{ "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": "N", "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": "+1(610)9", "event_type": "Injury", "report_number": "3004142400-2026-00106", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260526", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20260427", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "19403", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "+1(610)930-1800", "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": "20260526", "manufacturer_contact_f_name": "Daniel", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "183879", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260526", "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-0604", "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": "AL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/31/2026", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260922", "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": "20260526", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "White", "patient_problems": [ "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20260806", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "Audubon", "mdr_report_key": "25284386", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260428", "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": "402412310", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE WAS UNAVAILABLE FOR EVALUATION. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE." }, { "mdr_text_key": "402412311", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT IN AN EXCELSIUS GPS SURGERY, AFTER REGISTRATION, ROBOT WAS BROUGHT INTO THE FIELD. THE SURGEON SELECTED LL2 AND ARM MOVED TO TRAJECTORY BUT INSTEAD OF MOVING TOWARDS THE PATIENT THE ARM, WHILE ON TRAJECTORY, MOVED BACK AWAY FROM THE PATIENT. THIS KEPT HAPPENING UNTIL A NEW SCREW TRAJECTORY WAS SELECTED, THEN ARM MOVED TOWARDS PATIENT. EXCEPT, THE ARM WAS COMING AS CLOSE AS IT COULD TO THE SKIN AND STOPPING DUE TO FORCE AGAINST THE EE. AFTER MARKING, ARM WAS MOVED OUT OF THE FIELD FOR EXPOSURE. THE ARM WAS MOVED BACK INTO THE FIELD AND MOVE TO TRAJECTORY BUT INSTEAD OF TOUCHING SKIN IT STOPPED A MORE EXPECTED HEIGHT ABOVE THE PATIENT'S SKIN. WE THOUGHT THAT NAV WAS OFF BECAUSE AT THE SAME TIME, SM WENT TO RED AND DRB/SM SHIFT ALERT OCCURRED. THE SURGEON DID A NAVIGATIONAL CHECK WITH VERIFICATION PROBE AND IT WAS DETERMINED THE NAV WAS OKAY DESPITE THE NEW HEIGHT ON THE ARM. THE SM WAS RESET USING UI BUTTON. THE RIGHT/DOWNSIDE L2-L5 PLACED WITHOUT ISSUES. THE LEFT L2 THEN ATTEMPTED TO BE PLACED BUT KEPT SKIVING LATERALLY BUT PLAN SEEMED GOOD. THE SCREW WAS SKIPPED. THE LL3-4 PLACED WITHOUT ISSUE. THE LL5 SKIPPED. NO ISSUES DURING INTERBODY PORTION OF NAVIGATION OTHER THEN OCCASIONAL SM FLICKERING, LIKELY DUE TO PAIRING WITH UI." } ], "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": "08/06/2026" } ] }