{ "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": "3004142400-2026-00044", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260310", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20230620", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "19403", "reporter_occupation_code": "PHYSICIAN", "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": "", "date_added": "20260310", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "618523", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20260310", "brand_name": "EXCELSIUS GPS", "generic_name": "ROBOT, SURGICAL, NAVIGATION UNIT", "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-0207", "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": "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" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260327", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260310", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20260310", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "24557062", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260209", "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": "395097049", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT UNDERWENT SCHEDULED SURGERY ON (B)(6) 2023 AT THE L2-S1 VERTEBRAL SITE WITH THE USE OF EXCELSIUSGPS. DURING THE PROCEDURE, THE IMPLANTS USED AT T10-T12 WERE NOT THE SIZE THAT WERE ORIGINALLY SPECIFIED FOR USAGE (5.5 MM X 40 MM). DURING THE POST-OPERATIVE PERIOD ON (B)(6) 2023, A COMPRESSION FRACTURE AT T10 WAS DISCOVERED, LEADING TO AN IMMEDIATE REVISION SURGERY TO REVISE THE IMPLANTED HARDWARE. ENGINEERING EVALUATION WAS UNABLE TO VERIFY A SYSTEM MALFUNCTION DUE TO INSUFFICIENT INFORMATION AS THE USER DID NOT SUBMIT CASE LOGS FOR INVESTIGATION. DURING THE PRE-OPERATIVE REGISTRATION AND AFTER THE REGISTRATION HAS BEEN COMPLETED, USERS SHOULD PERFORM A LANDMARK CHECK OR VERIFICATION TO ENSURE THE REGISTRATION HAS BEEN SUCCESSFULLY CALCULATED. IT IS ALSO ADVISABLE TO MONITOR THE PATIENT MOVEMENT BAR, AS THIS TRACKS MOVEMENT OF THE DYNAMIC REFERENCE BASE (DRB) WITH RESPECT TO THE FLUOROSCOPY REGISTRATION FIXTURE. WHEN NAVIGATING ON THE NAVIGATE TAB, MAKE SURE TO MONITOR THE SURVEILLANCE MARKER DURING THE PROCEDURE, AND IF THE SURVEILLANCE MARKER INDICATES SIGNIFICANT MOVEMENT OF THE DRB, THEN PERFORM AN ANATOMICAL LANDMARK CHECK. IF THE LANDMARK CHECK IS SATISFACTORY, RE-REGISTER THE SURVEILLANCE MARKER, BUT IF THE LANDMARK CHECK FAILS, RE-REGISTER THE PATIENT. IN ADDITION TO MONITORING THE DRB, ATTENTION SHOULD ALSO BE GIVEN TO INSTRUMENT HANDLING. EXCESSIVE FORCE ON THE END EFFECTOR IS LIKELY THE RESULT OF INSTRUMENT SKIVING THAT WAS DETECTED WHILE A TOOL IS INSERTED INTO THE END EFFECTOR. SKIVING CAN LEAD TO THE MISPLACEMENT OF SCREWS. ULTIMATELY, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT CLAIMS TO HAVE EXPERIENCED PARAPLEGIA AND DECREASED MOVEMENT IN BILATERAL FEET. THE EVENT SEVERITY OBSERVED DID NOT EXCEED THE ANTICIPATED SEVERITY. 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." }, { "mdr_text_key": "395097050", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A SURGERY ON (B)(6) 2023 UTILIZING THE EXCELSUS GPS THE PATIENT EXPERIENCED EXTREME PAIN AND DECREASED MOVEMENT IN THEIR LEGS. ON (B)(6) 2023 MRI SCANS REVEALED A COMPRESSION FRACTURE OF T10. REVISION WAS PERFORMED URGENTLY TO DECOMPRESS THE SITE AND REVISE THE HARDWARE SURROUNDING IT." } ], "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": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }