{ "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": "3004142400-2025-00240", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251022", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20250924", "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": "610", "date_added": "20251022", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2443057", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20251022", "brand_name": "EXCELSIUS ROBOTICS SYSTEM", "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-0573", "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", "Human-Device Interface Problem" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251117", "health_professional": "Y", "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": "20251022", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "43 YR", "patient_sex": "Male", "patient_weight": "108 KG", "patient_ethnicity": "", "patient_race": "White", "patient_problems": [ "Spinal Column Injury", "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20251022", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "23360337", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250925", "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": "383229830", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DR. (B)(6) USED THE EXCELSIUS ROBOT (INTRA-OP WORKFLOW) FOR A T11-L1 POSTERIOR LATERAL FUSION. IT IS TO BE NOTED HE ONLY PLACED PEDICLE SCREWS AT T11AND L1 SKIPPING T12 DUE TO A TUMOR SURROUNDING THE T12 VERTEBRAL BODY. DR. (B)(6) DECIDED TO PERFORM HIS DECOMPRESSION THROUGH A POSTERIOR MIDLINE INCISION PRIOR TO PLACING PEDICLE SCREWS BECAUSE HE WANTED TO KNOW HOW FAR THE TUMOR HAD SPREAD. DR. (B)(6) WANTED TO USE THE DRB AND SURVEILLANCE MARKER AND PLACED THEM IN THE PSIS AFTER DECOMPRESSION. AFTER SCREWS WERE PLACED AND ANOTHER CT SCAN WAS PERFORMED VIA E3D THE PEDICLE SCREWS ON THE PATIENT'S RIGHT SIDE WERE MEDIAL OF THE PLANNED TRAJECTORY. LEFT PEDICLE SCREWS WERE IN THE PROPER TRAJECTORY. SURVEILLANCE SHOWED THAT THE DRB HAD NOT MOVED DURING THE CASE. DR. HAMILTON REMOVED THE RIGHT SCREWS AND IMPLANTED THEM FREEHAND. HE ADVISED HE DID NOT SEE ANY DURAL LEAKS AND LATER TOLD US THE PATIENT WAS DOING WELL." }, { "mdr_text_key": "383229831", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. WHILE UTILIZING EXCELSIUSGPS IT WAS REPORTED TO GLOBUS MEDICAL THAT BOTH IMPLANTS AT T11-R AND L1-R WERE REMOVED AND REPLACED. AN INVESTIGATION OF THE CASE LOGS REVEALED THAT THE ROOT CAUSE WAS DUE TO A SHIFT IN THE ANATOMY THAT OCCURRED DURING IMPLANT PLACEMENT. THE POST-OPERATIVE SCAN PROVIDED ALLOWED US TO VISUALIZE THE PLACEMENT OF IMPLANTS DURING THE PROCEDURE. THE RIGHT SIDE IMPLANTS WERE BOTH MISPLACED MEDIALLY TO A LARGER DEGREE THAN THE LEFT SIDE IMPLANTS. WHEN PLACING THE RIGHT SIDE IMPLANTS, THE USER REMAINED ON THE LEFT SIDE OF THE PATIENT AND PULLED THE INSTRUMENTATION MEDIALLY TOWARDS THEM. THIS TENSION CAN CAUSE MINOR SHIFTS IN THE ANATOMY, RESULTING IN BOTH RIGHT-SIDE IMPLANTS BEING MISPLACED MEDIALLY. ULTIMATELY, THE USER ABORTED USAGE OF EXCELSIUSGPS AND REPLACED THE MISPLACED IMPLANTS USING TRADITIONAL METHODS WITH NO ADVERSE EFFECT TO THE PATIENT. THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH DOES NOT EXCEED 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." } ], "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": "" } ] }