{ "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": "2026-10-07", "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": "3004142400-2026-00107", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260528", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20260429", "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": "", "date_added": "20260528", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "367917", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20260528", "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-0615", "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": "", "udi_public": "", "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": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260810", "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": "20260528", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "Asian, Black Or African American", "patient_problems": [ "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20260528", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "25319782", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260430", "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": "402689542", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING AN EXCELSIUS GPS CASE, WE WERE RUNNING A PRE-OP MERGE FOR ROBOTIC REGISTRATION, AND THE ROBOT FROZE. IT KICKED ME BACK TO THE INITIAL LOG IN SCREEN. WE HAD TO RE LOG IN TO SURGEON PROFILE AND GO BACK INTO CASE. WE WENT BACK TO REGISTER AND PROCEEDED. THIS IS THE SECOND TIME WE HAVE SEEN THIS. SECONDLY, RIGHT L4 SCREW WAS PLACED SUPERIORLY. DURING CASE, IT APPEARED THAT THE PA PLACING SCREW SKIVVED THE HS BURR AND DRILL SUPERIORLY, IN WHICH WE SPOKE UP ABOUT AND SUGGESTED THAT THEY RE-DO THIS SEQUENCE. AS HE WAS PLACING SCREW, THE SCREW ALSO LOOKED SUPERIOR AND NOT TO PLAN, WE ONCE AGAIN SPOKE UP AND SUGGESTED TO RE PLACE SCREW. ONCE FINALLY PLACED SCREW AND TOOK IMAGE, SCREW WAS SUPERIOR TO PEDICLE. WE REPLANNED A NEW TRAJECTORY. THE DOCTOR TOOK OUT SCREW AND TRIED TO DO FREE-HAND NAV BUT STILL FELT THE SCREW WAS NOT TO PLAN. HE ENDED UP USING JAMSHIDI TECHNIQUE AND NO NAV OR ROBOT TO PLACE." }, { "mdr_text_key": "402689543", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. THE CASE WAS COMPLETED WITH NO ADVERSE EFFECTS TO THE PATIENT REPORTED. UPON REVIEWING THE CASE LOGS, IT WAS UNDERSTOOD THAT THE ACCEPTED MERGE AT L4 WAS NOT ACCURATE. THE MERGE ON THE LAT SHOT WAS FINE, BUT THERE WAS A LONGITUDINAL SHIFT IN THE AP SHOT, WHICH RESULTED IN THE SCREW BEING PLACED SUPERIOR TO THE PLAN. THE USER IS ADVISED TO PERFORM A THOROUGH REVIEW OF THE MERGE BEFORE ACCEPTING IT. 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": "" } ] }