{ "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": "3004142400-2024-00244", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20241031", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20241001", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "19403", "reporter_occupation_code": "003", "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": "20241031", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1804702", "implant_date_year": "2024", "date_removed_year": "2024", "serviced_by_3rd_party_flag": "U", "date_received": "20241031", "brand_name": "EXCELSIUS GPS", "generic_name": "SYSTEM, EXCELSIUS GPS, 120V", "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-0361", "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": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250725", "health_professional": "", "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": "20241031", "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": "20241030", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "20579310", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20241001", "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": "355538816", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. OUR INVESTIGATION REVEALED THAT THE MISPLACED IMPLANTS WAS LIKELY THE RESULT OF A COMBINATION OF FACTORS INCLUDING A PARTIAL OCCLUSION OF THE DYNAMIC REFERENCE BASE (DRB) DURING SCAN ACQUISITION WITH EXCELSIUS3D (E3D), A DYNAMIC REFERENCE BASE (DRB) SHIFT, AND EXCESSIVE DEFLECTION FORCES ON THE END EFFECTOR, OR SKIVING, WHILE NAVIGATING INSTRUMENTS THROUGH THE END EFFECTOR. WHEN UTILIZING A CLEAR DRAPE FOR THE DRB DURING THE AUTO-REGISTRATION WORKFLOW WITH E3D, IT IS IMPORTANT TO ENSURE THAT THE CREASES OF THE DRAPE DO NOT ALIGN WITH THE TRACKING MARKERS, TO ENSURE PROPER TRACKING THROUGH THE DRAPE. 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. THE CASE LOGS INDICATED THAT THE SYSTEM CORRECTLY DETECTED AND ALERTED THE USER OF POTENTIAL DRB SHIFTS WHILE NAVIGATING IMPLANTS. DRB SHIFTS CAN CAUSE NAVIGATIONAL INTEGRITY ISSUES AND CAN LEAD TO THE MISPLACEMENT OF IMPLANTS. 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. IF THE ANATOMICAL LANDMARK CHECK IS INACCURATE, THE USER CAN REREGISTER VIA THE \"LIFE-SAVER\" OR \"BAIL OUT\" BUTTON. THE CASE LOGS FROM THE PROCEDURE ALSO SHOWED NUMEROUS WARNINGS STATING THAT EXCESSIVE DEFLECTION FORCE WAS DETECTED WHILE NAVIGATING INSTRUMENTS ON TRAJECTORY. EXCESSIVE DEFLECTION FORCE ON THE END EFFECTOR HAVE THE ABILITY TO CAUSE THE INSTRUMENT TO SKIVE DEPENDING ON THE TECHNIQUE OF THE USER. INSTRUMENT SKIVING CAN ALSO LEAD TO THE MISPLACEMENT OF IMPLANTS. THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH MATCHES THE OBSERVED ANTICIPATED RISK LEVEL; THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED." }, { "mdr_text_key": "355538817", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED." } ], "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": "" } ] }