{ "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": "8200 CORAL SEA STREET NE MVS21", "manufacturer_g1_city": "CAESAREA HEFA,IL", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "76352656", "event_type": "Injury", "report_number": "3005075696-2023-00043", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20230802", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20230608", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55112", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7635265677", "noe_summarized": "1", "manufacturer_contact_l_name": "ELLIS", "source_type": [ "Foreign", "Literature", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079567", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "763", "date_added": "20230802", "manufacturer_contact_f_name": "JUSTIN", "device_date_of_manufacturer": "20200805", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1158050", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230802", "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": "N", "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": [ "Incorrect, Inadequate or Imprecise Result or Readings", "Adverse Event Without Identified Device or Use Problem", "Incorrect, Inadequate or Imprecise Result or Readings", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/08/2023;07/27/2023", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250821", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "67", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7635", "patient": [ { "patient_sequence_number": "1", "date_received": "20230802", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention", " O" ], "patient_age": "61 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Infection", "Unspecified Nervous System Problem", "Unspecified Infection", "Unspecified Nervous System Problem" ] } ], "distributor_city": "", "date_report": "20250225", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "17441800", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20230727", "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": "320208151", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.4. THE PATIENT'S WEIGHT WAS NO PROVIDED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS ACCEPTED AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. B.5. INCLUDE THE ARTICLE CITATION D.4. THE SYSTEM SERIAL NUMBER WAS NOT PROVIDED IN THE JOURNAL ARTICLE. H.3. NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. H.4. DEVICE MANUFACTURING DATE WAS UNAVAILABLE. 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." }, { "mdr_text_key": "320208152", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "T. AKAZAWA, Y. TORII, J. UENO ET AL., SAFETY OF ROBOTIC-ASSISTED SCREW PLACEMENT FOR SPINE SURGERY: EXPERIENCE FROM THE INITIAL 125 CASES, JOURNAL OF ORTHOPAEDIC SCIENCE, HTTPS://DOI.ORG/10.1016/J.JOS.2023.06.003 SUMMARY: THE PRESENT STUDY AIMED TO EVALUATE THE SAFETY OF ROBOT-ASSISTED SCREW PLACEMENT IN 125 CASES AFTER INTRODUCING A SPINAL ROBOTICS SYSTEM AND TO IDENTIFY THE SITUATIONS WHERE DEVIATION WAS LIKELY TO OCCUR. THE SUBJECTS WERE 125 CONSECUTIVE PATIENTS WHO UNDERWENT ROBOTIC-ASSISTED SCREW PLACEMENT USING A SPINAL ROBOTICS SYSTEM (MAZOR X STEALTH EDITION, MEDTRONIC) FROM APRIL 2021 TO JANUARY 2023. THE 1048 SCREWS PLACED WITH ROBOTIC ASSISTANCE WERE EVALUATED. WE INVESTIGATED INTRAOPERATIVE ADVERSE EVENTS OF THE ROBOTICS SYSTEM AND COMPLICATIONS OCCURRING WITHIN 30 DAYS AFTER SURGERY. WE EVALUATED SCREW ACCURACY AND DEVIATION AND COMPARED THEM FOR VERTEBRAL LEVELS, SCREW INSERTION METHODS (OPEN TRADITIONAL PEDICLE SCREW [OPEN-PS], CORTICAL BONE TRAJECTORY SCREW [CBT], PERCUTANEOUS PEDICLE SCREW [PPS], AND S2 ALAR ILIAC SCREW [S2AIS]), DIAGNOSIS, AND PHASES OF SURGICAL CASES. THE DEVIATION RATE OF ROBOTIC-ASSISTED SCREW PLACEMENT FOR SPINE SURGERY WAS 2.2%. COMPLICATIONS WERE REOPERATION DUE TO IMPLANT-RELATED NEUROLOGICAL DEFICIT IN 0.8% AND SURGICAL SITE INFECTION IN 0.8%. THERE WAS SIGNIFICANT DIFFERENCE IN THE DEVIATION RATE BETWEEN VERTEBRAL LEVELS. THE DEVIATION RATE OF THE T1ET4LEVEL WAS HIGH AT 10.0%. THERE WAS SIGNIFICANT DIFFERENCE IN THE DEVIATION RATE BETWEEN OPEN- PS, CBT, PPS, AND S2AIS. THE PPSS HAD A HIGH DEVIATION RATE OF 10.3%. THE DEVIATION RATES WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN PATIENTS WITH AND WITHOUT DEFORMITY. THE DEVIATION RATE DID NOT CHANGE DEPENDING ON THE EXPERIENCE OF SURGICAL CASES, AND THE DEVIATION RATE WAS FAVORABLE FROM THE ONSET. ALTHOUGH THE ROBOTIC-ASSISTED SCREW PLACEMENT WAS SAFE, WE SHOULD BE EXTRA VIGILANT WHEN PLACING SCREWS IN THE UPPER THORACIC REGION (DEVIATION RATE 10.0%) AND WHEN USING PPSS (DEVIATION RATE 10.3%). REPORTED EVENTS: ONE HUNDRED AND TWENTY FIVE PATIENTS UNDERWENT A ROBOTIC-ASSISTED SCREW PLACEMENT TO ADDRESS VARYING SPINAL ISSUES. DURING ONE OF THESE CASES A PATIENT HAD TO BE RE-OPERATED DUE TO AN IMPLANT-RELATED NEUROLOGICAL DEFICIT. IN ANOTHER CASE, A PATIENT DEVELOPED A SURGICAL SITE INFECTION." }, { "mdr_text_key": "336766795", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4: THE SERIAL NUMBER OF THE SYSTEM WAS PROVIDED. G2: MANUFACTURER REPRESENTATIVE PROVIDED INFORMATION. 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." }, { "mdr_text_key": "364917173", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. B5) UPDATED TO INCLUDE THE ALLEGATIONS OF INACCURACY. H6) UPDATED TO INCLUDE APPROPRIATE DEVICE CODE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN." }, { "mdr_text_key": "364917174", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "T. AKAZAWA, Y. TORII, J. UENO ET AL., SAFETY OF ROBOTIC-ASSISTED SCREW PLACEMENT FOR SPINE SURGERY: EXPERIENCE FROM THE INITIAL 125 CASES, JOURNAL OF ORTHOPAEDIC SCIENCE, HTTPS://DOI.ORG/10.1016/J.JOS.2023.06.003 BACKGROUND: THE PRESENT STUDY AIMED TO EVALUATE THE SAFETY OF ROBOT-ASSISTED SCREW PLACEMENT IN 125 CASES AFTER INTRODUCING A SPINAL ROBOTICS SYSTEM AND TO IDENTIFY THE SITUATIONS WHERE DEVIATION WAS LIKELY TO OCCUR. METHODS: THE SUBJECTS WERE 125 CONSECUTIVE PATIENTS WHO UNDERWENT ROBOTIC-ASSISTED SCREW PLACEMENT USING A SPINAL ROBOTICS SYSTEM (MAZOR X STEALTH EDITION, MEDTRONIC) FROM APRIL 2021 TO JANUARY 2023. THE 1048 SCREWS PLACED WITH ROBOTIC ASSISTANCE WERE EVALUATED. WE INVESTIGATED INTRAOPERATIVE ADVERSE EVENTS OF THE ROBOTICS SYSTEM AND COMPLICATIONS OCCURRING WITHIN 30 DAYS AFTER SURGERY. WE EVALUATED SCREW ACCURACY AND DEVIATION AND COMPARED THEM FOR VERTEBRAL LEVELS, SCREW INSERTION METHODS (OPEN TRADITIONAL PEDICLE SCREW [OPEN-PS], CORTICAL BONE TRAJECTORY SCREW [CBT], PERCUTANEOUS PEDICLE SCREW [PPS], AND S2 ALAR ILIAC SCREW [S2AIS]), DIAGNOSIS, AND PHASES OF SURGICAL CASES. RESULTS: THE DEVIATION RATE OF ROBOTIC-ASSISTED SCREW PLACEMENT FOR SPINE SURGERY WAS 2.2%. COMPLICATIONS WERE REOPERATION DUE TO IM PLANT-RELATED NEUROLOGICAL DEFICIT IN 0.8% AND SURGICAL SITE INFECTION IN 0.8%. THERE WAS SIGNIFICANT DIFFERENCE IN THE DEVIATION RATE BETWEEN VERTEBRAL LEVELS. THE DEVIATION RATE OF THE T1ET4LEVEL WAS HIGH AT 10.0%. THERE WAS SIGNIFICANT DIFFERENCE IN THE DEVIATION RATE BETWEEN OPEN- PS, CBT, PPS, AND S2AIS. THE PPSS HAD A HIGH DEVIATION RATE OF 10.3%. THE DEVIATION RATES WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN PATIENTS WITH AND WITHOUT DEFORMITY. THE DEVIATION RATE DID NOT CHANGE DEPENDING ON THE EXPERIENCE OF SURGICAL CASES, AND THE DEVIATION RATE WAS FAVORABLE FROM THE ONSET. CONCLUSION: ALTHOUGH THE ROBOTIC-ASSISTED SCREW PLACEMENT WAS SAFE, WE SHOULD BE EXTRA VIGILANT WHEN PLACING SCREWS IN THE UPPER THORACIC REGION (DEVIATION RATE 10.0%) AND WHEN USING PPSS (DEVIATION RATE 10.3%). REPORTED EVENTS ONE HUNDRED AND TWENTY-FIVE PATIENTS UNDERWENT A ROBOTIC-ASSISTED SCREW PLACEMENT TO ADDRESS VARYING SPINAL ISSUES. DURING ONE OF THESE CASES A PATIENT HAD TO BE REOPERATED DUE TO AN IMPLANT-RELATED NEUROLOGICAL DEFICIT. IN ANOTHER CASE, A PATIENT DEVELOPED A SURGICAL SITE INFECTION. ONE HUNDRED AND TWENTY-FIVE PATIENTS UNDERWENT A ROBOTIC-ASSISTED SCREW PLACEMENT TO ADDRESS VARYING SPINAL ISSUES. TWENTY-FIVE SCREWS WERE DETERMINED TO BE DEVIATED. TWENTY-ONE WERE DEVIATED BETWEEN TWO TO FOUR MILLIMETERS, ONE SCREW WAS DEVIATED FOUR TO SIX MILLIMETERS, AND ONE SCREW WAS DEVIATED MORE THAN SIX MILLIMETERS. THIRTEEN SCREWS WERE NOTED TO BE MEDIAL, NINE WERE LATERAL, AND ONE WAS A CRANIAL BREACH." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "5 SHACHAM STREET", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55112", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/31/2023;02/25/2025" } ] }