{ "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": "3004142400-2025-00275", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251111", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20251015", "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": "610", "date_added": "20251111", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1477302", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20251111", "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-0512", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "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": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/12/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260212", "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": "20251111", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20251208", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "23525772", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20251020", "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": "384874510", "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": "384874511", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE SURGEON HAS HAD ISSUES WITH ACCURACY WHEN PLACING THE DRILL IN END EFFECTOR. OUR PLANS LOOK REALLY GOOD AND THEN THIS CHANGES WHEN A DRILL IS PLACED IN END EFFECTOR. THE TRAJECTORY IS WAY OFF AND MEDIAL FROM CHOSEN PLAN. WE DID EVERYTHING THAT CSR RECOMMENDED TO TROUBLE SHOOT, BUT THE PROBLEM PERSISTED. AFTER ATTEMPTING TO TROUBLESHOOT IS WHEN WE ABORTED SCREW INSERTION." }, { "mdr_text_key": "392851266", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE SURGEON HAS HAD ISSUES WITH ACCURACY WHEN PLACING THE DRILL IN END EFFECTOR. OUR PLANS LOOK REALLY GOOD AND THEN THIS CHANGES WHEN A DRILL IS PLACED IN END EFFECTOR. THE TRAJECTORY IS WAY OFF AND MEDIAL FROM CHOSEN PLAN. WE DID EVERYTHING THAT CSR RECOMMENDED TO TROUBLE SHOOT, BUT THE PROBLEM PERSISTED. AFTER ATTEMPTING TO TROUBLESHOOT IS WHEN WE ABORTED SCREW INSERTION." }, { "mdr_text_key": "392851267", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED FOR AN INCIDENT THAT OCCURRED EARLIER. THE PURPOSE OF THIS INVESTIGATION IS TO EVALUATE THE RISK ASSOCIATED WITH THE IDENTIFIED FAILURE MODE OF NAVIGATIONAL INTEGRITY FOR EXCELSIUSGPS. THE USER REPORTED A LOSS OF NAVIGATIONAL INTEGRITY WHEN ATTEMPTING TO NAVIGATE. AN INVESTIGATION INTO THE CASE LOGS REVEALED THAT A MERGE SHIFT OCCURRED AT LEVELS L4 AND S1, CAUSING AN ANTERIOR SHIFT OF THE ANATOMY. THE PRE-OPERATIVE MERGE CAN BE MORE DIFFICULT TO OBTAIN DEPENDING ON THE QUALITY OF THE PREOPERATIVE CT SCAN, QUALITY OF THE FLUOROSCOPIC IMAGES AND PATIENT ANATOMY. DURING THE INVESTIGATION, IT WAS NOTED THAT THE ACQUIRED LAT IMAGES CONTAINED LITTLE DETAIL OF THE ANATOMICAL LANDMARKS OF INTEREST DUE TO THE LOW LEVEL OF CONTRAST IN THE IMAGES AS WELL AS THE PRESENCE OF SHADOWS AND OTHER ARTIFACTS WHICH MAY HAVE MADE IT MORE DIFFICULT FOR THE SYSTEM TO ACCURATELY REGISTER THE PATIENT. PREOPERATIVE MERGE SHIFTS CAN CAUSE NAVIGATIONAL INTEGRITY AND CAN LEAD TO THE MISPLACEMENT OF IMPLANTS. THE USER MUST VERIFY THE PREOPERATIVE MERGE BEFORE PROCEEDING WITH NAVIGATION. THE USER ACKNOWLEDGES THAT THEY WILL PERFORM AN ANATOMICAL LANDMARK CHECK WITH EACH NEW INSTRUMENT OR LEVEL TO ENSURE NAVIGATIONAL INTEGRITY BEFORE PROCEEDING WITH NAVIGATION. ULTIMATELY, THE CASE WAS ABORTED AND NO ADVERSE EFFECTS TO THE PATIENT WERE 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 LOW, WHICH DOES NOT EXCEED THE OBSERVED ANTICIPATED RISK LEVEL; THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED FOR THIS SUPPLEMENTAL REPORT: B4, G3, G6, H2, H3, H6, H10." } ], "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": "12/08/2025" } ] }