{ "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": "3004142400-2025-00229", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251015", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20250922", "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": "20251015", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2858093", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20251015", "brand_name": "EXCELSIUS GPS", "generic_name": "ROBOT, SURGICAL, NAVIGATION UNIT", "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-0423", "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": "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": "LA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251114", "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": "20251015", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Life Threatening" ], "patient_age": "69 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Stroke/CVA", "Stroke/CVA" ] } ], "distributor_city": "", "date_report": "20251015", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "23301875", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250923", "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": "382625480", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. INVESTIGATION OF THE CASE LOGS SHOWED AN ACCURATE PATIENT REGISTRATION WITH NO MERGE SHIFTS OR PATIENT MOVEMENT. HOWEVER, IT WAS REPORTED THAT FOLLOWING CANNULA AND LEAD PLACEMENT AT A POSTERIOR TRAJECTORY THE PATIENT EXPERIENCED A STROKE. THEREFORE, THIS CASE WAS ABORTED AND THE PATIENT WAS IMMEDIATELY CLOSED AND TAKEN TO THE ER FOR FURTHER TREATMENT. FOLLOW UP WITH THE GLOBUS MEDICAL REPRESENTATIVE AT THIS CASE ON (B)(6) 2025 REVEALED NO IMPLANTS WERE MISPLACED OR INACCURATE FROM THE PLAN DURING THIS PROCEDURE. THE MEDIAL TRAJECTORY LEAD WAS REPORTEDLY MOVED 3MM MORE MEDIALLY WITHIN THE CASE JUST TO OBTAIN BETTER MER TESTING RESULTS AND NOT DUE TO THE ORIGINAL PLACEMENT BEING INACCURATE FROM PLAN. ADDITIONALLY, THE SURGEON IN THIS CASE DID NOT ATTRIBUTE THE PATIENT'S STROKE TO EGPS OR IMPLANTS PLACED USING EGPS. ULTIMATELY, THE MOST RECENT FOLLOW UP ON THE PATIENT'S CONDITION SHOWED THEY ARE STILL EXPERIENCING LEFT SIDED HEMIPARESIS AS A RESULT OF THE STROKE. THE CAUSE OF THE REPORTED ISSUE CAN BE TRACED TO USER TECHNIQUE." }, { "mdr_text_key": "382625481", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE CANNULA WAS INSERTED INTO THE CENTER TRAJECTORY, MER TESTING WAS PERFORMED. THE CANNULA WAS THEN MOVED TO THE MEDIAL TRAJECTORY. HOWEVER, RESULTS WERE NOT AS DESIRED AND THE TARGET WAS MOVED 3MM MEDIAL FROM THE ORIGINAL CENTER TRAJECTORY. THE LEAD WAS PLACED. DURING TESTING, IT WAS DECIDED TO MOVE THE CANNULA/LEAD TO THE POSTERIOR TRAJECTORY. AT THIS POINT, THE PATIENT APPEARED TO HAVE A STROKE AND THE PATIENT WAS CLOSED AND TAKEN TO THE ER. FOLLOW UP WITH THE SURGEON REVEALED THAT THERE WERE TWO BLEEDS UNILATERALLY ON THE RIGHT AT THE INTERNAL CAPSULE. THE SURGEON STATED THAT EVERY TRACK PLACED IS A 1% RISK OF THIS OCCURRING (4 TOTAL TRACKS ON RIGHT SIDE). THE LAST INFORMATION RECEIVED WAS THAT THEY WERE WAKING THE PATIENT UP, BUT IT IS UNKNOWN IF ANY DEFICITS ARE TEMPORARY AT THIS TIME." } ], "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": "" } ] }