{ "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": "3004142400-2025-00109", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250516", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20250421", "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": "20250516", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1467800", "implant_date_year": "2025", "date_removed_year": "2025", "serviced_by_3rd_party_flag": "U", "date_received": "20250516", "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-0168", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00088909548129", "udi_public": "0088909548129", "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": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250826", "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": "20250516", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "23 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hematoma", "Hemorrhage/Blood Loss/Bleeding", "Hematoma", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20250512", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "22037467", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250421", "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": "370470368", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO DEVICE MALFUNCTION. THE CASE LOGS SHOWED ALL 4 LEADS FROM THIS PROCEDURE WERE PLACED ANTERIORLY IN THE SAME DIRECTION FROM THEIR PLANNED TRAJECTORY. ALL IMPLANTS BEING MISPLACED FROM THE PLAN IN THE SAME DIRECTION IS INDICATIVE OF A PATIENT REFERENCE OR DRB SHIFT. HOWEVER, DURING IMPLANTATION THE SURGEON ALSO NOTICED ABNORMAL BLEEDING DUE TO THE PATIENT EXPERIENCING A SUBDURAL HEMATOMA. THE CASE WAS THEREFORE ABORTED AS THE PATIENT UNDERWENT HEMATOMA EVACUATION PROCEDURE. 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. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE." }, { "mdr_text_key": "370470369", "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 AFTER BLEEDING WAS NOTICED. SHORTLY AFTER, THE PATIENT DISPLAYED SUSPECTED PRESENCE OF STROKE AND/OR HEMATOMA." } ], "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": "" } ] }