{ "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": "3004142400-2024-00048", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240312", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20240212", "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": "20240312", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "721176", "implant_date_year": "2024", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20240312", "brand_name": "EXCELSIUS", "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-0208", "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": "", "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": "20240312", "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": "20240312", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "18888339", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240212", "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": "337472370", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. THE PURPOSE OF THIS INVESTIGATION IS TO EVALUATE THE RISK ASSOCIATED WITH THE IDENTIFIED FAILURE MODE OF \"MISPLACED TOOLS OR IMPLANTS\" FOR EXCELSIUSGPS. INVESTIGATION OF THE CASE LOGS SHOWED THAT THE ROOT CAUSE OF THE MISPLACED IMPLANTS IS DUE TO A COMBINATION OF SKIVING, PATIENT MOVEMENT RELATIVE TO THE DRB AND TRACKING ERRORS IN THE FLUOROSCOPIC IMAGES. FOR SKIVING, THE USER REPORTED THAT THEY SKIVED DUE TO SMALL AND SCLEROTIC PEDICLES. ADDITIONALLY, INVESTIGATION OF THE CASE LOGS SHOWED THAT THE SOFTWARE DETECTED EXCESSIVE FORCES ON THE LOAD CELL DURING BONE WORK. THIS IS THE RESULT OF SKIVING FORCES DETECTED WHILE A TOOL IS INSERTED INTO THE END EFFECTOR. THE SOFTWARE CORRECTLY DETECTED THIS FORCE AND ALERTED THE USER. MISPLACED SCREWS DUE TO SKIVING IS BEING FURTHER INVESTIGATED IN RELATIONSHIP TO CAPA-23-0052. FOR PATIENT MOVEMENT RELATIVE TO DRB, IT WAS REPORTED THAT THE SURGEON CONTINUED TO DISSECT AND INCISE FURTHER FOLLOWING PATIENT REGISTRATION. THIS CAN LEAD TO MOVEMENT OF THE PATIENT'S ANATOMY RELATIVE TO THE DRB, RESULTING IN MISPLACED IMPLANTS. FURTHERMORE, REVIEW OF THE FLUOROSCOPIC IMAGES REVEALED THAT ASSIGNED IMAGES CONTAINED TRACKING ERRORS. A TRACKING ERROR CAN OCCUR IF THE C-ARM MOVES WITH RESPECT TO THE PATIENT BETWEEN X-RAY EMISSION AND WHEN THE IMAGE IS RECEIVED BY THE EXCELSIUSGPS SOFTWARE. TRACKING ERRORS CAN LEAD TO PREOPERATIVE MERGE SHIFTS AND NAVIGATIONAL INTEGRITY ISSUES. THE CAUSE OF THE REPORTED ISSUE WAS TRACED TO USER TECHNIQUE." }, { "mdr_text_key": "337472371", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A SCREW USING THE EXCELSIUS GPS SYSTEM WAS MISPLACED INTRA-OPERATIVELY CAUSING A CSF (CEREBRAL SPINAL FLUID) LEAK." } ], "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": "" } ] }