{ "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": "3004142400-2026-00009", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260105", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20251105", "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": "20260105", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "27947", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20260105", "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-0348", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "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": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/17/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260508", "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": "20260105", "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": "20260218", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "23959764", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20251106", "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": "389278855", "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." }, { "mdr_text_key": "389278856", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING AN EXCELSIUSGPS SURGERY THE FIRST SCREW LOOKED TO PLAN. THE SECOND SCREW, L4R, LOOKED LIKE IT WAS TO PLAN, BUT THE OFFSET WAS RED, AND DOC WAS WORRIED. THERE WERE NO NAV SHIFTS AFTER LANDMARK CHECK. HE DIDN'T LIKE, CAME BACK IN WITH DURA PRO, PUT IN SCREW AGAIN, BUT THIS TIME WAS LATERAL. HE DID A LANDMARK CHECK, EVERYTHING ACCURATE. HE DID THE SCREW FREEHAND NAV, WHICH WAS TO PLAN. THE L4L SCREW OFFSET WAS RED, AND SCREW LOOKED LATERAL, BUT DOC SAID THAT IT FELT GOOD TO HIM AND DURA PRO WAS GREEN AND RIGHT ON TRAJECTORY. THE SCREW WAS LATERAL. IT WAS POSSIBLY LATERAL DUE TO RETRACTOR, OR PATIENT MOVEMENT. THE DR. (B)(6) TOOK OUT SCREW, AND REPLACED SCREW FREEHAND WITHOUT NAVIGATION USING FLOUROSCOPY. ALL SCREWS TO PLAN AT END." }, { "mdr_text_key": "395031245", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. IT WAS REPORTED THAT IMPLANTS AT L4 WERE MISPLACED. CASE LOGS WERE NOT PROVIDED, SO A FORMAL INVESTIGATION COULD NOT BE COMPLETED. HOWEVER, THE GLOBUS MEDICAL REPRESENTATIVE REPORTED THAT THERE WAS PATIENT MOVEMENT DURING PLACEMENT. PATIENT MOVEMENT CAN CAUSE DYNAMIC REFERENCE BASE (DRB) SHIFTS TO OCCUR. DRB SHIFTS CAN RESULT IN A LOSS OF NAVIGATIONAL INTEGRITY. AFTER THE REGISTRATION HAS BEEN COMPLETED, IT IS RECOMMENDED TO PERFORM A LANDMARK CHECK OR VERIFICATION TO ENSURE THAT THE REGISTRATION WAS SUCCESSFULLY CALCULATED. USING THE NAVIGATED VERIFICATION PROBE, TOUCH AN ANATOMICAL LANDMARK AND VERIFY THAT THE CORRESPONDING LOCATION IS SHOWN ON THE SYSTEM MONITOR. ULTIMATELY, THE USER OPTED TO REPLACE THE IMPLANTS AT L4-L AND L4-R WITH TRADITIONAL METHODS AND THE CASE WAS COMPLETED WITH NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THIS EVALUATION HAS BEEN COMPLETED VIA ASSOCIATED CASE LOGS AND THERE ARE NO ASSOCIATED WORK ORDER OR PART RETURNS. THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH MATCHES THE OBSERVED ANTICIPATED RISK LEVEL; THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED. THE CAUSE OF THE REPORTED ISSUE CAN BE TRACED TO USER TECHNIQUE. THE FOLLOWING SECTIONS WERE UPDATED FOR THIS SUPPLEMENTAL REPORT: B4, G3, G6, H2, H3, H6, H10." }, { "mdr_text_key": "395031246", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING AN EXCELSIUSGPS SURGERY THE FIRST SCREW LOOKED TO PLAN. THE SECOND SCREW, L4R, LOOKED LIKE IT WAS TO PLAN, BUT THE OFFSET WAS RED, AND DOC WAS WORRIED. THERE WERE NO NAV SHIFTS AFTER LANDMARK CHECK. HE DIDN'T LIKE, CAME BACK IN WITH DURA PRO, PUT IN SCREW AGAIN, BUT THIS TIME WAS LATERAL. HE DID A LANDMARK CHECK, EVERYTHING ACCURATE. HE DID THE SCREW FREEHAND NAV, WHICH WAS TO PLAN. THE L4L SCREW OFFSET WAS RED, AND SCREW LOOKED LATERAL, BUT DOC SAID THAT IT FELT GOOD TO HIM AND DURA PRO WAS GREEN AND RIGHT ON TRAJECTORY. THE SCREW WAS LATERAL. IT WAS POSSIBLY LATERAL DUE TO RETRACTOR, OR PATIENT MOVEMENT. THE DR. TOOK OUT SCREW, AND REPLACED SCREW FREEHAND WITHOUT NAVIGATION USING FLOUROSCOPY. ALL SCREWS TO PLAN AT END." } ], "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": "02/18/2026" } ] }