{ "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": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MR.", "manufacturer_contact_state": "PA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "AUDUBON", "manufacturer_contact_address_1": "2560 GENERAL ARMISTEAD AVENUE", "manufacturer_contact_pcity": "61093018", "event_type": "Injury", "report_number": "3004142400-2025-00268", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251028", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20250703", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "19403", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "6109301800", "noe_summarized": "1", "manufacturer_contact_l_name": "PAUL", "source_type": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "19403", "manufacturer_g1_state": "PA", "reporter_country_code": "US", "manufacturer_contact_area_code": "610", "date_added": "20251028", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2485760", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20251028", "brand_name": "EXCELSIUS GPS", "generic_name": "ROBOTIC SURGICAL NAVIGATION SYSTEM", "manufacturer_d_name": "GLOBUS MEDICAL, INC.", "manufacturer_d_address_1": "2560 GENERAL ARMISTEAD AVENUE", "manufacturer_d_address_2": "", "manufacturer_d_city": "AUDUBON", "manufacturer_d_state": "PA", "manufacturer_d_zip_code": "19403", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "19403", "device_operator": "HEALTH PROFESSIONAL", "model_number": "6143.1001", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00889095481297", "udi_public": "00889095481297", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Human-Device Interface Problem", "Human-Device Interface Problem" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/07/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260519", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6109", "patient": [ { "patient_sequence_number": "1", "date_received": "20251028", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20251121", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "23407578", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250707", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "19403", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "GLOBUS MEDICAL, INC.", "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": "394316644", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ENGINEERING EVALUATION WAS UNABLE TO DETERMINE A ROOT CAUSE DUE TO INSUFFICIENT INFORMATION. THE USER DID NOT SUBMIT CASE LOGS FOR INVESTIGATION. HOWEVER, IT WAS REPORTED THAT HIGH DEFLECTION WAS DETECTED BY THE SYSTEM AND ALERTED TO THE USER WHILE DRILLING ON TRAJECTORY \"J.\" HIGH DEFLECTION FORCES INDICATE SKIVING WHICH CAN LEAD TO NAVIGATIONAL INACCURACIES OR MISPLACED IMPLANTS. ADDITIONALLY, TRAJECTORIES \"I\" AND \"K\" WERE REPORTED AS BEING PLACED FROM THEIR RESPECTIVE PLANS. IT WAS NOT SPECIFICALLY REPORTED IF THERE WAS HIGH DEFLECTION EXPERIENCED DURING THOSE \"I\" AND \"K\" TRAJECTORIES; HOWEVER, THE USER REPORTED SUCCESSFUL ANATOMICAL LANDMARK CHECKS AFTER REGISTRATION. MISPLACED IMPLANTS WITH ACCURATE ANATOMICAL LANDMARK CHECKS ARE ALSO SYMPTOMATIC OF SKIVING ULTIMATELY, ONLY THE CRANIAL BOLT FOR TRAJECTORY \"J\" WAS RE-POSITIONED INTRA-OPERATIVELY AND THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT. THE SEVERITY OBSERVED DID NOT EXCEED THE ANTICIPATED SEVERITY. THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH MATCHES THE OBSERVED ANTICIPATED RISK LEVEL; THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED AND THERE IS NO FURTHER INVESTIGATION REQUIRED. THE FOLLOWING SECTIONS WERE UPDATED FOR THIS SUPPLEMENTAL REPORT. B4, B6, G6, H2, H3, H10." }, { "mdr_text_key": "394316645", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THERE WAS A RADIAL ERROR >1.5MM AT ENTRY FOR I' J'AND K'. DEFLECTION VERBALIZED BY CSR DURING DRILLING. J' DRILL BIT WAS RE-DRILL AND REPOSITIONED ONE TIME." }, { "mdr_text_key": "383676423", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THERE WAS A RADIAL ERROR >1.5MM AT ENTRY FOR I' J'AND K'. DEFLECTION VERBALIZED BY CSR DURING DRILLING. J' DRILL BIT WAS RE-DRILL AND REPOSITIONED ONE TIME." }, { "mdr_text_key": "383676424", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE WAS UNAVAILABLE FOR EVALUATION. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "2560 GENERAL ARMISTEAD AVENUE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "19403", "manufacturer_contact_exchange": "610", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "11/21/2025" } ] }