{ "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": "3004142400-2024-00375", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250123", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20221025", "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": "20250123", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1586895", "implant_date_year": "2022", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20250123", "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-0240", "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", "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": "20250805", "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": "20250123", "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": "20250123", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "21218380", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240114", "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": "361982670", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS IS BEING REPORTED FOR A PROBLEM FOUND EARLIER. INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. AN INVESTIGATION OF THE CASE LOGS REVEALED MULTIPLE INSTANCES OF POSSIBLE DRB SHIFTS BEFORE AND DURING NAVIGATION AS WELL AS HIGH DEFLECTION DURING RIGHT SCREW PLACEMENT. THE SOFTWARE ALERTED THE USER WITH A WARNING STATING  \"POSSIBLE SHIFT OF THE DRB DETECTED BY SURVEILLANCE MARKER. TRAJECTORY MOTION DISABLED. PERFORM AN ANATOMICAL LANDMARK CHECK AND RESET SURVEILLANCE IF APPLICABLE\". A DRB SHIFT CAN LEAD TO NAVIGATIONAL INTEGRITY ISSUES AND THE MISPLACEMENT OF SCREWS. AFTER THE \"POSSIBLE SHIFT OF THE DRB\" WARNING IS PRESENTED, WE RECOMMEND PERFORMING AN ANATOMICAL LANDMARK CHECK. WHILE PLACING THE RIGHT SCREW, THE SOFTWARE ALSO DETECTED AND ALERTED THE USER OF EXCESSIVE DEFLECTION DURING SCREW PLACEMENT. THIS CAN BE CAUSED BY SKIVING. THE SCREW WAS CORRECTED INTRAOPERATIVELY AND NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED. 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." }, { "mdr_text_key": "361982671", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING LAST SCREW PLACEMENT (L5R) THE HIGH SPEED DRILL, PILOT DRILL AND THE TAP WERE NAVIGATED ACCURATELY, BUT SCREW WAS NOT. THE SCREW WAS PUT SLIGHTLY IN FORAMEN, IT WAS FOUND IN THE X-RAY VERIFICATION SHOT. SCREW WAS IMMEDIATELY REMOVED AND RE-PLANNED AND AGAIN - HIGH SPEED DRILL, PILOT DRILL AND TAP WERE NAVIGATED ACCURATELY, BUT DURING SCREW PLACEMENT THE DOCTOR SAW AND FELT THAT THE SCREW JUMPED INTO OLD CANAL. ONCE MORE SCREW WAS IMMEDIATELY REMOVED AND RE-PLANNED AND AGAIN HIGH SPEED DRILL, PILOT DRILL AND TAP WERE NAVIGATED ACCURATELY, BUT SCREW WAS PUT WITHOUT ROBOT/NAVIGATION WITH STANDARD SCREWDRIVER AND UNDER X-RAY CONTROL. AFTER DISCUSSION WITH THE REP HE COULDN'T CONFIRM THAT THE OFFSET TURNED TO RED WHEN SCREWDRIVER WAS IN EE." } ], "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": "" } ] }