{ "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": "3005075696-2024-00103", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20240808", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20240612", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "IN", "manufacturer_contact_area_code": "763", "date_added": "20240808", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2398017", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240808", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250820", "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": "20240808", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "51 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Post Operative Wound Infection", "Post Operative Wound Infection" ] } ], "distributor_city": "", "date_report": "20240808", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "19942080", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240715", "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": "348825843", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "CITATION: SRINIVASA, V., THIRUGNANAM, B., PAI KANHANGAD, M., SONI, A., KASHYAP, A., VIDYADHARA, A., & RAO, S. K. (2024). FLATTENING THE LEARNING CURVE ¿ EARLY EXPERIENCE OF ROBOTIC-ASSISTED PEDICLE SCREW PLACEMENT IN SPINE SURGERY. JOURNAL OF ORTHOPAEDICS, 57, 49¿54. HTTPS://DOI.ORG/10.1016/J.JOR.2024.06.011. SUMMARY: AIMS AND OBJECTIVES: TO DETERMINE ACCURACY OF PEDICLE SCREWS PLACED BY FREEHAND, FLUOROSCOPY-ASSISTANCE AND ROBOTIC-ASSISTANCE WITH INTRAOPERATIVE IMAGE ACQUISITION, AND DETERMINE THE PRESENCE OF LEARNING CURVE IN ROBOTIC SPINE SURGERY IN A PROSPECTIVE SINGLE CENTRE STUDY. MATERIALS AND METHODS: IN A PROSPECTIVE STUDY, A TOTAL OF 1120 PEDICLE SCREWS WERE PLACED IN FREEHAND GROUP (N = 175), 1250 SCREWS WERE PLACED IN FLUOROSCOPY ASSISTED GROUP (N = 172), AND 1225 SCREWS WERE INSERTED IN ROBOTIC-ASSISTED GROUP(N = 180). SURGICAL PARAMETERS AND SCREW ACCURACY WERE ANALYZED BETWEEN THE THREE GROUPS. THE PREOPERATIVE PLAN WAS OVERLAPPED WITH POST OPERATIVE O-ARM SCAN TO DETERMINE IF THE SCREWS WERE EXECUTED AS PLANNED. RESULTS: THE FREQUENCY OF CLINICALLY ACCEPTABLE SCREW PLACEMENT (GERTZBEIN AND ROBBINS GRADE A, B) IN THE FREEHAND, FLUOROSCOPY-ASSISTED, AND ROBOTIC-ASSISTED GROUPS WERE 97.7 %, 98.6 %, AND 99.34 % RESPECTIVELY. HIGHER PEDICLE SCREW ACCURACY, AND LOWER BLOOD LOSS WERE SEEN WITH ROBOTIC ASSISTANCE. THERE WAS NO SIGNIFICANT DIFFERENCE IN THESE PARAMETERS BETWEEN SURGERIES COMMENCING BEFORE AND AFTER 2 P.M. WE FOUND NO STATISTICALLY SIGNIFICANT DIFFERENCES BETWEEN THE PLANNED AND EXECUTED SCREW TRAJECTORIES IN ROBOTIC ASSISTED GROUP IRRESPECTIVE OF SURGICAL EXPERIENCE. CONCLUSION: THE THIRD-GENERATION ROBOTIC-ASSISTED PEDICLE SCREW PLACEMENT SYSTEM, USED IN CONJUNCTION WITH INTRAOPERATIVE 3D O-ARM IMAGING, CONSISTENTLY LOWERED BLOOD LOSS AND INCREASED ACCURACY OF PEDICLE SCREW PLACEMENT IN THE THORACOLUMBAR SPINE. IT ALSO HAS EASY ADAPTABILITY INTO SPINE PRACTICE WITH MINIMAL LEARNING CURVE. REPORTED EVENTS ONE HUNDRED AND EIGHTY PATIENTS UNDERWENT ROBOT-ASSISTED SPINE SURGERY. IT WAS FOUND THAT EIGHT SCREWS HAD PEDICLE BREACHES AND WERE DEVIATED OVER TWO MILLIMETERS. THE SCREWS WERE REVISED. FOUR PATIENTS HAD A POST OPERATIVE WOUND INFECTIONS. IT WAS NOTED THESE WOULD INFECTIONS COULD HAVE BEEN SUPERFICIAL OR THERE IS THE POSSIBILITY THAT TWO OF THESE PATIENTS NEEDED SURGICAL RE-EXPLORATION DUE TO A DEEP INFECTION." }, { "mdr_text_key": "348825844", "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. 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. 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": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }