{ "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": "3004142400-2026-00038", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260213", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20240806", "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": "UK", "manufacturer_contact_area_code": "", "date_added": "20260213", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "392655", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20260213", "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-0479", "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" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260327", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260213", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20260213", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "24335305", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20251219", "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": "393120354", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, SCREW WAS MISPLACED DURING A PROCEDURE WITH EGPS. THE SURGEON FOUND OUT VIA INTRA-OPERATIVE CT WHEN SWITCHING SYSTEMS TO STEALTH NAVIGATION. HAVING STRUGGLED TO OBTAIN GREEN BOARDER TRAJECTORIES FOR THE FIRST TWO SCREWS USING EGPS, A LANDMARK CHECK WAS CARRIED OUT AND IT WAS DISCOVERED THAT THE REGISTRATION WAS NOT ACCURATE. IT WAS AT THIS POINT THAT THE SURGEON REQUESTED TO CEASE USING EGPS AND TO OBTAIN ANOTHER O-ARM SPIN AND PROCEED WITH STEALTH NAVIGATION. CASE WAS AN MIS TUMOR STABILIZATION FOR L3 TUMOR. THE PLAN WAS TO INSTRUMENT L1,L2, L4 AND L5." }, { "mdr_text_key": "393120355", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION.IT WAS REPORTED BY A GLOBUS MEDICAL REPRESENTATIVE THAT AN IMPLANT WAS MISPLACED AT L2-L. AN INVESTIGATION INTO THE CASE LOGS PROVIDED REVEALED THAT THE ROOT CAUSE WAS A DYNAMIC REFERENCE BASE (DRB) SHIFT THAT OCCURRED DURING NAVIGATION. FURTHER DISCUSSIONS WITH THE GLOBUS MEDICAL REPRESENTATIVE REVEALED THAT THE DYNAMIC REFERENCE BASE (DRB) HAD LOST PURCHASE IN THE BONE DURING THE PROCEDURE. THIS CAN LEAD TO A REGISTRATION SHIFT OR DYNAMIC REFERENCE BASE (DRB) SHIFT. BOTH REGISTRATION AND DRB SHIFTS CAN RESULT IN A LOSS OF NAVIGATIONAL INTEGRITY. AFTER THE REGISTRATION HAS BEEN COMPLETED, IT IS RECOMMENDED TO PERFORM A LANDMARK CHECK OR VERIFICATION TO ENSURE THAT THE REGISTRATION WAS SUCCESSFULLY CALCULATED. USING THE NAVIGATED VERIFICATION PROBE, TOUCH AN ANATOMICAL LANDMARK AND VERIFY THAT THE CORRESPONDING LOCATION IS SHOWN ON THE SYSTEM MONITOR . ULTIMATELY, THE USER OPTED TO ABORT EXCELSIUSGPS USAGE TO USE A COMPETITIVE SYSTEM TO REPLACE THE IMPLANT WITH NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THE SEVERITY OBSERVED DID NOT EXCEED THE ANTICIPATED SEVERITY. 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." } ], "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": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }