{ "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": "3005075696-2021-00089", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20210803", "manufacturer_address_2": "", "pma_pmn_number": "K180307", "date_of_event": "20210512", "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": [ "HEALTH PROFESSIONAL", "LITERATUR" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20210803", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1162679", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210803", "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": "DA", "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": "08/03/2021", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20210803", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Erosion", "Cerebrospinal Fluid Leakage", "Nerve Damage", "Unspecified Nervous System Problem", "Insufficient Information", "Erosion", "Cerebrospinal Fluid Leakage", "Nerve Damage", "Unspecified Nervous System Problem", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20210803", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "12269139", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20210803", "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": "265763918", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "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: LEE N, ZUCKERMAN S, BUCHANAN I, BODDAPATI V, MATHEW J, LEUNG E, PARK P, PHAM M, BUCHOLZ A, KHAN A, POLLINA J, MULLIN J, JAZINI E, HAINES C, SCHULER T, GOOD C, LOMBARDI J, LEHMAN R. IS THERE A DIFFERENCE BETWEEN NAVIGATED AND NON-NAVIGATED ROBOT COHORTS IN ROBOT-ASSISTED SPINE SURGERY? A MULTICENTER, PROPENSITY-MATCHED ANALYSIS OF 2,800 SCREWS AND 372 PATIENTS. THE SPINE JOURNAL. 2021. 1-9. HTT PS://DOI.ORG/10.1016/J.SPINEE.2021.05.015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "265763919", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ABSTRACT: ROBOT-ASSISTED SPINE SURGERY CONTINUES TO RAPIDLY DEVELOP AS EVIDENCED BY THE GROWING LITERATURE IN RECENT YEARS. IN ADDITION TO DEMONSTRATING EXCELLENT PEDICLE SCREW ACCURACY, EARLY STUDIES HAVE EXPLORED THE IMPACT OF ROBOT-ASSISTED SPINE SURGERY ON REDUCING RADIATION TIME, LENGTH OF HOSPITAL STAY, OPERATIVE TIME, AND PERIOPERATIVE COMPLICATIONS IN COMPARISON TO CONVENTIONAL FREEHAND TECHNIQUE. RECENTLY, THE MAZOR X STEALTH EDITION WAS INTRODUCED IN 2018. THIS ROBOTIC SYSTEM INTEGRATES MEDTRONIC¿S STEALTH NAVIGATION TECHNOLOGY INTO THE MAZOR X PLATFORM, WHICH WAS INTRODUCED IN 2016. IT IS UNCLEAR WHAT THE IMPACT OF THESE ADVANCEMENTS HAVE MADE ON CLINICAL OUTCOMES. TO COMPARE THE OUTCOMES AND COMPLICATIONS BETWEEN THE MOST RECENT ITERATIONS OF THE MAZOR ROBOT SYSTEMS: MAZOR X AND MAZOR X STEALTH EDITION. AMONG FOUR DIFFERENT INSTITUTIONS, WE INCLUDED ADULT (=18 YEARS OLD) PATIENTS WHO UNDERWENT ROBOT-ASSISTED SPINE SURGERY WITH EITHER THE MAZOR X (NON-NAVIGATED ROBOT) OR STEALTH (NAVIGATED ROBOT) PLATFORMS. PRIMARY OUTCOMES INCLUDED ROBOT TIME PER SCREW, FLUOROSCOPIC RADIATION TIME, SCREW ACCURACY, ROBOT ABANDONMENT, AND CLINICAL OUTCOMES WITH A MINIMUM 90 DAY FOLLOW UP. A ONE-TO-ONE PROPENSITY-SCORE MATCHING ALGORITHM BASED ON PERIOPERATIVE FACTORS (E.G. DEMOGRAPHICS, COMORBIDITIES, PRIMARY DIAGNOSIS, OPEN VS. PERCUTANEOUS INSTRUMENTATION, PRIOR SPINE SURGERY, INSTRUMENTED LEVELS, PELVIC FIXATION, INTERBODY FUSION, NUMBER OF PLANNED ROBOT SCREWS) WAS EMPLOYED TO CONTROL FOR THE POTENTIAL SELECTION BIAS BETWEEN THE TWO ROBOTIC SYSTEMS. CHI-SQUARE/ FISHER EXACT TEST AND T-TEST/ANOVA WERE USED FOR CATEGORICAL AND CONTINUOUS VARIABLES, RESPECTIVELY. FROM A TOTAL OF 646 PATIENTS, A TOTAL OF 372 ADULT PATIENTS WERE INCLUDED IN THIS STUDY (X: 186, STEALTH: 186) AFTER PROPENSITY SCORE MATCHING. THE MEAN NUMBER OF INSTRUMENTED LEVELS WAS 4.3. THE MEAN NUMBER OF PLANNED ROBOT SCREWS WAS 7.8. SIMILAR TOTAL OPERATIVE TIME AND ROBOT TIME PER SCREW OCCURRED BETWEEN COHORTS (P>0.05). HOWEVER, STEALTH ACHIEVED SIGNIFICANTLY SHORTER FLUOROSCOPIC RADIATION TIME PER SCREW (STEALTH: 7.2 SECONDS VS. X: 10.4 SECONDS, P<(><<)>.001) THAN X. THE SCREW ACCURACY FOR BOTH ROBOTS WAS EXCELLENT (STEALTH: 99.6% VS. X: 99.1%, P=0.120). IN ADDITION, STEALTH ACHIEVED A SIGNIFICANTLY LOWER ROBOT ABANDONMENT RATE (STEALTH: 0% VS. X: 2.2%, P=0.044). FURTHERMORE, A LOWER BLOOD TRANSFUSION RATE WAS OBSERVED FOR STEALTH THAN X (STEALTH: 4.3% VS. X: 10.8%, P=0.018). NON-ROBOT RELATED COMPLICATIONS SUCH AS DURA TEAR, MOTOR/SENSORY DEFICITS, RETURN TO THE OPERATING ROOM DURING SAME ADMISSION, AND LENGTH OF STAY WAS SIMILAR BETWEEN ROBOTS (P>0.05). THE 90-DAY COMPLICATION RATES WERE LOW AND SIMILAR BETWEEN ROBOT COHORTS (STEALTH: 5.4% VS. X: 3.8%, P=0.456). IN THIS MULTICENTER STUDY, BOTH ROBOT SYSTEMS ACHIEVED EXCELLENT SCREW ACCURACY AND LOW ROBOT TIME PER SCREW. HOWEVER, USING STEALTH LED TO SIGNIFICANTLY LESS FLUOROSCOPIC RADIATION TIME, LOWER ROBOT ABANDONMENT RATES, AND REDUCED BLOOD TRANSFUSION RATES THAN MAZOR X. OTHER FACTORS INCLUDING LENGTH OF STAY, AND 90-DAY COMPLICATIONS WERE SIMILAR. REPORTED EVENT: AFTER USE OF THE GUIDANCE SYSTEM DURING SPINAL PROCEDURES, THERE WERE SEVEN OCCURRENCES OF INTRAOPERATIVE DURAL TEARS, TWO OCCURRENCES OF INTRAOPERATIVE LOSS OF MOTOR/SENSORY FUNCTION, AND TWO OCCURRENCES OF A REVISION PROCEDURE BEING REQUIRED. DURING THE 90 DAY FOLLOW UP PERIOD AFTER THE USE OF THE GUIDANCE SYSTEM DURING SPINAL PROCEDURES, THERE WERE FOUR OCCURRENCES OF WOUND COMPLICATIONS, ONE OCCURRENCE OF NEUROLOGIC DEFICIT, ONE OCCURRENCE OF PERSISTENT SYMPTOMS REQUIRING DECOMPRESSION, AND ONE OCCURRENCE OF AN UNKNOWN SYMPTOM THAT REQUIRED REOPERATION." }, { "mdr_text_key": "325954686", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "PMA/510K NUMBER WAS UPDATED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." } ], "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": "08/03/2021" } ] }