{ "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": "3004142400-2024-00184", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240827", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20240730", "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": "20240827", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "127742", "implant_date_year": "2024", "date_removed_year": "2024", "serviced_by_3rd_party_flag": "U", "date_received": "20240827", "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-0474", "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": "20250820", "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": "20240827", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "61 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "White", "patient_problems": [ "Spinal Column Injury", "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20240827", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "20079205", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240730", "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": "350300612", "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. THE REST OF THE SURGERY WAS PERFORMED FREEHAND." }, { "mdr_text_key": "350300961", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. OUR PRELIMINARY INVESTIGATION, THROUGH REVIEW OF THE CASE LOGS, REVEALED THAT THERE WAS A PRE-OPERATIVE MERGE SHIFT THAT LED TO THE MISPLACEMENT OF SCREWS. IT WAS SHOWN THROUGH THE CASE LOGS THAT COLLIMATION OF DIGITAL RADIOGRAPHY (DR) SHOTS WAS ATTEMPTED BUT THOSE SHOTS WERE NOT USED FOR THE MERGE. THE EXCLESIUS3D USER MANUAL RECOMMENDS USING COLLIMATION TO ALLOW FOR THE X-RAY BEAM TO BE SHAPED TO LIMIT EXPOSURE TO THE AREA OF INTEREST ON THE PATIENT TO PROVIDE HIGHER CONTRAST IMAGING. IT IS ALSO RECOMMENDED THAT THE USER SHOULD VERIFY REGISTRATION FOR EACH LEVEL PRIOR TO NAVIGATION. THE EXCELSIUSGPS SPINE MODULE USER MANUAL ALSO RECOMMENDS TO ALTERNATE BETWEEN THE CT SCAN IMAGES WITH THE PLANNED SCREWS AND THE 2D IMAGES WITH THE LEVEL INDICATOR AT EACH LEVEL TO CONFIRM PROPER REGISTRATION. AFTER REGISTRATION HAS BEEN COMPLETED, PERFORM A LANDMARK CHECK OR VERIFICATION TO ENSURE THAT THE REGISTRATION WAS SUCCESSFULLY CALCULATED. A FIELD SERVICE ENGINEER IS DISPATCHED TO VERIFY IMAGE QUALITY CALIBRATIONS OF EXCELSIUS3D TO ENSURE THERE ARE NO ISSUES WITH THE SYSTEM. THE OBSERVED OVERALL RISK LEVEL IS 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 WAS 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": "610", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }