{ "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": "3004142400-2020-00018", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240119", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20200113", "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": "20240119", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2478866", "implant_date_year": "2020", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20240119", "brand_name": "EXCELSIUS", "generic_name": "SYSTEM, EXCELSIUS GPS, 120V, PRODUCT CODE: OLO", "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-0132", "other_id_number": "", "device_availability": "No answer provided", "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": "20250819", "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": "20240119", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "Hispanic", "patient_race": "", "patient_problems": [ "Spinal Column Injury", "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20240119", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "18546474", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200210", "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": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "333314908", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION CONFIRMED ONE SCREW WAS PLACED LOW TO PLAN WHICH CAUSED LOWER RESPONSE WITH NEUROSTIMULATOR (SSEP) AT THE CORRESPONDING LEVEL. THE SCREW WAS FULLY REMOVED AND REPOSITIONED INTRA-OPERATIVELY TO A NEW TRAJECTORY. IMMEDIATELY POST­ OPERATIVE ·THE PATIENT HAD LIMITED MOVEMENT TO  THE LOWER LEG AND FOOT, SUGGESTIVE OF NEUROLOGIC DEFICIT. EVALUATION OF THE SYSTEM CASE LOGS REVEALED THE USER HAD CAPTURED IMAGING AFTER THE C-ARM HAD SHIFTED FROM THE POSITION IN WHICH THE X-RAY WAS TAKEN. THE SYSTEM CAN DETECT SHIFTS IN THE POSITION OF THE PATIENT REFERENCE ARRAY DURING IMAGING AND NAVIGATION ONLY AFTER THE SURVEILLANCE MARKER IS REGISTERED. IN THIS CASE, THE SURVEILLANCE MARKER WAS REGISTERED AFTER NAVIGATION HAD ALREADY BEGUN. THE USER MANUAL INSTRUCTS THE USER LO PERFORM LANDMARK CHECKS IN CASE OF POSSIBLE SHIFTS IN THE PATIENT REFERENCE ARRAY AND TO RE­ IMAGE THE PATIENT IF NECESSARY. THE SCREW WAS PLACED LOW TO PLAN DUE TO TRACKING ERRORS AS A RESULT OF THE FLUOROSCOPIC IMAGES SELECTED, AND DUE TO INEFFECTIVE USE OF LANDMARK CHECKS." }, { "mdr_text_key": "333314909", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THE LEFT LS SCREW WAS PLACED LOW TO PLAN. THE SCREW WAS REPOSITIONED INTRA-OPERATIVELY TO A NEW TRAJECTORY USING FLUOROSCOPIC IMAGING. IMMEDIATELY POST-OPERATIVE THE PATIENT HAD LIMITED MOVEMENT TO THE LOWER LEG AND FOOT. 28 DAYS LATER, THE SURGEON REPORTED THAT THE PATIENT HAD STARTED TO RECOVER MOVEMENT AND BELIEVED THIS IMPROVEMENT WOULD CONTINUE." } ], "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": "" } ] }