{ "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": "CAESAREA BUSINESS PARK", "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": "3005075696-2025-00416", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20251222", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20250718", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55112", "reporter_occupation_code": "PHYSICIAN ASSISTANT", "manufacturer_contact_plocal": "7635265677", "noe_summarized": "1", "manufacturer_contact_l_name": "ELLIS", "source_type": [ "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20251222", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2270803", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251222", "brand_name": "MAZOR X SYSTEM", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAZOR ROBOTICS LTD", "manufacturer_d_address_1": "1 HAESHEL STREET. (BUILDING C)", "manufacturer_d_address_2": "CAESAREA BUSINESS PARK", "manufacturer_d_city": "CAESAREA HEFA,IL", "manufacturer_d_state": "", "manufacturer_d_zip_code": "30798", "manufacturer_d_zip_code_ext": "30", "manufacturer_d_country": "IS", "manufacturer_d_postal_code": "3079830", "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": "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", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20251223", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "30", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7635", "patient": [ { "patient_sequence_number": "1", "date_received": "20251222", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " L" ], "patient_age": "60 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Dural Tear", "Bacterial Infection", "Cerebrospinal Fluid Leakage", "Hematoma", "Urinary Retention", "Post Operative Wound Infection", "Unspecified Nervous System Problem", "Thrombosis/Thrombus", "Insufficient Information", "Dural Tear", "Bacterial Infection", "Cerebrospinal Fluid Leakage", "Hematoma", "Urinary Retention", "Post Operative Wound Infection", "Unspecified Nervous System Problem", "Thrombosis/Thrombus", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20251222", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "23868758", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20251202", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "30798", "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": "388347301", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A.1-A.5) PATIENT INFORMATION WAS INCLUDED IN THE JOURNAL. A.2. THIS VALUE IS THE MEDIAN 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 NOT PROVIDED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS PUBLISHED AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. B.5. INCLUDED 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. H.6. MULTIPLE PATIENT CODES WERE APPLIED. BELOW LISTED WHAT EACH CORRELATES TO. E0144 - DUROTOMY E0106 - CSF E0139 - NEUROLOGICAL DEFICIT E0505 - HEMATOMA E0514 - DVT E1309 - URINARY RETENTION/FOLEY INSERTION E1901 - PNEUMONIA E2115 - WOUND INFECTION E2401 - IMPLANT-RELATED TRANSIENT DECREASE IN MOTOR SIGNALS, VASCULAR INJURY, MOTOR LOSS, IMPLANT FAILURE, INTERBODY CAGE COMPLICATION 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": "388347302", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "OROSZ, L. D., LEE, N. J., GUM, J. L., LEHMAN, R. A., HAGE, T. R., KATZ, J., AMELL-ANGST, T., ROY, R. T., POULTER, G. T., HAINES, C. M., JAZINI, E., GOOD, C. R. (2025). NINETY-DAY COMPLICATION AND REVISION SURGERY RATES USING NAVIGATED ROBOTICS IN THORACOLUMBAR SPINE SURGERY: A PROGRSS INTERIM ANALYSIS. INTERNATIONAL JOURNAL OF SPINE SURGERY, 19(4), 437¿443. HTTPS://DOI.ORG/10.14444/8777 SUMMARY: BACKGROUND: INDIVIDUALLY, ROBOTIC GUIDANCE AND 3-DIMENSIONAL NAVIGATION ASSISTANCE HAVE BEEN SHOWN TO IMPROVE SURGICAL OUTCOMES AND ACCURACY IN SPINE SURGERY. THE PAIRING OF THESE TECHNOLOGIES MAY FURTHER IMPROVE OUTCOMES; HOWEVER, DATA ARE NEEDED TO SUPPORT THIS THEORY. IN THE PROSPECTIVE ROBOTIC-GUIDED REGISTRY OF SPINE SURGERY (PROGRSS), OUTCOMES WERE TRACKED FOR CASES USING A BONE-MOUNTED INTEGRATED ROBOTIC-ASSISTED NAVIGATION SYSTEM. THIS INTERIM ANALYSIS REPORTS ON 90-DAY COMPLICATIONS AND REVISIONS. METHODS: ADULTS UNDERGOING NAVIGATED ROBOTIC THORACOLUMBAR SURGERY FROM 2020 TO 2022 WERE PROSPECTIVELY ENROLLED BY 6 SURGEONS AT 4 DISTINCT CENTERS. MEDICAL, SURGICAL, AND ROBOT-RELATED COMPLICATIONS AND REVISION SURGERIES WERE COLLECTED POSTOPERATIVELY FOR UP TO 90 DAYS AND ANALYZED. RESULTS: OF 411 SURGERIES, 3469 SCREWS WERE IMPLANTED. THE MEAN NUMBER OF LEVELS FUSED WAS 4.4 ± 3.7. INTRAOPERATIVE ADVERSE EVENTS OCCURRED IN 4.1% OF CASES, AND 0.5% WERE ROBOT RELATED. THE FREQUENCY OF PATIENTS WITH AT LEAST 1 POSTOPERATIVE SURGICAL COMPLICATION WAS 6.6%, NONE BEING ROBOT RELATED. THE FREQUENCY OF PATIENTS WITH AT LEAST 1 POSTOPERATIVE MEDICAL COMPLICATION WAS 18.2%. THE REVISION SURGERY RATE AT 90 DAYS WAS 1.5%, NONE OF WHICH WERE ROBOT RELATED. CONCLUSION: THIS FIRST-OF-ITS-KIND STUDY OF AN INTEGRATED NAVIGATION AND ROBOTIC SPINE PLATFORM DEMONSTRATES LOW COMPLICATION AND REVISION SURGERY RATES FOR THORACOLUMBAR FUSION. THIS INTERIM ANALYSIS OF PROGRSS SHOWED 4.1% INTRAOPERATIVE COMPLICATIONS, 6.6% POSTOPERATIVE SURGICAL COMPLICATIONS, AND 1.5% REVISION SURGERIES. WITH ADVANCEMENTS IN TECHNOLOGY AND INCREASED SURGICAL EXPERTISE, NAVIGATED ROBOTICS CONTINUES TO DEMONSTRATE CONSISTENTLY LOW RATES OF 90-DAY COMPLICATIONS AND REVISION SURGERIES, SUPPORTING ITS RELIABILITY. CLINICAL RELEVANCE: THE INTERIM ANALYSIS OF PROGRSS SUGGESTS THAT THE INTEGRATION OF ROBOTIC GUIDANCE WITH 3-DIMENSIONAL NAVIGATION IS REPRODUCIBLY EFFECTIVE IN THE SURGICAL SETTING. LEVEL OF EVIDENCE: 2. REPORTED EVENT 411 PATIENTS UNDERWENT NAVIGATED ROBOTIC THORACOLUMBAR SURGERY. A TOTAL OF 3542 SCREWS WERE PLANNED, BUT ONLY 3491 SCREWS WERE CAPTURED DURING REGISTRATION, THUS LEADING TO A TOTAL OF 3469 SCREW TO BE EXECUTED. OF THE SCREWS EXECUTED 35 WERE DEEMED TO BE MISPLACED, WHERE MISPLACED IS DEFINED AS ANY SCREW THAT WAS REVISED, REPLACED, OR REMOVED PRIOR TO THE END OF THE PROCEDURE. 17 PATIENTS WERE NOTED TO HAVE AT LEAST ONE SURGICAL COMPLICATION. 2 INTRA-OP COMPLICATIONS WERE RELATED TO THE GUIDANCE SYSTEM, WHERE THERE WAS ONE OCCURRENCE OF A DUROTOMY DURING A DEFORMITY CORRECTION CASE, AND ONE OCCURRENCE OF IMPLANT RELATED TRANSIENT DECREASE IN MOTOR SIGNALS. THE 15 OTHER PATIENTS WITH AT LEAST ONE SURGICAL COMPLICATION WERE CONSIDERED UNRELATED TO THE ROBOT. INTRA-OP, THERE WERE 11 DUROTOMY, 11 VASCULAR INJURY, ONE OCCURRENCE OF MOTOR LOSS, AND AN INTERBODY CAGE COMPLICATION. WHILE STILL AT THE HOSPITAL THERE WAS A DOCUMENTATION OF NEUROLOGICAL DEFICIT, 3 HEMATOMAS, AND 2 DURAL LEAK OR PSEUDOMENINGOCELE. THESE COMPLICATIONS CAME FROM 6 PATIENTS, ALL UNRELATED TO THE GUIDANCE SYSTEM. AT THE 14 DAY POST-OP FOLLOW UP 12 PATIENTS REPORTED AT LEAST ONE SURGICAL COMPLICATIONS THAT WAS UNRELATED TO THE GUIDANCE SYSTEM. THERE WERE 7 WOUND INFECTIONS, 1 IMPLANT FAILURE, 1 DURAL LEAK OR PSEUDOMENINGOCELE, 1 TRAUMA AFFECTING CONSTRUCT, AND 2 REPORTS OF 'OTHER' SURGICAL COMPLICATIONS. AT THE 90 DAY FOLLOW UP, 13 PATIENTS REPORTED AT LEAST ONE SURGICAL COMPLICATIONS THAT WAS UNRELATED TO THE GUIDANCE SYSTEM. THERE WERE 4 WOUND INFECTIONS, 5 NEUROLOGICAL DEFICITS, 1 DURAL LEAK OR PSEUDOMENINGOCELE, 1 TRAUMA AFFECTING CONSTRUCT, AND 2 REPORTS OF 'OTHER' SURGICAL COMPLICATIONS. A TOTAL OF 75 PATIENTS EXPERIENCED A MEDICAL COMPLICATION, ALL DETERMINED TO BE UNRELATED TO THE GUIDANCE SYSTEM. WHILE IN THE HOSPITAL, THERE WAS 1 OCCURRENCE OF DEEP VEIN THROMBOSIS(DVT), 1 PULMONARY EMBOLISM(PE), 3 CASES OF PNEUMONIA, 14 ILEUS, 6 URINARY RETENTION/FOLEY INSERTION, AND 10 OCCURRENCES OF 'OTHER' MEDICAL COMPLICATIONS. AT THE 14 DAY FOLLOW UP, THERE WERE 3 CASES OF DVT, 1 PE, 4 ILEUS, 2 URINARY RETENTION/FOLEY INSERTION, 2 TRAUMA NOT AFFECTING CONSTRUCTS, AND 30 OCCURRENCES OF 'OTHER' MEDICAL COMPLICATIONS. AT THE 90 DAY FOLLOW UP, THERE WERE 2 CASES OF PNEUMONIA, 2 CASES OF URINARY RETENTION/FOLEY INSERTION, 2 TRAUMATA NOT AFFECTING CONSTRUCTS, AND 14 OCCURRENCES OF 'OTHER' MEDICAL COMPLICATIONS. IT WAS ALSO NOTED THAT THERE WERE 6 CASES OF REVISION SURGERY ALL UNRELATED TO THE GUIDANCE SYSTEM. SEE ATTACHED LITERATURE ARTICLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "1 HAESHEL STREET. (BUILDING C)", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55112", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }