{ "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": "3004142400-2024-00388", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250123", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20221212", "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": "1586901", "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-0319", "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": "21218428", "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": "361961133", "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 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. THE SOFTWARE ALSO DETECTED AND ALERTED THE USER OF EXCESSIVE DEFLECTION DURING SCREW PLACEMENT. THIS CAN BE CAUSED BY SKIVING. THE MISPLACED IMPLANTS WERE CORRECTED INTRAOPERATIVELY AND THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT. 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": "361961134", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text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} ], "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": "" } ] }