{ "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": "3004142400-2025-00120", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20250603", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20250408", "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": "20250603", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2639968", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20250603", "brand_name": "EXCELSIUS ROBOTICS SYSTEM", "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": "", "model_number": "6143.1001", "catalog_number": "", "lot_number": "GPS-0363", "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": "00088909548129", "udi_public": "0088909548129", "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": "04/09/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250807", "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": "20250603", "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": "20250702", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "22135749", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250409", "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": "371661462", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE CASE LOGS HAVE NOT BEEN REVIEWED FOR EVALUATION. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE." }, { "mdr_text_key": "371661463", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED." }, { "mdr_text_key": "376654150", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. REVIEW OF THE CASE LOGS AND INTRA-OPERATIVE CT IMAGING INDICATED THAT THE MISPLACEMENT OF THE IMPLANT WAS LIKELY DUE TO A PLANNING ERROR WHILE UTILIZING EXCELSIUSGPS. THE L5-R IMPLANT WAS A 45MM LENGTH SCREW PROVIDED BY A COMPETITIVE IMPLANT COMPANY AS WERE THE OTHER THREE IMPLANTS THAT WERE PLACED FOR THIS PROCEDURE. THE PROVIDED INTRA-OPERATIVE IMAGING CONTAINED THE MISPLACED IMPLANT AND WHEN EVALUATED, THE L5-R IMPLANT WAS SHOWN TO BE 45MM IN LENGTH COMPARED TO THE 35MM IMPLANT OF THE OPPOSING SIDE AND 40MM LENGTHS OF THE SUPERIOR L4 IMPLANTS. VISUALIZING THE PLAN OF THE L5-R 45MM IMPLANT INDICATES THAT THE SELECTED LENGTH WAS TOO LONG FOR THE PLANNED TRAJECTORY AND THAT A 35MM IMPLANT SIMILAR TO THE OPPOSING SIDE WOULD LIKELY HAVE BEEN THE BEST LENGTH FOR THIS TRAJECTORY AS A 40MM IMPLANT WAS ALSO SHOWN TO LIKELY BREACH ANTERIORLY ON THE VERTEBRAL BODY. USING THE PROVIDED INFORMATION, OUR INVESTIGATION CONCLUDED THAT A PLANNING ERROR IN THE SIZING OF THE IMPLANT TO USE WAS THE ROOT CAUSE OF THE MISPLACEMENT. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED DUE TO THE ANTERIORLY BREACHED IMPLANT AT L5-R AND THE USER OPTED TO LEAVE IT IN PLACE. THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH DOES NOT MATCH 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED FOR THIS SUPPLEMENTAL REPORT: B4; G6; H1; H2; H3; H6; H10." }, { "mdr_text_key": "376654151", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED." } ], "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": "07/02/2025" } ] }