{ "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": "3005075696-2026-00059", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20260225", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20260109", "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": "IS", "manufacturer_contact_area_code": "", "date_added": "20260225", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "503037", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260225", "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" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260429", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "30", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260225", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "71 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain" ] } ], "distributor_city": "", "date_report": "20260225", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "24446692", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260203", "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": "394017210", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AURON, M., BARKAY, G., EINAV, O., LANIADO, D., WEIL, Y., SCHROEDER, J. E. (2026). ROBOTIC-ASSISTED VERSUS FLUOROSCOPY-GUIDED SACROILIAC SCREW FIXATION: A RETROSPECTIVE COMPARATIVE STUDY. INJURY, 57(3), 113019. HTTPS://DOI.ORG/10.1016/J.INJURY.2026.113019 BACKGROUND: PERCUTANEOUS SACROILIAC (SI) SCREW FIXATION IS A WIDELY USED TECHNIQUE FOR STABILIZING SACRAL FRACTURES BUT IS CONSIDERED TECHNICALLY DEMANDING DUE TO COMPLEX PELVIC ANATOMY AND PROXIMITY TO NEUROVASCULAR STRUCTURES. CONVENTIONAL FLUOROSCOPY-GUIDED METHODS ARE ASSOCIATED WITH A RELATIVELY HIGH RISK OF SCREW MISPLACEMENT AND CONSIDERABLE RADIATION EXPOSURE TO PATIENTS AND STAFF. ROBOTIC-ASSISTED NAVIGATION SYSTEMS HAVE BEEN INTRODUCED TO ENHANCE SCREW ACCURACY AND REDUCE RADIATION EXPOSURE. THE AIM OF THIS STUDY WAS TO ASSESS THE EFFICIENCY, SAFETY, AND ACCURACY OF SACROILIAC SCREW FIXATION USING A ROBOT-ASSISTED METHOD COMPARED WITH A CONVENTIONAL FREEHAND TECHNIQUE. METHODS: MEDICAL RECORDS OF PATIENTS TREATED WITH SACROILIAC SCREW FIXATION FOR SACRAL FRACTURES AT A SINGLE LEVEL 1 TRAUMA CENTER BETWEEN DECEMBER 2014 AND AUGUST 2025 WERE RETROSPECTIVELY ANALYZED. PATIENTS WERE DIVIDED INTO ROBOTIC-ASSISTED AND FREEHAND FLUOROSCOPY-GUIDED GROUPS FOR COMPARATIVE ANALYSIS. PRIMARY OUTCOMES WERE INTRAOPERATIVE RADIATION EXPOSURE AND OPERATIVE TIME; SECONDARY OUTCOMES INCLUDED SCREW POSITION ACCURACY AND COMPLICATIONS. STATISTICAL ANALYSIS WAS PERFORMED WITH SIGNIFICANCE SET AT P 0.05. RESULTS: TWENTY-FIVE PATIENTS (MEAN AGE: 57.7 ± 22.4 YEARS) WERE INCLUDED; 15 IN THE ROBOTIC-ASSISTED AND 10 IN THE CONVENTIONAL FLU OROSCOPY-GUIDED GROUPS. A TOTAL OF 47 SI-SCREWS WERE INSERTED: 29 IN THE ROBOTIC GROUP AND 18 IN THE CONVENTIONAL GROUP. OPERATIVE TIMES WERE COMPARABLE BETWEEN GROUPS (47.1 ± 16.3 MIN AND. 45.1 ± 30.0 MIN, RESPECTIVELY; P = 0.85). COMPARED TO CONVENTIONAL FLUOROSCOPY, ROBOTIC ASSISTANCE WAS ASSOCIATED WITH REDUCED FLUOROSCOPY TIME (55.1 ± 23.1 VS. 181.1 ± 104.4 S, P=0.053) AND HIGHER SCREW PLACEMENT ACCURACY (94 % VS. 62 %, P = 0.06), ALTHOUGH THESE DID NOT REACH STATISTICAL SIGNIFICANCE. NO MAJOR INTRAOPERATIVE COMPLICATIONS OCCURRED. CONCLUSION: ROBOTIC-ASSISTED NAVIGATION IN SACROILIAC SCREW INSERTION CAN POTENTIALLY LOWER RADIATION EXPOSURE AND IMPROVE SCREW PLACEMENT ACCURACY COMPARED TO CONVENTIONAL TECHNIQUES, WITHOUT PROLONGING SURGICAL TIME. THESE FINDINGS SUPPORT ROBOTIC GUIDANCE AS A SAFE AND POTENTIALLY MORE PRECISE ALTERNATIVE FOR SACRAL FRACTURE FIXATION. FURTHER PROSPECTIVE STUDIES SHOULD BE PERFORMED TO EVALUATE THE POSSIBLE BENEFITS OF ROBOTIC ASSISTED SACROILIAC SCREW FIXATION. REPORTED EVENT: FIFTEEN PATIENTS UNDERWENT PERCUTANEOUS SACRO-ILIAC SCREW FIXATION TO ADDRESS UNILATERAL OR BILATERAL SACRAL FRACTURES. TWO PATIENTS UNDERWENT SCREW REMOVAL. ONE WAS DUE TO A SCREW BACK OUT THAT PROVIDED INSUFFICIENT FRACTURE FIXATION. THIS PATIENT WAS ASYMPTOMATIC AND THE SCREW WAS ACCURATE. THE OTHER SCREW REMOVAL WAS DUE TO RADICULAR PAIN. THE SCREW WAS FOUND TO BE IN CONTACT WITH THE CORTICAL BONE, BUT WAS COMPLETELY INTRAOSSEOUS. IN TOTAL ONE SCREW WAS IN CONTACT WITH THE CORTICAL BONE, ONE SCREW HAD A CORTICAL BREACH OF LESS THAN TWO MILLIMETERS, ONE SCREW HAD A CORTICAL BREACH BETWEEN TWO TO FOUR MILLIMETERS, AND ONE SCREW BREACHED OVER FOUR MILLIMETERS. SEE ATTACHED LITERATURE ARTICLE." }, { "mdr_text_key": "394017211", "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 NOT PROVIDED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS AVAILABLE ONLINE 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. 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." } ], "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": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }