{ "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": "3004142400-2025-00156", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250731", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20240701", "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": "20250731", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "992215", "implant_date_year": "2025", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20250731", "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-0201", "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": "20250807", "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": "20250731", "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": "20250723", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "22676945", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250701", "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": "376448608", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. THE CASE LOGS PROVIDED REVEALED THERE WAS LIKELY A REGISTRATION SHIFT THAT TOOK PLACE DURING THE PATIENT REGISTRATION. IN THE EVENT A REGISTRATION SHIFT OCCURS, EXCELSIUSGPS PRODUCES A WARNING STATING \"PATIENT REFERENCE UNRELIABLE: THE POSITION OF YOUR PATIENT REFERENCE MAY HAVE MOVED SINCE THE SNAPSHOT WAS TAKEN. THIS MAY RESULT IN INACCURACIES. CONFIRM A SUCCESSFUL LANDMARK CHECK BEFORE TRANSFERRING REGISTRATION.\" ADDITIONALLY, IT WAS REPORTED THAT SCREWS WERE ALL MISPLACED IN THE SAME DIRECTION. THIS CAN BE SYMPTOMATIC OF A REGISTRATION SHIFT DURING THE INTRA-OPERATIVE WORKFLOW. A REGISTRATION SHIFT CAN BE DUE TO AN INTRA-OPERATIVE CT REGISTRATION FIXTURE (ICT) OR DYNAMIC REFERENCE BASE (DRB) SHIFT BETWEEN WHEN THE SURGICAL SNAPSHOT IS CAPTURED AND WHEN THE REGISTRATION IS TRANSFERRED AFTER UPLOADING THE INTRA-OPERATIVE SPIN. IN THIS CASE, THE ICT WAS SHOWN TO BE PARTIALLY RESTING ON THE PATIENT. IF THE ICT IS IN CONTACT WITH THE PATIENT'S SKIN, BREATHING CAN LEAD TO AN ICT SHIFT DURING THE INTRA-OPERATIVE SCAN. A SHIFT OF THE ICT CAN LEAD TO NAVIGATION INTEGRITY ISSUES AND CAN LEAD TO THE MISPLACEMENT OF SCREWS. MOVEMENT OF THE DRB DURING NAVIGATION CAN LEAD TO A LOSS OF NAVIGATIONAL INTEGRITY AND MISPLACED 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. THE CAUSE OF THE REPORTED ISSUE CAN BE TRACED TO USER TECHNIQUE." }, { "mdr_text_key": "376448609", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A SCREW WAS MISPLACED USING THE EXCELSIUS GPS SYSTEM." } ], "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": "" } ] }