{ "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": "3004142400-2025-00256", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251112", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20251015", "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": "UK", "manufacturer_contact_area_code": "610", "date_added": "20251112", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "119356", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20251112", "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-0479", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251211", "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": "20251112", "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": "20251112", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "23536268", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20251016", "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": "384983449", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. IT WAS REPORTED TO GLOBUS MEDICAL THAT THERE WERE MISPLACED IMPLANTS AT L2. THE REPRESENTATIVE DETAILED THAT UTILIZING THE PREOPERATIVE WORKFLOW THAT DURING NAVIGATION, THE USER PLACED SCREWS IN A SERPENTINE PATTERN WORKING FROM T10 TO L2. IT WAS ALSO DETAILED THAT THE END EFFECTOR WAS RESET ONTO TRAJECTORY SEVERAL TIMES FOR MULTIPLE SCREWS AND THAT THE USER PROCEEDED PLACING IMPLANTS REGARDLESS OF WHAT THE NAVIGATION INDICATED. AFTER REVIEW OF CASE LOGS, IT WAS FOUND THAT THE USER EXPERIENCED A DYNAMIC REFERENCE BASE (DRB) SHIFT BEFORE THE PLACEMENT OF THE L2-L SCREW. A SHIFT OF THE DRB CAN RESULT IN THE MISPLACEMENT OF IMPLANTS. THE SURGEON DECIDED AGAINST TAKING POST-OPERATIVE X-RAYS FOLLOWING SCREW PLACEMENT. THE MISPLACEMENT OF THE L2 SCREWS WAS DETERMINED AFTER A POST-OPERATIVE CT SCAN WAS CONDUCTED WHICH RESULTED IN SCHEDULING A SEPARATE REVISION SURGERY WHERE THE L2 SCREW WERE SUCCESSFULLY REVISED. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT. 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": "384983450", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM A SCREW WAS MISPLACED DURING A PROCEDURE WITH EGPS. THE SURGEON FOUND OUT VIA POST-OPERATIVE CT, BEFORE THIS THERE WAS NO AWARENESS THAT THERE HAD BEEN A MISPLACED SCREW. CASE WAS AN MIS TRAUMA STABILIZATION FOR T12 FRACTURE, T10, 11, L1 AND L2 INSTRUMENTS. THE SCREWS IN QUESTION WERE AN L2 RIGHT PEDICLE SCREW, BREACHING MEDIALLY AND AN L2 LEFT PEDICLE SCREW BREACHING LATERALLY. SURGEON STATED THAT PATIENT DIDN'T EXHIBIT ANY NEUROLOGICAL DEFICIT HOWEVER THE SCREWS NEEDED TO BE REVISED. WE JUST COMPLETED REVISION SURGERY AND CONFIRMED CORRECT PLACEMENT OF L2 SCREWS AND EXTENDING DOWN TO L3. SCREW PLACEMENT CONFIRMED WITH INTRA-OPERATIVE CONE BEAM CT. SURGEON WAS UNSURE AND WASN'T ABLE TO POINT SPECIFICALLY TO ANY SIGNIFICANT EVENT E.G. FRAME SHIFT THAT WOULD HAVE CONTRIBUTED TO THE DEVIATION, SHE STATED THAT THE PATIENT HAD VERY SCLEROTIC BONE AND TISSUE AND THIS MAY HAVE MECHANICALLY PULLED THE SCREWS OFF COURSE, SHE STATED THAT INSERTING THE SCREWS WAS \"TOUGH\" AND WAS CONSTANTLY FIGHTING FORCES. THE PATIENT ALSO HAD VERY NARROW PEDICLES, AND INSTRUMENTATION WAS GOING TO BE CHALLENGING IN ANY SCENARIO. I WASN'T PRESENT IN THE PRIMARY PROCEDURE BUT WAS PRESENT FOR THE REVISION." } ], "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": "" } ] }