{ "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": "3004142400-2026-00058", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260402", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20260304", "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": "20260402", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "831212", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20260402", "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-0363", "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": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260501", "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": "20260402", "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": "20260402", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "24765412", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260305", "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": "397268810", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. AN INVESTIGATION INTO THE CASE LOGS PROVIDED REVEALED THAT A REGISTRATION SHIFT WAS THE CAUSE OF THE MISPLACED IMPLANT. REGISTRATION SHIFTS CAN CAUSE A LOSS OF NAVIGATIONAL INTEGRITY AND CAN LEAD TO THE MISPLACEMENT OF IMPLANTS. THE USER MUST VERIFY THE INTRA-OPERATIVE REGISTRATION BEFORE PROCEEDING WITH NAVIGATION. THE USER ACKNOWLEDGES THAT THEY WILL PERFORM AN ANATOMICAL LANDMARK CHECK WITH EACH NEW INSTRUMENT OR LEVEL TO ENSURE NAVIGATIONAL INTEGRITY BEFORE PROCEEDING WITH NAVIGATION. ULTIMATELY, THE USER OPTED TO RE-REGISTER AND REPLACE THE MISPLACED IMPLANT INTRAOPERATIVELY WITH NAVIGATION AND NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED. THIS EVALUATION HAS BEEN COMPLETED VIA ASSOCIATED CASE LOGS AND THERE ARE NO ASSOCIATED WORK ORDER 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": "397268811", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AT AN EXCELSIUS GPS SURGERY, WE HAD A MISPLACED SCREW. IT WAS E3D INTRA-OP, MIS, CREO MIS IMPLANTS. THERE WAS A KYPHOPLASTY DONE BEFORE THE SPIN AT L1. THEN THE SCREWS PLANNED FOR T12 AND L2. THERE WAS A SPIN DONE AFTER KYPHOPLASTY. THE SCREWS PLANNED WITH THE SURGEON AND THE END EFFECTOR BROUGHT IN. WE WENT: HIGH SPEED BURR, PILOT DRILL, TAP, SCREW. THE FIRST SCREW DID NOT GIVE US A GREEN CHECK MARK. THE SURGEON DECIDED TO CHECK THE SCREW VIA FLUORO AND FOUND THAT IT WAS PLACED OUTSIDE OF THE PEDICLE. THE SCREW WAS REMOVED AND REPLACED IN AN APPROPRIATE POSITION IN PEDICLE AFTER A SECOND SPIN. THE NEUROMONITORING DID NOT DETECT ANY RISE IN NUMBERS FROM THE SCREW. THE PATIENT WAS SAID TO BE IN STANDARD RECOVERY FROM SURGERY. A RE-SPIN WAS DONE AND ALL FOUR SCREWS WERE PLACED ACCURATELY AND CONFIRMED VIA FLUORO." } ], "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": "" } ] }