{ "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": "3004142400-2024-00305", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20241230", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20241129", "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": "20241230", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2227350", "implant_date_year": "2024", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20241230", "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-0526", "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": "12/02/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250825", "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": "20241230", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "54 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20240128", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "21038593", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20241202", "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": "363349352", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ROBOTIC ERROR, AND SCREWS WERE THEN PLACED WITHOUT ROBOT." }, { "mdr_text_key": "363349353", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "OUR EVALUATION OF THE MISPLACED IMPLANTS WAS INCONCLUSIVE DUE TO NO USABLE CASE LOGS FROM THE PROCEDURE BEING PROVIDED TO THE APPLICATIONS TEAM DESPITE MULTIPLE ATTEMPTS TO OBTAIN THEM. THE DESCRIPTION PROVIDED WITHIN THE EVENT EVALUATION FORM STATED THAT THE USER WAS INITIALLY UNABLE TO OBTAIN AN ACCEPTABLE PRE-OPERATIVE REGISTRATION. THE USER STATED THAT THE REGISTRATION THAT WAS CREATED CONTAINED SHIFTS IN THE AP AND LATERAL VIEWS AND INCLUDED A SHIFT IN THE PLACED CENTROIDS IN THE SOFTWARE. THIS SHIFT IS LIKELY THE RESULT OF TRACKING ERRORS RESULTING FROM MOVEMENT DURING FLUOROSCOPIC IMAGE ACQUISITION. THE USER STATED THAT THEY AGAIN PERFORMED THE MERGE AFTER ACQUIRING NEW FLUOROSCOPY IMAGES AND WAS SUCCESSFUL. THIS PRE-OPERATIVE REGISTRATION CAUSED A NAVIGATIONAL INTEGRITY ISSUE AND THE USER OPTED TO ABORT THE USE OF EXCELSIUSGPS FOR TRADITIONAL TECHNIQUES. IT IS RECOMMENDED THAT THE SURVEILLANCE MARKER (SM) BE PAIRED BEFORE THE ACQUISITION OF ANY FLUOROSCOPY SHOTS OR SCANS SO THAT THE SYSTEM CAN ALERT THE USER TO ANY SHIFTS OR MOVEMENT DURING FLUOROSCOPY ACQUISITION. ANY MOVEMENT DURING IMAGE ACQUISITION OR A DYNAMIC REFERENCE BASE (DRB) SHIFT CAN CAUSE NAVIGATIONAL INTEGRITY ISSUES AND CAN POTENTIALLY 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." }, { "mdr_text_key": "360263304", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE CASE LOGS HAVE NOT BEEN REVIEWED FOR EVALUATION. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE." }, { "mdr_text_key": "360263305", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ROBOTIC ERROR, AND SCREWS WERE THEN PLACED WITHOUT ROBOT." } ], "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": "01/29/2025" } ] }