{ "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": "3004142400-2024-00512", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250129", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20230907", "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": "20250129", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "633026", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20250129", "brand_name": "EXCELSIUS GPS", "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-0343", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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": "", "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": "20250129", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Spinal Column Injury", "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20250128", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "21263246", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250127", "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": "362389060", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS IS BEING REPORTED FOR A PROBLEM FOUND EARLIER. INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. BASED ON THE SHIFT OF THE LEAD OCCURRING AFTER THE THIRD CANNULA PLACEMENT AND BEFORE THE FINAL EVALUATION SCANS, THERE ARE A LIMITED AMOUNT OF POTENTIAL CAUSES FOR THIS SIGNIFICANT SHIFT. THE POTENTIAL CAUSES INCLUDE THE EGPS ARM BEING COMMANDED TO MOVE, THE PATIENTS HEAD MOVING OR SLIPPING FROM THE FIXATION PINS, OR MOVEMENT OF THE PATIENT STABILIZATION STAND (PSS) BETWEEN THE SCAN SHOWING ACCEPTABLE CANNULA PLACEMENT AND THE FINAL EVALUATION SCANS. INVESTIGATION OF THE CASE LOGS SHOWED NO EVIDENCE OF INTENDED EGPS ARM MOTION. THE SYSTEM'S LOGS SHOW NO MOTION OCCURRING BETWEEN THE ACCEPTABLE PLACEMENT OF THE CANNULA AND THE FINAL EVALUATION SCANS. SPECIFICALLY, THE LOGS INDICATE MOTION ENDED APPROXIMATELY 14 MINUTES BEFORE THE SCAN SHOWING ACCEPTABLE CANNULA PLACEMENT WAS IMPORTED, AND MOTION DID NOT BEGIN AGAIN UNTIL APPROXIMATELY 18 MINUTES AFTER THE SCAN SHOWING THE SHIFT WAS IMPORTED. ADDITIONALLY, INVESTIGATION OF THE SCANS REVEALED NO EVIDENCE OF PATIENT HEAD MOVEMENT OR SLIPPAGE FROM THE FIXATION PINS. TRAJECTORIES ALONG EACH FIXATION PIN WERE CREATED TO COMPARE THE POSITIONS BEFORE AND AFTER THE SHIFT OCCURRED IN THIS CASE. HOWEVER, INVESTIGATION OF THE GPS AND E3D LOGS/SCANS COULD NOT DETERMINE OR VERIFY MOVEMENT OF THE PSS DURING THIS CASE. ENGINEERING EVALUATION DID NOT FIND A SYSTEM MALFUNCTION. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT. 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 CAUSE OF THE REPORTED ISSUE CAN BE TRACED TO USER TECHNIQUE." }, { "mdr_text_key": "362389061", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE ARM AND VERIFICATION PROBE WERE AGAIN USED TO CONFIRM THE ENTRY POINTS. A STRYKER PERFORATOR WAS USED TO CREATE A SINGLE BURR HOLE ON THE PATIENTS RIGHT. A STIM-LOCK WAS OPENED AND USED TO TEMPLATE AN AREA THAT THE SURGEON BURRED DOWN WITH A ACORN BIT TO RECESS THE STIM-LOCK. THE ARM WAS SENT AGAIN TO CONFIRM ACCURACY AT THE CENTER OF THE BURR HOLE. THE IGEE TOP TO TARGET WAS SET TO 183MM AND A 216.5MM ALPHA OMEGA CANNULA WAS PLACED TO APPROXIMATELY 10MM ABOVE TARGET. E3D WAS MOVED BACK INTO PLACE AND A SPIN WAS PERFORMED SHOWING A DEVIATION MEDIALLY APPROXIMATELY 1.25MM. THE SURGEON CHECKED ON THE BRAINLAB SERVER AND SAID THAT THEY SHOWED APPROXIMATELY 2.5MM OF DEVIATION. THE AO HEAD STAGE WAS REMOVED AND THE ARM RESETTLED, THIS TIME TO 168MM IGEE TOP TO TARGET. A 201.5MM AO CANNULA WAS PLACED AND E3D WAS MOVED BACK INTO TO POSITION AND ANOTHER SCAN WAS PERFORMED. IT WAS LOADED ONTO THE ROBOT AND AN EVALUATION SHOWED ALMOST IDENTICAL DEVIATION, SUGGESTING THE CANNULA FELL INTO THE PREVIOUS TRACK. THE SURGEON BELIEVED THE TRAJECTORY SET BY THE ROBOT WAS CORRECT, BUT THE CANNULA DEVIATED DUE TO POSSIBLE ANATOMY. HE ADJUSTED THE ALPHA OMEGA XY BASE TO CORRECT FOR THE DEVIATION AND PLACED THE CANNULA AGAIN. E3D WAS MOVED BACK INTO TO POSITION AND ANOTHER SCAN WAS PERFORMED. IT WAS LOADED ONTO THE ROBOT AND AN EVALUATION SHOWED A POSSIBLE OVER CORRECTION; HOWEVER, IT WAS ACCEPTABLE PLACEMENT. A FINAL SCAN ON THE RIGHT SIDE WAS ABOUT TO BE PERFORMED, BUT THE SURGEON WANTED TO ADVANCE THE LEAD PRIOR TO THE SPIN. E3D WAS MOVED BACK INTO TO POSITION AND ANOTHER SCAN WAS PERFORMED. IT WAS LOADED ONTO THE ROBOT AND AN EVALUATION A MASSIVE DEVIATION LATERALLY AT THE DISTAL END AND MEDIALLY AT THE PROXIMAL END. DIRECT VISUALIZATION SHOWED THAT THE CANNULA HAD BENT, SUGGESTING THE BED HAD POSSIBLE MOVED DUE TO A POSSIBLE COLLISION. THE ROBOT AND E3D WAS REMOVED, AND THE PATIENT WAS SENT TO CT FOR FURTHER EVALUATION." } ], "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": "" } ] }