{ "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": "3004142400-2026-00098", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260515", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20260415", "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": "20260515", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2246028", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20260515", "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": "R", "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": "20260515", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "White", "patient_problems": [ "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20260515", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "25191052", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260416", "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": "401490889", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A SURGERY USING THE EXCELSIUS GPS, THE LEFT T5 SCREW INITIALLY WAS PLACED MEDIALLY BREACHING CANAL A FEW MILLIMETERS (VIA CT SCAN WITH E3D). ONCE IDENTIFIED, WE SUGGESTED TO DOCTOR TO REPLAN AND RE PLACE SCREW ON A NEW CT SCAN REGISTRATION, AND RE PLACE SCREW LATERALLY. WE SUGGESTED USING A LARGER SCREW, BUT HE WANTED TO STAY AT A 4.5 SCREW. THE NEW SCREW PLACED MORE LATERALLY IN PEDICLE AND NOT BREACHING CANAL FROM WHAT WE COULD TELL ON FINAL X-RAYS. WE ARE REPORTING BECAUSE WE FELT AS THOUGH WE WERE KEEPING A KEEN EYE ON THE EGPS SCREEN FOLLOWING PROTOCOLS FOR NAVIGATION, AND WE DID NOT FEEL ALERTED/ALARMED WHEN PLACING SCREW, FOR THE SCREW TO LOOK MEDIAL AS IT APPEARED ON CT SCAN. WE DID HOWEVER NOTICE WHEN HE FIRST USED THE HS DRILL ON T5L, IT DID LOOK MEDIAL TO US. WE RE-SETTLED THE ROBOTIC ARM ON TO TRAJECTORY AND PROCEEDED. THE REPLACED SCREW WAS TO PLAN, NO SCREW LEFT BREACHING CANAL." }, { "mdr_text_key": "401490890", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. A REVIEW OF THE CASE LOGS AND CONVERSATIONS REVEALED THAT THE NAVIGATIONAL INACCURACIES EXPERIENCED IN THIS CASE WERE DUE TO DYNAMIC REFERENCE BASE (DRB) SHIFTS. DRB SHIFTS CAN CAUSE NAVIGATIONAL INTEGRITY ISSUES AND CAN LEAD TO THE MISPLACEMENT OF IMPLANTS. UNSTABLE FRACTURE AT T9 LIKELY CAUSED A SHIFT IN REGISTRATION, THEREBY IMPACTING NAVIGATION. THE USER ACKNOWLEDGES THAT THEY PERFORMED ANATOMICAL LANDMARK CHECKS WITH EACH NEW INSTRUMENT OR LEVEL TO ENSURE NAVIGATIONAL INTEGRITY BEFORE PROCEEDING WITH NAVIGATION AS RECOMMENDED. NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THIS EVALUATION HAS BEEN COMPLETED VIA ASSOCIATED CASE LOGS AND THERE ARE NO ASSOCIATED WORK ORDER OR PART RETURNS. THE SEVERITY OBSERVED DID NOT EXCEED THE ANTICIPATED SEVERITY. THE OBSERVED OVERALL RISK LEVEL IS 5, OR 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": "" } ] }