{ "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": "3005075696-2020-00106", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200825", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20200813", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200825", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "913774", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200825", "brand_name": "MAZOR X STEALTH EDITION", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAZOR ROBOTICS LTD", "manufacturer_d_address_1": "5 SHACHAM STREET", "manufacturer_d_address_2": "P.O. BOX 3104", "manufacturer_d_city": "CAESAREA HEFA,IL", "manufacturer_d_state": "", "manufacturer_d_zip_code": "30795", "manufacturer_d_zip_code_ext": "67", "manufacturer_d_country": "IL", "manufacturer_d_postal_code": "3079567", "device_operator": "HEALTH PROFESSIONAL", "model_number": "TPL0059", "catalog_number": "TPL0059", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200813", "device_report_product_code": "OLO", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "07290109181158", "udi_public": "07290109181158", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Use of Device Problem", "Use of Device Problem" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20200825", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "56 YR", "patient_sex": "", "patient_weight": "75", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Muscle Weakness/Atrophy", "Pain", "Muscle Weakness/Atrophy", "Pain" ] } ], "distributor_city": "", "date_report": "20200825", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10449825", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200813", "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": "204251692", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "SOFTWARE ANALYSIS WAS COMPLETED. CLINICAL EXPORT DATA FILE WAS THOROUGHLY INSPECTED. THE LOG FILE WAS EXAMINED WITH RESPECT TO ALL INTRAOPERATIVE FLUORO IMAGES IN ORDER TO INSPECT AND UNDERSTAND PROCEDURE WORKFLOW. FLUORO IMAGES WERE CHECKED AND 3D REGISTRATION WAS ATTEMPTED WITH THE REGISTRATION 3D MARKER IMAGES UTILIZED DURING THE OPERATION. ANALYSIS REVIEWED THE PLANNING AND NOTICED LATERAL SKIVING POTENTIAL AT L3 AND L4 VERTEBRAE. THE SCREWS WERE PLANNED AS CORTICAL SCREWS AND PLACED ON THE SLOP OF A VERY DENSE CORTICAL BONE. THE REGISTRATION WAS UPLOADED, PERFORMED AND VALIDATED TO BE ACCURATE. THE CASE WAS PERFORMED AS AN OPEN CASE AND THE INCISION PERFORMED ABOVE L4 VERTEBRA. ACCORDING TO THE PROVIDED INTRA-OP FLUORO IMAGE OF THE INCISION, IT CAN BE NOTICED THAT THE INCISION PROVIDES GOOD APPROACH TO L4, BUT ONLY EXPOSED THE LOWER PORTION OF L3. IF NO ADDITIONAL INCISION WAS PERFORMED, A SOFT TISSUE PRESSURE WOULD APPLY ON THE TOOLS AND CAN CAUSE THE SCREWS TO DEVIATE. BONE MOUNT BRIDGE WAS USED, AND NO MAJOR ISSUES WERE DETECTED. ANALYSIS INSPECTED ALL PROVIDED INFORMATION AND CONCLUDED THAT THE MOST PROBABLE CAUSES FOR THE DEVIATIONS AT L3 LEFT AND RIGHT AND L4 RIGHT WAS SKIVING OF THE TOOLS ON THE BONE AND SOFT TISSUE PRESSURE DUE TO SMALL INCISION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "204251733", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED INTRA-OPERATIVELY OF A SPINAL PROCEDURE. IT WAS REPORTED THAT A SCREW DEVIATION WAS DISCOVERED. THE SCREWS WERE IMPLANTED DURING A L3-L4 CASE ON (B)(6) 2020 WITH NO ISSUES. THE SITE HAD TAKEN AP SHOTS TO CONFIRM SCREW PLACEMENT AFTER THE CASE; HOWEVER, THEY WERE UNABLE TO IDENTIFY THE DEVIATION FROM THOSE SHOTS. ON (B)(6) 2020, IT WAS DISCOVERED THAT THERE WAS A DEVIATION WHEN THE PA DID A FOLLOW UP VISIT WITH THE PATIENT SINCE THEY WERE STILL EXPERIENCING NERVE PAIN AND WEAKNESS IN THEIR LEGS. IT APPEARS THAT THE LEFT AND RIGHT L3 SCREWS ARE LATERAL BY 6 MM AND ARE NOT WITHIN THE PEDICLE. THE RIGHT L4 IS LATERAL BY 6 MM. BOTH MEASUREMENTS ARE APPROXIMATE FROM THE DISTAL END OF THE SCREW. THE REVISION PROCEDURE HAD NOT BEEN SCHEDULED. THE INITIAL PROCEDURE WAS NOT DELAYED." } ], "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": "" } ] }