{ "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": "3004142400-2025-00249", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251030", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20250930", "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": "AS", "manufacturer_contact_area_code": "610", "date_added": "20251030", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2745765", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20251030", "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-0427", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251120", "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": "20251030", "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": "20251030", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "23424488", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20251001", "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": "383925226", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. WHILE UTILIZING EXCELSIUSGPS IT WAS REPORTED TO GLOBUS MEDICAL THAT IMPLANTS AT L4-R AND L5-R WERE MISPLACED SUPERIOR AND LATERAL TO THE INTENDED TRAJECTORY. AN INVESTIGATION OF THE CASE LOGS REVEALED THAT THE ROOT CAUSE WAS A COMBINATION OF DYNAMIC REFERENCE BASE (DRB) SHIFTS AND EXCESSIVE DEFLECTION FORCES DURING NAVIGATION. MOVEMENT OF THE DRB DURING NAVIGATION CAN LEAD TO A LOSS OF NAVIGATIONAL INTEGRITY AND MISPLACED IMPLANTS. BOTH L4-R AND L5-R WERE MISPLACED IN THE SAME DIRECTION, WHICH CAN BE INDICATIVE OF A DRB SHIFT. THE CASE LOGS ALSO SHOWED THAT THE SOFTWARE DETECTED AND THEN ALERTED THE USER OF EXCESSIVE DEFLECTION FORCES ON THE END EFFECTOR, WHICH CAN INDICATE SKIVING. SKIVING CAN LEAD TO THE MISPLACEMENT OF IMPLANTS. ULTIMATELY, L5-R WAS REMOVED AND REPLACED WITH THE USAGE OF TRADITIONAL METHODS. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED. THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH DOES NOT EXCEED 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 WAS TRACED TO USER TECHNIQUE." }, { "mdr_text_key": "383925227", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A SINGLE POSITION LATERAL USING EGPS AND AIRO. L3-S1 FIXATION WITH L3-4 L4-5 LATERAL FUSION. THERE WERE HIGH SKIVE WARNINGS ON R L4 SCREW INSERTION. THE SCREW PLACED SLIGHTLY SUPERIOR AND LATERAL TO PLAN. THE SURGEON ATTEMPTED TO PLACE SCREW MULTIPLE TIMES AND EACH ATTEMPT GAVE HIGH SKIVE WARNINGS DESPITE HS DRILL AND SIDE CUTTING DRILL FOLLOWING TRAJECTORY. IT WAS NOT TAPPED. THERE WERE NO SURVEILLANCE WARNINGS. IT WAS THEIR FIRST CASE WITH EGPS 6.1 SOFTWARE USING RELINE SCREWS. THE R L5 SCREW HAD SIMILAR ISSUE AND WAS FINALLY PLACED OVER K-WIRE. (AWL - K-WIRE - NON-NAVIGATED DRIVER) ON AIRO SCAN REVIEW THE R L4 SCREW WAS PLACED SLIGHTLY SUPERIOR AND LATERAL TO PLAN. SCREW WAS REMOVED AND NOT REPLACED. THE PATIENT SHOWED NO ADVERSE EFFECTS FROM MISPLACED SCREW." } ], "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": "" } ] }