{ "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": "3004142400-2025-00007", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250102", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20241210", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "19403", "reporter_occupation_code": "003", "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": "20250102", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1332278", "implant_date_year": "2024", "date_removed_year": "2024", "serviced_by_3rd_party_flag": "U", "date_received": "20250102", "brand_name": "EXCELSIUS ROBOTICS SYSTEM", "generic_name": "SYSTEM, EXCELSIUS GPS, 120V", "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": "GPS-0306", "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": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/17/2024", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250822", "health_professional": "", "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": "20250102", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "18 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "Hispanic", "patient_race": "", "patient_problems": [ "Spinal Column Injury", "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20250130", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "21054575", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20241217", "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": "360359364", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE CASE LOGS HAVE NOT BEEN VALUATED FOR REVIEW. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE." }, { "mdr_text_key": "360359365", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED. THIS EVENT OCCURRED IN SPAIN." }, { "mdr_text_key": "363362604", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED. THIS EVENT OCCURRED IN SPAIN." }, { "mdr_text_key": "363362605", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "OUR INVESTIGATION REVEALED THAT THE MISPLACED IMPLANTS WERE LIKELY THE RESULT OF A DYNAMIC REFERENCE BASE (DRB) SHIFT WHILE UTILIZING EXCELSIUS GPS FOR NAVIGATION. THE CASE LOGS INDICATED THAT THE SYSTEM DID NOT DETECT NOR ALERT THE USER OF ANY POTENTIAL DRB SHIFTS WHILE NAVIGATING IMPLANTS. THE SURVEILLANCE MARKER (SM) WAS PAIRED BEFORE THE ACQUISITION OF ANY SCANS OR IMAGES; HOWEVER, IT WAS CLEARED PRIOR TO PROCEEDING TO THE NAVIGATE PAGE FOR THE FIRST TIME DURING THE PROCEDURE. IT IS RECOMMENDED THAT THE SM BE PAIRED THROUGHOUT THE DURATION OF THE CASE SO THAT THE SYSTEM CAN ALERT THE USER TO ANY SHIFTS. IN THIS INSTANCE, THE SM WAS NOT PAIRED THROUGHOUT THE DURATION OF THE CASE SO THE USER LIKELY EXPERIENCED A DRB SHIFT BEFORE THE PLACEMENT OF ANY IMPLANTS CAUSING ALL TRAJECTORIES TO SHIFT IN A SIMILAR PATTERN. DRB SHIFTS CAN CAUSE NAVIGATIONAL INTEGRITY ISSUES AND CAN LEAD TO THE MISPLACEMENT OF IMPLANTS. THE USER ACKNOWLEDGES THAT THEY WILL PERFORM AN ANATOMICAL LANDMARK CHECK WITH EACH NEW INSTRUMENT OR LEVEL TO ENSURE NAVIGATIONAL INTEGRITY BEFORE PROCEEDING WITH NAVIGATION. IF THE ANATOMICAL LANDMARK CHECK IS INACCURATE, THE USER CAN REREGISTER VIA THE \"LIFE-SAVER\" OR \"BAIL OUT\" BUTTON. THE OBSERVED OVERALL RISK IS LOW, WHICH MATCHES THE OBSERVED ANTICIPATED RISK LEVEL; THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED." } ], "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": "01/30/2025" } ] }