{ "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": "3005075696-2024-00125", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20240919", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20240729", "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": "20240919", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1671445", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240919", "brand_name": "MAZOR X SYSTEM", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAZOR ROBOTICS LTD", "manufacturer_d_address_1": "1 HAESHEL STREET. 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K., NARENDRAN, N., SKAGGS, D. L., TUCHMAN, A., WALKER, C. T., & PERRY, T. G. (2024). COMPARISON OF ROSTRAL FACET JOINT VIOLATIONS IN ROBOTIC- AND NAVIGATION-ASSISTED PEDICLE SCREW PLACEMENT FOR ADULT LUMBAR SPINE INSTRUMENTATION. THE SPINE JOURNAL. HTTPS://DOI.ORG/10.1016/J.SPINEE.2024.07.008 SUMMARY: BACKGROUND CONTEXT: FACET JOINT VIOLATION BY PEDICLE SCREWS MAY LEAD TO ADJACENT-SEGMENT DISEASE AND POSTOPERATIVE PAIN. PREVIOUS STUDIES HAVE REPORTED THE INCIDENCE OF ROSTRAL FACET JOINT VIOLATION USING VARIOUS PEDICLE SCREW INSERTION TECHNIQUES. HOWEVER, THE INCIDENCE OF FACET JOINT VIOLATIONS WITH ROBOTIC GUIDANCE HAS NOT BEEN DETERMINED. PURPOSE: TO INVESTIGATE AND COMPARE THE INCIDENCE OF ROSTRAL FACET JOINT VIOLATION BY PEDICLE SCREWS UNDER ROBOTIC GUIDANCE AND COMPUTERIZED TOMOGRAPHY (CT) NAVIGATION GUIDANCE. STUDY DESIGN/SETTING: RETROSPECTIVE MATCHED COHORT. PATIENT SAMPLE: ALL PATIENTS WHO UNDERWENT ROBOTIC-ASSISTED LUMBAR FUSION AT A MAJOR SPINE CENTER UP UNTIL 2023 WERE RETROSPECTIVELY IDENTIFIED AND MATCHED 1:3 TO PATIENTS UNDERGOING CT NAVIGATION GUIDANCE BASED BY ON AGE, SEX, ROSTRAL VERTEBRAL LEVEL, AND LENGTH OF CONSTRUCT. INCLUSION CRITERIA CONSISTED OF AGE GREATER THAN 18 YEARS, BILATERAL PEDICLE SCREW FIXATION, AND PRESENCE OF A POSTOPERATIVE CT SCAN OF THE LUMBAR SPINE OR ABDOMEN/PELVIS AT ANY POINT IN THE POST-OPERATIVE PERIOD. OUTCOME MEASURES: ROSTRAL FACET JOINT VIOLATIONS. METHODS: DESCRIPTIVE STATISTICS WERE USED TO COMPARE COHORTS: FREQUENCIES, CHI-SQUARED ANALYSIS FOR CATEGORICAL VARIABLES, AND T-TEST FOR CONTINUOUS VARIABLES. RESULTS: A TOTAL OF 408 ROSTRAL PEDICLE SCREWS WERE IMPLANTED IN 204 PATIENTS (ROBOT: 102; NAVIGATION: 306). OVERALL, 13 (12.3%) ROSTRAL FACET JOINT VIOLATIONS WERE OBSERVED IN THE ROBOT COHORT AND 75 (24.5%) IN THE NAVIGATION COHORT (P=.01). SPECIFICALLY, FEWER ROBOTIC VIOLATIONS WERE OBSERVED AT THE L2 (3.5% VS. 32.1%, P=.003) AND L3 LEVELS (3.9% VS. 18.1%, P=.08) COMPARED TO NAVIGATION. NO DIFFERENCE WAS OBSERVED AT L4 AND L5. BILATERAL VIOLATIONS ARE SIGNIFICANTLY REDUCED WITH ROBOTIC APPROACHES (5.3% VS. 14.4%, P=.03). LASTLY, MORE FACET JOINT VIOLATIONS WERE OBSERVED DURING OPEN APPROACHES (ROBOT: 18.8%, NAVIGATION: 27.3%) THAN PERCUTANEOUS APPROACHES (ROBOT: 11.6%, NAVIGATION: 7.1%) IN BOTH GROUPS (P<(><<)>.001). THE RATE OF L4 FACET VIOLATIONS WAS 18.8% IN THE ROBOTIC COHORT AND 27.3% IN THE NAVIGATION COHORT. THE RATE OF L5 FACET VIOLATIONS WAS 31.3% IN THE ROBOTIC COHORT AND 29.2% IN THE NAVIGATION C OHORT. CONCLUSIONS: USE OF ROBOTIC ASSISTANCE IN LUMBAR PEDICLE SCREWS SIGNIFICANTLY REDUCED THE RATE OF ROSTRAL FACET JOINT VIOLATIONS COM PARED TO NAVIGATION GUIDANCE AT L2 AND L3 LEVELS, BUT NOT AT L4 AND L5, WITH FACET VIOLATIONS APPROACHING NEARLY ONE-THIRD OF THE PATIENTS AT L5 SCREWS. ROSTRAL FACET VIOLATIONS CAN PLAY A SIGNIFICANT ROLE IN ADJACENT SEGMENT DEGENERATION AND DISEASE. TECHNICAL FACTORS AND TRAJECTORY ISSUES LIKELY PLAY A ROLE AND ADDRESSING THESE COMPONENTS SHOULD MINIMIZE UNINTENDED FACET VIOLATION AND PROXIMAL ADDING ON. REPORTED EVENTS: 51 PATIENTS UNDERWENT A ROBOTIC ASSISTED LUMBAR FUSION TO ADDRESS VARIOUS SPINAL ISSUES. IT WAS REPORTED THAT 13 PATIENTS EXPERIENCED ROSTRAL FACET JOINT VIOLATIONS. A TOTAL OF 102 ROBOTIC ASSISTED SCREWS WERE PLACED AND 13 ROBOTIC ASSISTED SCREWS HAD FACET JOINT VIOLATIONS. THE FOLLOWING GRADING WAS AS FOLLOWS: GRADE 1: SCREW ABUTTING THE LATERAL FACET. GRADE 2: SCREW CLEARLY WITHIN THE ARTICULAR FACET JOINT. GRADE 3: THE SCREW HEAD WAS CLEARLY WITHIN THE ARTICULAR FACET JOINT. 6 SCREWS HAD A GRADE 1 FACET JOINT VIOLATION. 2 SCREWS HAD A GRADE 2 FACET JOINT VIOLATION. 5 SCREWS HAD A GRADE 3 FACET JOINT VIOLATION. OF THE SCREWS PLACED IN THE UPPER INSTRUMENTED LEVEL, LEVEL L2 HAD 1 OF 28 SCREWS WITH A FACET JOINT VIOLATION, LEVEL L3 HAD 1 OF 26 SCREWS WITH A FACET JOINT VIOLATION, LEVEL L4 HAD 6 OF 32 SCREWS WITH A FACET JOINT VIOLATION, AND LEVEL L5 HAD 5 OF 16 SCREWS WITH A FACET JOINT VIOLATION. SEE ATTACHED LITERATURE ARTICLE." }, { "mdr_text_key": "352164787", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A1-A5) PATIENT INFORMATION WAS INCLUDED IN THE JOURNAL. A2) THIS VALUE REPRESENTS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A3) THIS VALUE REPRESENTS THE MAJORITY SEX OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A4) THE WEIGHT OF THE PATIENTS WAS NOT PROVIDED. B3) PLEASE NOTE THAT THIS DATE IS BASED OFF THE ACCEPTED PUBLICATION DATE OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THIS PUBLISHED LITERATURE, B5) INCLUDED THE ARTICLE CITATION. D4) THE SYSTEM SERIAL NUMBER WAS NOT PROVIDED IN THE JOURNAL ARTICLE. H3, H6) NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. H4) 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": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }