{ "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": "3005075696-2025-00115", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250203", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20240917", "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": [ "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": "20250203", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1307583", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250203", "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": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250825", "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": "20250203", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention", " O" ], "patient_age": "60 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bacterial Infection", "Unspecified Infection", "Bacterial Infection", "Unspecified Infection" ] } ], "distributor_city": "", "date_report": "20250203", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "21294375", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250110", "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": "362787507", "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 MEAN 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. 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. E1901 - PNEUMONIA E1906 - POST OPERATIVE INFECTION 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": "362787508", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "GRIEPP, D. W., CASKEY, J., BUNJAJ, A., TURNBULL, J., ALSALAHI, A., ALEXANDER, H., DRAGONETTE, J., SARCAR, B., DESAI, S., TONG, D., SOO, T. M., BONO, P., KELKAR, P., HOUSEMAN, C., CLAUS, C. F., RICHARDS, B. F., CARR, D. A. (2024). IRRADIATION SAFETY, ANESTHESIA TIME, SURGICAL COMPLICATIONS, AND PATIENT-REPORTED OUTCOMES IN THE ROBOTIC MAZOR X VERSUS FLUOROSCOPY GUIDED MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION SURGERY: A COMPARATIVE COHORT STUDY. NEUROSURGICAL FOCUS, 57(6). HTTPS://DOI.ORG/10.3171/2024.9.FOCUS24489 OBJECTIVE: ROBOT-ASSISTED (RA) TECHNOLOGY IS BECOMING MORE WIDELY INTEGRATED AND ACCEPTED IN SPINE SURGERY. THE AUTHORS SOUGHT TO EVALUATE OPERATIVE AND PATIENT-REPORTED OUTCOMES (PROS) IN RA VERSUS FLUOROSCOPY-ASSISTED (FA) PEDICLE SCREW PLACEMENT DURING MINIMALLY INVASIVE SURGERY (MIS) TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). METHODS: THE AUTHORS RETROSPECTIVELY STUDIED ELECTIVE PATIENTS WHO UNDERWENT SINGLE- OR MULTILEVEL MIS TLIF FOR DEGENERATIVE INDICATION USING FA VERSUS RA PEDICLE SCREW PLACEMENT. PATIENTS WERE SELECTED FROM SEPTEMBER 2021 TO MAY 2023 AT A SINGLE INSTITUTION WITH MULTIPLE SURGEONS WHOSE PRACTICE CONSISTS OF PRIMARILY MIS. OUTCOMES INCLUDED FLUOROSCOPY DOSAGE PER SCREW, OPERATIVE TIME PER SCREW, ANESTHESIA TIME PER SCREW, ESTIMATED BLOODLOSS (EBL), SCREW REVISION RATE, INPATIENT SURGICAL COMPLICATIONS, AND MINIMAL CLINICALLY IMPORTANT DIFFERENCE (MCID) OF OSWESTRY DISABILITY INDEX (ODI) AND NUMERIC RATING SCALE (NRS) SCORES AT THE 6- AND 12-MONTH FOLLOW-UPS. COMPARABILITY OF GROUPS WAS ANALYZED BY UNIVARIATE ANALYSIS. MULTIVARIABLE ANALYSIS MODELING FLUOROSCOPY TIME PER SCREW WAS PERFORMED, ADJUSTING FOR CONFOUNDERS. RESULTS: ONE HUNDRED EIGHTY-THREE PATIENTS (N = 133 IN THE FA GROUP VS 50 IN THE RA GROUP) WERE INCLUDED. PATIENTS IN THE RA COHORT WERE SIGNIFICANTLY YOUNGER THAN THOSE IN THE FA GROUP (MEAN AGE 63.8 ± 11.9 VS 59.8 ± 11.0 YEARS, P = 0.037). A TOTAL OF 932 PEDICLE SCREWS WERE PLACED (MEAN 5.1, RANGE 4¿8 PER PATIENT). THE RA COHORT DEMONSTRATED SIGNIFICANTLY LOWER INTRAOPERATIVE FLUOROSCOPY DOSAGE PER SCREW (4.9 ± 7.6 MGY PER SCREW VS 20.3 ± 14.0 MGY PER SCREW, P 0.001), SIGNIFICANTLY LONGER ANESTHESIA TIME PER SCREW (49.1 ± 12.6 VS 43.6 ± 9.2, P = 0.009), AND SIMILAR OPERATIVE TIME PER SCREW (33.3 VS 30.7 MINUTES, P = 0.125). THE SCREW REVISION RATE FOR SYMPTOMATIC RADICULOPATHY WAS ZERO IN BOTH GROUPS. REVISION SURGERY REQUIRING SCREW REMOVAL OR REPOSITION WAS PERFORMED IN 4 TOTAL CASES (RA GROUP: 1/50 FOR INFECTION; FA GROUP: 2/133 FOR INFECTION, 1/133 FOR FORAMINOTOMY). BOTH GROUPS DEMONSTRATED SIGNIFICANT IMPROVEMENT IN PROS AT 6 AND 12 MONTHS COMPARED WITH PREOPERATIVELY. MOREOVER, BOTH GROUPS ACHIEVED MCID AT SIMILAR RATES. CONCLUSIONS: WHEN IMPLEMENTING RA TECHNOLOGY, ONE CAN EXPECT SIMILAR PERIOPERATIVE OUTCOMES AS FA TECHNIQUES IN ADDITION TO SIGNIFICANTLY LOWER RADIATION EXPOSURE. MOREOVER, THERE IS NO STATISTICALLY SIGNIFICANT DIFFERENCE IN POSTOPERATIVE PROS BETWEEN RA AND FA. LONGER ANESTHESIA TIMES MAY ALSO BE ENCOUNTERED, AS IN THIS STUDY, WHICH IS LIKELY A RESULT OF MORE COMPLEX ROBOTIC SETUP AND WORKFLOW. REPORTED EVENT: FIFTY PATIENTS UNDERWENT ROBOT ASSISTED SPINE SURGERY. ONE PATIENT DEVELOPED PNEUMONIA WITHIN THIRTY DAYS FROM SURGERY. POST-OPERATIVE INFECTION OCCURRED IN ONE CASE RESULTING IN THE PATIENT HAVING TO RETURN TO THE OPERATING ROOM TO REMOVE THE HARDWARE. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT SOME SCREWS WERE REMOVED DUE TO INFECTION. NO ADVERSE EVENTS WERE RELATED 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": "" } ] }