{ "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": "2026-10-07", "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": "+1(610)9", "event_type": "Injury", "report_number": "3004142400-2026-00164", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260730", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20260715", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "19403", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "+1(610)930-1800", "noe_summarized": "1", "manufacturer_contact_l_name": "Paul", "source_type": [ "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "19403", "manufacturer_g1_state": "PA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "", "date_added": "20260731", "manufacturer_contact_f_name": "Daniel", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "142130", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260730", "brand_name": "EXCELSIUS GPS", "generic_name": "Robot, Surgical, navigation unit", "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-0603", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20260928", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260730", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "180 LB", "patient_ethnicity": "", "patient_race": "White", "patient_problems": [ "Pain", "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20260730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "Audubon", "mdr_report_key": "50086781", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260715", "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": "15858695206", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "It was reported that the initial surgery for an l1 fracture with fusion from t11 to l3 was performed in (b)(6) 2026. The inraoperative control x-rays were obtained and did not show any evidence of abnormal screw placement. Some time later, the patient underwent a second procedure consisting of an l1 corpectomy. The patient has now returned with pain, and a recent ct scan demonstrates that the screws at t11, t12, and l2 are laterally misplaced to the right side." }, { "mdr_text_key": "16358695207", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "Investigation revealed that there was no system malfunction. A warning was generated during navigation for the T11 right, L2 left, and L2 right screw trajectories. Navigation was continued despite the warnings, which contributed to inaccurate navigation and subsequent incorrect screw placement. The severity observed did not exceed the anticipated severity. 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 can be 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": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }