{ "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": "3005075696-2025-00367", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20251024", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20250301", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "IN", "manufacturer_contact_area_code": "763", "date_added": "20251024", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "134291", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251024", "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": "20251114", "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": "20251024", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "53 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Muscle Weakness/Atrophy", "Spinal Column Injury", "Post Operative Wound Infection", "Muscle Weakness/Atrophy", "Spinal Column Injury", "Post Operative Wound Infection" ] } ], "distributor_city": "", "date_report": "20251024", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "23384872", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20251001", "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": "383478925", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A1-A5) PATIENT INFORMATION WAS INCLUDED IN THE ARTICLE. 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. A1) PATIENT IDENTIFIER(S) WAS NOT INCLUDED IN THE ARTICLE. B3) PLEASE NOTE THAT THIS DATE IS BASED OFF THE EARLIEST DATE PROVIDED REGARDING THE PROCEDURES THAT TOOK PLACE IN THIS ARTICLE. B5) INCLUDED THE ARTICLE CITATION. D4) THE SYSTEM SERIAL NUMBER WAS NOT PROVIDED IN THE JOURNAL ARTICLE. H2) MULTIPLE ANNEX E CODES WERE APPLIED. SEE CLARIFICATION BELOW: E1621 - TRANSIENT C5 WEAKNESS E2115 - SUPERFICIAL WOUND INFECTIONS; DEEP INFECTION E1631 - SINGLE VERTEBRAL ARTERY INJURY 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." }, { "mdr_text_key": "383478926", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "CITATION: SONI, ABHISHEK, ET AL. ¿ROBOT-ASSISTED CERVICAL PEDICLE SCREW PLACEMENT USING A NOVEL HYBRID DILATOR TECHNIQUE: A CLINICAL SERIES OF 565 SCREWS.¿ JOURNAL OF CRANIOVERTEBRAL JUNCTION AND SPINE, VOL. 16, NO. 3, 18 SEPT. 2025, PP. 301¿306, HTTPS://DOI.ORG/1 0.4103/JCVJS.JCVJS_115_25. ABSTRACT BACKGROUND: CERVICAL PEDICLE SCREWS PROVIDE SUPERIOR BIOMECHANICAL FIXATION WITH PULLOUT STRENGTH FOUR TIMES GREATER THAN LATERAL MASS SCREWS, BUT PLACEMENT IS TECHNICALLY DEMANDING WITH TRADITIONAL MALPOSITION RATES OF 6.7%¿31.6%. ROBOTIC-ASSISTED SPINE SURGERY HAS DEMONSTRATED SUCCESS IN THORACOLUMBAR APPLICATIONS, BUT CERVICAL TRANSLATION HAS BEEN HINDERED BY THE LACK OF CERVICAL-SPECIFIC I NSTRUMENTATION REQUIRING EXPENSIVE CUSTOM INSTRUMENTS. METHODS: WE DEVELOPED A HYBRID TECHNIQUE COMBINING ROBOTIC GUIDANCE WITH STANDARD CERVICAL INSTRUMENTATION USING MINIMALLY INVASIVE SURGERY DILATORS AS AN INTERFACE. SIXTY-FIVE CONSECUTIVE PATIENTS UNDERWENT ROBOT-ASSISTED CERVICAL PEDICLE SCREW PLACEMENT WITH 565 SCREWS ACROSS C2¿C7 LEVELS USING MAZORX STEALTH ROBOTIC SYSTEM WITH O-ARM NAVIGATION. ACCURACY WAS ASSESSED USING GERTZBEIN-ROBBINS AND NEO CLASSIFICATION SYSTEMS WITH 3¿6-MONTH FOLLOW-UP FOR COMPLICATIONS. RESULTS: THE TECHNIQUE ACHIEVED 98.76% CLINICALLY ACCEPTABLE ACCURACY (GERTZBEIN-ROBBINS GRADE A + B) WITH 1.24% BREACH RATE. PERFECT PLACEMENT (GRADE A) OCCURRED IN 95.22% OF SCREWS. VERTEBRAL ARTERY PROTECTION WAS EXCELLENT WITH 99.65% SHOWING NO FORAMEN BREACH. MAJOR COMPLICATIONS OCCURRED IN 1.5% OF PATIENTS (SINGLE VERTEBRAL ARTERY INJURY), WITH 7.7% EXPERIENCING TRANSIENT C5 WEAKNESS THAT RESOLVED COMPLETELY. NO PATIENTS REQUIRED REVISION SURGERY. CONCLUSIONS: THIS HYBRID TECHNIQUE ADDRESSES INSTRUMENT COMPATIBILITY BARRIERS IN ROBOTIC CERVICAL SPINE SURGERY BY ELIMINATING DEPENDENCE ON CUSTOM INSTRUMENTS WHILE MAINTAINING ROBOTIC ACCURACY. THE TECHNIQUE DEMONSTRATES SUPERIOR OUTCOMES COMPARED TO TRADITIONAL APPROACHES AND FACILITATES BROADER ROBOTIC CERVICAL SURGERY ADOPTION. MULTI-CENTER VALIDATION STUDIES ARE NEEDED TO ESTABLISH THE GENERALIZABILITY. REPORTABLE EVENTS: 29 OUT OF 565 SCREWS WERE REPORTED TO HAVE BEEN INACCURATE. 20 SCREWS SHOWED MINOR CORTICAL CONTACT WITHOUT PENETRATION (MILLIMETER (MM) ACCURACY AMOUNT NOT PROVIDED), SEVEN SCREWS DEMONSTRATED CORTICAL BREACH (2 MM), AND TWO SCREWS DEMONSTRATED FORAMEN BREACH (2 MM). ONE PATIENT EXPERIENCED A VERTEBRAL ARTERY INJURY IN A NONDOMINANT VESSEL. THIS WAS SUCCESSFULLY MANAGED WITH BONE WAX PACKING WITHOUT LASTING SEQUELAE. FIVE PATIENTS EXPERIENCED TRANSIENT C5 NERVE WEAKNESS WITH COMPLETE RESOLUTION IN ALL CASES. FOUR PATIENTS EXPERIENCES A SUPERFICIAL WOUND INFECTION AND WERE TREATED WITH ORAL ANTIBIOTICS. ONE PATIENT EXPERIENCED A DEEP WOUND INFECTION AND OUTPATIENT TREATMENT AND ANTIBIOTICS WERE USED AS TREATMENT. 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": "" } ] }