{ "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": "", "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": "3004142400-2026-00083", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260501", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20260401", "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": "20260501", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "507688", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20260501", "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-0585", "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": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260707", "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": "20260501", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20260501", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "25057896", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260402", "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": "400089500", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. ANY APPLICABLE PARTS WILL BE RETURNING TO THE METHUEN IMAGING, NAVIGATION & ROBOTICS (INR) SITE AND PROCESSED PER WI-BS-0031 NONCONFORMANCE WORK INSTRUCTION. AN INVESTIGATION INTO THE CASE LOGS REVEALED THE ROOT CAUSE WAS EXCESSIVE DEFLECTION FORCES, OR SKIVING DURING NAVIGATION. THE SOFTWARE CORRECTLY DETECTED AND ALERTED THE USER OF HIGH DEFLECTION FORCES PRESENT ON THE LOAD CELL DURING BONE WORK. THIS EXCESSIVE FORCE PRESENT ON THE LOAD CELL IS LIKELY THE RESULT OF INSTRUMENT SKIVING THAT WAS DETECTED WHILE A TOOL WAS INSERTED INTO THE END EFFECTOR. ULTIMATELY, THE USER OPTED TO REPLACE THE MISPLACED IMPLANT USING ANOTHER NAVIGATION SYSTEM WITH NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THIS EVALUATION HAS BEEN COMPLETED, AND THERE ARE NO ASSOCIATED WORK ORDERS OR PART RETURNS. THE 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. THE CAUSE OF THE REPORTED ISSUE CAN BE TRACED TO USER TECHNIQUE." }, { "mdr_text_key": "400089501", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, AN L1-L3 FUSION OCCURRED AT AN ACCOUNT THAT HAS REPORTED PREVIOUS PROBLEMS WITH THE ROBOT MISSING SCREWS. FSE CAME OUT LAST WEEK AND FOUND THAT THE CAMERA WAS OUT OF SPEC. CUSTOM PERC IN WAS PLACED IN PSIS, AND DRB AND SM WERE ATTACHED TO THE SAME POST. THE WORKFLOW WAS HIGH-SPEED BURR, STRAIGHT PEDICLE PROBE TAP, AND DRIVER. NAVIGATION SHOWED PERFECT PLACEMENT OF SCREW-DOWN PEDICLE. WHEN MOVING TO THE RIGHT L1 TRAJECTORY, THE SURGEON REPORTED THAT THE TACTILE FEEL WITH THE PEDICLE PROBE DIDN'T FEEL RIGHT AND WANTED TO DO ANOTHER SPIN WITH E3D. UPON TAKING OUR FIRST AP SCOUT SHOT TO PREPARE FOR SPIN, WE SAW THAT THE FIRST SCREW AT LEFT L1 WAS COMPLETELY LATERAL TO THE PEDICLE. A NEW SPIN WITH E3D WAS DONE, AND WE COULD SEE THE TRAJECTORY OF THE RIGHT L1 SCREW THAT WE WERE WORKING ON WAS LATERAL AND SUPERIOR WITH O-ARM AND MEDTRONIC STEALTH. IN THE PREVIOUS CASES, WHERE MISSED SCREWS WERE REPORTED, THE ROBOT PLACED SCREWS VERY SIMILARLY TO HOW WE OBSERVED IN THIS CASE. NO DRB SHIFTS WERE OBSERVED BY THE ROBOT OR THE SURGICAL TEAM." } ], "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": "" } ] }