{ "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": "3004142400-2024-00299", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20241218", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20241031", "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": "20241218", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1988807", "implant_date_year": "2024", "date_removed_year": "2024", "serviced_by_3rd_party_flag": "U", "date_received": "20241218", "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-0450", "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", "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": "20250825", "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": "20241218", "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": "20241217", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "20964708", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20241120", "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": "359567175", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE EVALUATION OF THE CASE LOGS INDICATED THAT THE MISPLACEMENT OF THE IMPLANTS WAS LIKELY DUE TO A COMBINATION OF THE PATIENT REGISTRATION CONTAINING A PRE-OPERATIVE MERGE SHIFT AND EXCESSIVE DEFLECTION FORCES ON THE END EFFECTOR, OR SKIVING, WHILE NAVIGATING INSTRUMENTS THROUGH THE END EFFECTOR. THE PREOPERATIVE MERGE CAN BE MORE DIFFICULT DEPENDING ON THE QUALITY OF THE PREOPERATIVE CT SCAN, QUALITY OF THE FLUOROSCOPIC IMAGES AND PATIENT ANATOMY. PREOPERATIVE MERGE SHIFTS CAN CAUSE NAVIGATIONAL INTEGRITY AND CAN LEAD TO THE MISPLACEMENT OF IMPLANTS. ADDITIONALLY, THE CASE LOGS FROM THE PROCEDURE SHOWED SEVERAL 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 LEAD TO THE MISPLACEMENT OF IMPLANTS. THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH MATCHES THE ANTICIPATED RISK LEVEL; THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED." }, { "mdr_text_key": "359567176", "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 POST OP CT SCAN SHOWS A MEDIAL BREACH OF THE L4 SCREW." } ], "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": "" } ] }