{ "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": "3004142400-2026-00023", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260205", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20260120", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "19403", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "6109301800", "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": "20260205", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "327779", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20260205", "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-0278", "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" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260327", "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": "20260205", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "64 YR", "patient_sex": "Female", "patient_weight": "59 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20260205", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "24268158", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260121", "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": "392187276", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. IT WAS REPORTED THAT THERE WAS DIFFICULTY OBTAINING THE PRE-OPERATIVE CT MERGE, RESULTING IN SHIFTS THAT CREATED A LOSS OF NAVIGATIONAL INTEGRITY WHEN PLACING IMPLANTS AT L1. THE LATERAL SHOTS APPEAR TO HAVE ARTIFACT WITHIN THE IMAGE THAT WILL MAKE IT DIFFICULT FOR THE SOFTWARE TO PROPERLY IDENTIFY ANATOMY OF INTEREST WITHIN THE FLAT PANEL FLUORO FIXTURE (FPFF) IMAGES AS WELL AS PERFORM THE PRE-OPERATIVE REGISTRATION. ULTIMATELY, THE USER OPTED TO REPLACE THE IMPLANTS AT L1 USING TRADITIONAL METHODS AND THE CASE WAS COMPLETED WITH NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THIS EVALUATION HAS BEEN COMPLETED WITH ASSOCIATED CASE LOGS AND THERE ARE NO ASSOCIATED WORK ORDER OR PART RETURNS. 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": "392187277", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT IN AN EXCELSIUS GPS SURGERY, IT WAS NOTICED THAT AFTER TAKING X-RAYS IN THE OR FOR THE PRE OP CT WORKFLOW AND DOING THE MERGE, THE PLANNED SCREWS WERE TOTALLY WRONG IN THE X-RAY. WE TOOK THEM OUT TO BE NOT HASSITATED. WHEN WE PLACED THE FIDUCIALS INTO THE LATERAL VIEW VERTEBRA, THE AP ONES WERE COMPLETELY OFF AND NEEDED TO BE PLACED IN THE CENTRE. THEN WE HAD AN ANATOMICAL SHIFT IN LATERAL VIEW. WE COULD NOT CHOOSE ALL THE DIFFERENT VIEWS LIKE STANDARD OR STANDARD OPTIMIZED OR L2 SEED AUTOMATICALLY." } ], "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": "" } ] }