{ "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": "3004142400-2024-00193", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20240823", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20240801", "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": "20240823", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1698115", "implant_date_year": "2024", "date_removed_year": "2024", "serviced_by_3rd_party_flag": "U", "date_received": "20240823", "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-0500", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "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", "Human-Device Interface Problem" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/01/2024", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250822", "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": "20240823", "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": "20240917", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "20054484", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240801", "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": "350042983", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THERE WAS NO SYSTEM MALFUNCTION. THE CASE LOGS INDICATED THAT THE MISPLACEMENT OF THE IMPLANTS WAS LIKELY DUE TO THE PATIENT REGISTRATION CONTAINING A PRE-OPERATIVE MERGE SHIFT. THE PREOPERATIVE MERGE CAN BE MORE DIFFICULT DEPENDING ON THE QUALITY OF THE PREOPERATIVE CT SCAN, QUALITY OF THE FLUOROSCOPIC IMAGES AND PATIENT ANATOMY. PREOPERATIVE MERGE SHIFTS CAN CAUSE NAVIGATIONAL INTEGRITY AND CAN LEAD TO THE MISPLACEMENT OF IMPLANTS. THE USER MUST VERIFY THE PREOPERATIVE MERGE BEFORE PROCEEDING WITH NAVIGATION. THE USER ACKNOWLEDGES THAT THEY WILL PERFORM AN ANATOMICAL LANDMARK CHECK WITH EACH NEW INSTRUMENT OR LEVEL TO ENSURE NAVIGATIONAL INTEGRITY BEFORE PROCEEDING WITH NAVIGATION. INVESTIGATION OF THE CASE LOGS SHOW THAT THE PATIENT'S ANATOMY, SUCH AS PEDICLES AND ENDPLATES, IS BOTH NOT SUFFICIENTLY CAPTURED WITHIN THE FIDUCIALS AND DIFFICULT TO IDENTIFY IN THE FLUOROSCOPIC IMAGES DUE TO THE LOW LEVEL OF CONTRAST IN THE IMAGES AS WELL AS THE PRESENCE OF SHADOWS AND OTHER ARTIFACTS IN THE IMAGES. THE SEVERITY OBSERVED DID NOT EXCEED THE ANTICIPATED SEVERITY. THIS IS EQUAL TO THE 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 WAS TRACED TO USER TECHNIQUE." }, { "mdr_text_key": "350042984", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM. THIS EVENT OCCURRED IN GERMANY." }, { "mdr_text_key": "352967469", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. IT WAS REPORTED TO GLOBUS MEDICAL THAT THE POSTOPERATIVE FLUOROSCOPY IMAGES REVEALED THAT SCREWS WERE INSERTED ONE LEVEL BELOW THE INTENDED TARGET. SCREWS WERE PLANNED TO BE INSERTED ON LEVELS L4 AND L5 BUT WERE PLACED IN L5 AND S1. A REVISION SURGERY WAS PERFORMED ON THE SAME DAY BY REPLACING THE SCREWS AT THE L4/L5 LEVEL USING TRADITIONAL METHODS. OUR INVESTIGATION, THROUGH REVIEW OF THE CASE LOGS, REVEALED THAT THERE WAS A PRE-OPERATIVE MERGE SHIFT (IMAGES 1 - 4) THAT LED TO THE MISPLACEMENT OF SCREWS. THE PREOPERATIVE MERGE CAN BE MORE DIFFICULT DEPENDING ON THE QUALITY OF THE PREOPERATIVE CT SCAN, QUALITY OF THE DIGITAL RADIOGRAPHY (DR) IMAGES, AND PATIENT ANATOMY. IT CAN BE SEEN THROUGH THE CASE LOGS (IMAGES 1-2) THAT THE AP SHOT USED FOR THE L5 AND S1 CONTAINED A MERGE SHIFT. IT IS ALSO RECOMMENDED THAT THE USER SHOULD VERIFY REGISTRATION FOR EACH LEVEL PRIOR TO NAVIGATION. THE EXCELSIUSGPS SPINE MODULE USER MANUAL RECOMMENDS ALTERNATING BETWEEN THE CT SCAN IMAGES WITH THE PLANNED SCREWS AND THE 2D IMAGES WITH THE LEVEL INDICATOR AT EACH LEVEL TO CONFIRM PROPER REGISTRATION. AFTER REGISTRATION HAS BEEN COMPLETED, A LANDMARK CHECK OR VERIFICATION NEEDS TO BE PERFORMED TO ENSURE THAT THE REGISTRATION WAS SUCCESSFULLY CALCULATED. THE CAUSE OF THE REPORTED ISSUE CAN BE TRACED TO USER TECHNIQUE." }, { "mdr_text_key": "352967470", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM. THIS EVENT OCCURRED IN GERMANY." } ], "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": "09/17/2024" } ] }