{ "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": "P.O. BOX 3104", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "7000 CENTRAL AVENUE NE RCW215", "manufacturer_g1_city": "CAESAREA HEFA,IL", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "61227132", "event_type": "Injury", "report_number": "3005075696-2021-00132", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20211213", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20210226", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55432", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "6122713209", "noe_summarized": "1", "manufacturer_contact_l_name": "BELMER", "source_type": [ "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079567", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "612", "date_added": "20211213", "manufacturer_contact_f_name": "GLEN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1889435", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211213", "brand_name": "MAZOR X SYSTEM", "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": "IS", "manufacturer_d_postal_code": "3079567", "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": "", "device_evaluated_by_manufacturer": "*", "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": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250728", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "67", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6122", "patient": [ { "patient_sequence_number": "1", "date_received": "20211213", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Infection", "Unspecified Infection" ] } ], "distributor_city": "", "date_report": "20211213", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MINNEAPOLIS", "mdr_report_key": "12985108", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20211127", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "30795", "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": "287273245", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. THE REPORTED EVENT WAS FROM THE FOLLOWING LITERATURE ARTICLE: MAO J, KHAN A, SOLIMAN M, LEVY B, MCGUIRE M, STARLING R, HESS R, AGYEI J, MEYERS J, MULLIN J, POLLINA J. USE OF THE SCAN-AND-PLAN WORKFLOW IN NEXT-GENERATION ROBOT-ASSISTED PEDICLE SCREW INSERTION: RETROSPECTIVE COHORT STUDY AND LITERATURE REVIEW. WORLD NEUROSURGERY. 2021. E1-E9. HTTPS://DOI.ORG/10.1016/J.WNEU.2021.02.119 IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "287273246", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ABSTRACT: TO REPORT OUR EXPERIENCE USING THE SCAN-AND-PLAN WORKFLOW AND REVIEW CURRENT LITERATURE ON SURGICAL EFFICIENCY, SAFETY, AND ACCURACY OF NEXT-GENERATION ROBOT-ASSISTED (RA) SPINE SURGERY. THE RECORDS OF PATIENTS WHO UNDERWENT RA PEDICLE SCREW FIXATION WERE REVIEWED. THE ACCURACY OF PEDICLE SCREW PLACEMENT WAS DETERMINED BASED ON THE RAVI CLASSIFICATION SYSTEM. TO EVALUATE WORKFLOW EFFICIENCY, 3 DEMOGRAPHICALLY MATCHED COHORTS WERE CREATED TO ANALYZE DIFFERENCES IN TIME PER SCREW PLACEMENT (DEFINED AS OPERATING ROOM [OR] TIME DIVIDED BY NUMBER OF SCREWS PLACED). GROUP A HAD 4 SCREWS PLACED, GROUP B HAD 4 SCREWS PLACED, AND GROUP C HAD >4 SCREWS PLACED. INTRAOPERATIVE ERRORS AND POSTOPERATIVE COMPLICATIONS WERE COLLECTED TO ELUCIDATE SAFETY. EIGHTY-FOUR RA CASES (306 PEDICLE SCREWS) WERE INCLUDED FOR ANALYSIS. THE MEAN NUMBER OF SCREWS PLACED WAS 2.1 +- 0.3 IN GROUP A AND 6.4 +- 1.2 IN GROUP C; 4 SCREWS WERE PLACED IN GROUP B PATIENTS. THE ACCURACY RATE (RAVI GRADE I) WAS 98.4%. SCREW PLACEMENT TIME WAS SIGNIFICANTLY LONGER IN GROUP A (101 +- 37.7 MINUTES) THAN GROUP B (50.5 +- 25.4 MINUTES) OR C (43.6 +- 14.7 MINUTES). THERE WERE NO INTRAOPERATIVE COMPLICATIONS, ROBOT FAILURES, OR IN-HOSPITAL COMPLICATIONS REQUIRING A RETURN TO THE OPERATING ROOM. THE SCAN-AND-PLAN WORKFLOW ALLOWED FOR A HIGH DEGREE OF ACCURACY. IT WAS A SAFE METHOD THAT PROVIDED A SMOOTH AND EFFICIENT OR WORKFLOW WITHOUT REGISTRATION ERRORS OR ROBOTIC FAILURES. AFTER THE PLACEMENT OF 4 PEDICLE SCREWS, THE PER-SCREW TIME REMAINED CONSTANT. FURTHER STUDIES REGARDING EFFICIENCY AND UTILITY IN MULTILEVEL PROCEDURES ARE NECESSARY. REPORTED EVENTS: 1. AFTER USE OF THE GUIDANCE SYSTEM FOR SPINAL SURGERY TO PLACE SCREWS, ONE PATIENT DEVELOPED DISCITIS THAT WAS MANAGED BY CT-GUIDED BIOPSY AND ANTIBIOTICS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "5 SHACHAM STREET", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55432", "manufacturer_contact_exchange": "612", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }