{ "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": "3004142400-2025-00283", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251121", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20250710", "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": "20251121", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "905935", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20251121", "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-0371", "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": "GA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251223", "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": "20251121", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Spinal Column Injury", "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20251121", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "23617138", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20251111", "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": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "385751180", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE SURGERY WAS PERFORMED AT THE L3-4 SITE, INSTEAD OF THE L3-5 SITE. THIS WAS NOT DISCOVERED DURING THE SURGERY OR DURING THE PATIENT'S STAY IN THE HOSPITAL. UPON THE PATIENT'S RETURN VISIT, HE WAS ADVISED BY THE SURGEON THAT THE SURGERY WAS PERFORMED AT THE WRONG LEVEL. AN ADDITIONAL SURGERY AT THE CORRECT SITE WAS SCHEDULED FOR ON (B)(6) 2025. THE PATIENT CLAIMS TO HAVE SEVERE PAIN, DIFFICULTY IN AMBULATING AND FOOT DROP." }, { "mdr_text_key": "385751181", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ENGINEERING EVALUATION WAS UNABLE TO VERIFY A SYSTEM MALFUNCTION DUE TO INSUFFICIENT INFORMATION AS THE USER DID NOT SUBMIT CASE LOGS FOR INVESTIGATION . IT WAS REPORTED THAT THE PATIENT UNDERWENT SCHEDULED SURGERY AT THE L4-L5 VERTEBRAL SITE AT BURKE HEALTH WITH THE USE OF EXCELSIUSGPS. THE SURGERY WAS PERFORMED ON THE L3-L4 SITE INSTEAD OF THE L4-L5 SITE AND THE DISCREPANCY WAS NOT DISCOVERED DURING THE SURGERY. IN A FOLLOW UP PATIENT VISIT, IT WAS FOUND THAT THE SURGERY WAS PERFORMED AT THE WRONG LEVEL (AT THE L3-L4 SITE). IT IS RECOMMENDED TO PAIR THE SM TO THE DRB BEFORE THE PROCEDURE BEGINS, AS THE SOFTWARE WILL BE ABLE TO ALERT THE USER OF ANY DRB SHIFTS. DURING THE PRE-OPERATIVE REGISTRATION AND AFTER THE REGISTRATION HAS BEEN COMPLETED, USERS SHOULD PERFORM A LANDMARK CHECK OR VERIFICATION TO ENSURE THE REGISTRATION HAS BEEN SUCCESSFULLY CALCULATED . IT IS ALSO ADVISABLE TO MONITOR THE PATIENT MOVEMENT BAR, AS THIS TRACKS MOVEMENT OF THE DRB WITH RESPECT TO THE FLUOROSCOPY REGISTRATION FIXTURE . WHEN NAVIGATING ON THE NAVIGATE TAB, MAKE SURE TO MONITOR THE SIGNIFICANT MOVEMENT OF THE DRB, THEN PERFORM AN ANATOMICAL LANDMARK CHECK . IF THE LANDMARK CHECK IS SATISFACTORY, RE-REGISTER LANDMARK CHECK FAILS, RE-REGISTER THE PATIENT . IN ADDITION TO MONITORING THE DRB, ATTENTION SHOULD ALSO BE GIVEN TO INSTRUMENT HANDLING. EXCESSIVE FORCE ON THE END EFFECTOR IS LIKELY THE RESULT OF INSTRUMENT SKIVING THAT WAS DETECTED WHILE A TOOL IS INSERTED INTO THE END EFFECTOR. SKIVING CAN LEAD TO THE MISPLACEMENT OF SCREWS. ULTIMATELY, A REVISION SURGERY WAS SCHEDULED AND PERFORMED . IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, DIFFICULTY IN AMBULATING, AND FOOT DROP. 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." } ], "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": "" } ] }