(6) INTERNATIONAL HOSPITAL (B)(6), ON (B)(6) 2019, IT WAS REPORTED THAT WHILE USING THE SYSTEM TO DIRECT DRILLING INTO A VERTEBRA FROM A POSTERIOR DIRECTION, THE VERTEBRAL BODY WAS BREACHED ANTERIORLY AND PERFORATED THE INFERIOR VENA CAVA (IVC). L3-L5 SCREW PLACEMENT WAS PLANNED INTRA-OPERATIVELY USING O-ARM IMAGING. DURING THE PROCEDURE, L3L AND L4L WERE DRILLED USING THE SHORT DRILL GUIDE AND SHORT DRILL BIT. AS SURGEON FELT K-WIRE WAS DEVIATED, INDICATED BY BLOODSTAIN AND BONE ON THE DRILL, FURTHER X-RAY AND 3D IMAGING CONFIRMED THE DRILLS PERFORATED THE FRONT VERTEBRAL BODY. MAZOR X PROCEDURE WAS ABORTED. PATIENT UNDERWENT CT SCAN AND FOUND TEAR VEIN AND BLOOD CONGESTION NEARBY INFERIOR VENA CAVA. THE CLINICAL INVESTIGATION HAD SHOWN THE TRAJECTORIES EXECUTED WERE ACCURATE WITHIN THE PEDICLE AND PER PLAN, IN BOTH AXIAL & SAGITTAL PLANES. AS THERE ARE NO ISSUES OF ABNORMAL ANATOMY OR PLATFORM MOUNTING OR EVIDENCE FOR MALFUNCTION, IT WAS CONCLUDED THAT THE ROOT CAUSE FOR THE ANTERIOR BREACHING DURING THE MAZOR X PROCEDURE IS INCORRECT HARDWARE USE. IT IS PROBABLE THAT THERE WAS DEVIATION FROM SURGICAL TECHNIQUE, MANIFESTED AS USING AN INCORRECT LONGER DRILL." } ], "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": "" } ] }