{ "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": "3005075696-2025-00231", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250324", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20250201", "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": "20250324", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1579198", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250324", "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": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250811", "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": "20250324", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " R" ], "patient_age": "14 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Post Operative Wound Infection", "Hemorrhage/Blood Loss/Bleeding", "Post Operative Wound Infection" ] } ], "distributor_city": "", "date_report": "20250324", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "21678416", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250305", "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": "366497816", "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 PUBLISHED 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. H.6. MULTIPLE PATIENT CODES WERE APPLIED. BELOW LISTED WHAT EACH CORRELATES TO. E2115 - INFECTION E0506 - BLOOD LOSS 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": "366497817", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "BIRCH, C., WELCH, N., COOK, D., HEDEQUIST, D. (2025). INSTRUMENTATION USING ROBOTICS COUPLED WITH NAVIGATION IN PEDIATRIC SP INE DEFORMITY SURGERY: A TECHNICAL REPORT OF SACROPELVIC INSTRUMENTATION. SPINE DEFORMITY. HTTPS://DOI.ORG/10.1007/S43390-025-01047-6. PURPOSE: THIS TECHNICAL REPORT PRESENTS THE INTRAOPERATIVE EXPERIENCE OF USING ROBOTIC ASSISTED NAVIGATION (RAN) FOR SACRO-PELVIC INSTRUMENTATION IN PEDIATRIC SPINE DEFORMITY SURGERY. METHODS: A RETROSPECTIVE REVIEW OF PATIENTS WHO UNDERWENT SURGERY USING RAN FOR SACROPELVIC INSTRUMENTATION AT A SINGLE INSTITUTION FROM 2019 TO 2022 WAS CONDUCTED. IN CASES WITH SCREW CONFIRMATION IMAGING, SCREWS WERE EVALUATED USING THE GERTZBEIN AND ROBBINS CLASSIFICATION SCALE. RESULTS: 52 CASES WERE INCLUDED. AVERAGE AGE AT SURGERY WAS 14.1 YEARS AND 67.3% OF PATIENTS WERE FEMALE. THE MOST COMMON DIAGNOSIS WAS SPONDYLOLISTHESIS (48.1%). THE AVERAGE MAJOR CURVE IN SCOLIOSIS CASES WAS 77°. A SCHANZ PIN IN THE POSTERIOR SUPERIOR ILIAC SPINE WAS PLACED IN 98.1% OF SURGERIES COMPARED TO 1 CASE WITH A SPINOUS PROCESS CLAMP. INTRAOPERATIVE 3D IMAGING SCANS (SCAN/PLAN) WERE USED FOR 69.2% OF THE ROBOTIC REGISTRATIONS TO THE PATIENT AND INTRAOPERATIVE FLUOROSCOPY¿CT SCANS WERE USED FOR 30.8%.644 TOTAL SCREWS WERE PLACED, WITH 427 PLACED ROBOTICALLY. SPECIFICALLY, IN THE SACRAL-PELVIC REGION, 98 S1, 18 S2, 58 S2AI, AND 5 ILIAC SCREWS WERE PLACED USING RAN (179 SCREWS). IN 17 CASES WITH 139 TOTAL ROBOTIC SCREWS, POST-INSTRUMENTATION INTRAOPERATIVE 3D IMAGING OR POSTOPERATIVE CT SCANS WERE OBTAINED. OF THESE SCREWS, 99.3% (138/139; 95% CI=95.5¿99.96) WERE PLACED ACCURATELY (GRADE A OR GRADE B). ONE S2AI SCREW HAD AN ANTERIOR BREACH ON INTRAOPERATIVE 3D IMAGING SCAN AND WAS CHANGED PRIOR TO CLOSURE. LOSS OF RAN REGISTRATION WAS OBSERVED IN 2 CASES (3.8%). NO CASES REQUIRED RETURN TO THE OPERATING ROOM FOR SCREW MALPOSITION. CONCLUSION: THIS STUDY HIGHLIGHTS HIGH SCREW ACCURACY WITH NO NEUROLOGIC COMPROMISE ASSOCIATED WITH THE USE OF RAN TECHNOLOGY. REPORTED EVENTS FIFTY-TWO PATIENTS UNDERWENT ROBOTIC ASSISTED NAVIGATION (RAN) SURGERY TO ADDRESS PEDIATRIC SPINE DEFORMITIES. SIX HUNDRED FORTY-FOUR SCREWS WERE EXECUTED, WHERE FOUR HUNDRED TWENTY-SEVEN WERE PLACED USING THE RAN TECHNIQUE. THE OTHER SCREWS WERE PLACED FREEHAND BASED ON THE SURGEON'S PREFERENCE. ONE PELVIC SCREW WAS PLANNED ON RAN WAS FOUND TO EXTEND BEYOND THE CORTEX ON INTRAOPERATIVE FLUORO. THE SCREW WAS REMOVED AND REPLACED WITH A SCREW THAT WAS FIVE MILLIMETERS SHORTER. ONE S2AI SCREW WAS FOUND TO HAVE AN ANTERIOR CORTICAL BREACH AND WAS SUBSEQUENTLY REDIRECTED. COMPLICATIONS WERE NOTED. IN FIVE CASES THERE WAS INFECTION, THREE SUBFASCIAL AND TWO SUPERFICIAL INFECTIONS. ALL FIVE PATIENTS UNDERWENT EARLY REPEAT SURGICAL INTERVENTION WITHIN THIRTY DAYS FOR WOUND EXPLORATION WITH THE INDICATION OF ONGOING DRAINAGE FROM THE INCISION. IN ALL FIVE CASE, ANTIBIOTICS WERE ADMINISTERED WITH SUCCESSFUL IMPLANT RETENTION. FINALLY, IN ONE CASE THE PATIENT EXPERIENCED SIGNIFICANT BLOOD LOSS, WITH TWO THOUSAND SIX HUNDRED MILLILITERS OF BLOOD LOSS." } ], "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": "" } ] }