{ "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": "2026-10-07", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "N", "manufacturer_contact_t_name": "", "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": "3004142400-2026-00130", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260630", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20260601", "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": [ "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "19403", "manufacturer_g1_state": "PA", "reporter_country_code": "AS", "manufacturer_contact_area_code": "", "date_added": "20260630", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "181749", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260630", "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": "", "model_number": "6143.1001", "catalog_number": "", "lot_number": "GPS-0530", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260922", "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": "20260630", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "68 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20260630", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "25669131", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260601", "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": "406049115", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING AN EXCELSIUS GPS L3-5 PRONE XLIF WITH RISE-L AND RELINE SCREWS. THE DRB PLACED IN LEFT PSIS, SM IN RIGHT PSIS. THE E3D REGISTRATION SCAN, AND PLANNING WAS DONE BY THE SURGEON. WE STARTED ON LEFT L3, HIGH SPEED DRILL APPEARED ACCURATELY ON PEDICLE AS EXPECTED. PILOT DRILL THEN HAD TROUBLE DRILLING FULL DEPTH. THE SCREW IMPLANTED WITHOUT FULLY DRILLING PILOT HOLE THE RIGHT L3 SCREW PLACED QUICKLY BY THE SURGEON. WE NOTICED THAT THE HIGH SPEED DRILL APPEARED SLIGHTLY INACCURATE SO WE ASKED THE SURGEON TO CHECK ACCURACY ON BONE. AS THE PROCEDURE WAS MIS WE CHECKED ON THE LEFT L3 BONE, WHICH AGAIN APPEARED ACCURATE. WE PLACED LEFT L4 SCREW WHICH AGAIN APPEARED ACCURATE, BUT HAD THE SAME ISSUE WITH DRILLING DEPTH. WE THEORISED THAT PILOT DRILL WAS A LITTLE BLUNT, AND SOME VISIBLE SCLEROSIS IN THE LEFT PEDICLES MIGHT BE CAUSING ISSUES. WE WENT TO RIGHT L4 AND AGAIN SAW THE SAME INACCURACY AS AT RIGHT L3. THIS TIME WE STOPPED THE CASE AND RESCANNED. THE SCAN FOUND THAT LEFT L3 AND L4 HAD BREACHED MEDIALLY BY A FEW MM. THE RIGHT L3 APPEARED WELL PLACED. WE EXPLANTED LEFT SIDE L3-4 SCREWS, PLACED ALL SO-FAR UNPLACED SCREWS, THEN RE-IMPLANTED LEFT L4 AND L3. THE POST OP SCAN FOUND THAT LEFT L3 WAS STILL SLIGHTLY MEDIAL DUE TO DEVIATING INTO PREVIOUS PATH, BUT ACCEPTABLE. ALL OTHER SCREWS WELL PLACED. THE RISE-L CAGES PLACED AT L3-4 AND L4-5 WITHOUT ISSUE." }, { "mdr_text_key": "406049116", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE WAS UNAVAILABLE FOR EVALUATION. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE." } ], "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": "" } ] }