{ "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": "N", "manufacturer_contact_t_name": "", "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": "3004142400-2026-00085", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260423", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20260407", "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": [ "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "19403", "manufacturer_g1_state": "PA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "", "date_added": "20260423", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "117935", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260423", "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-0568", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "DAY", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/07/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260903", "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": "20260423", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "64 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "White", "patient_problems": [ "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20260520", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "24971682", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260407", "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": "399343308", "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": "399343309", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AT AN EXCELSIUSGPS SURGERY, IT WAS AN SPL CASE INVOLVING T12-L2, WITH A CORPECTOMY AT L1. THE INTRAOPERATIVE CONTROL X-RAYS DID NOT SHOW ANY VISIBLE SCREW MALPOSITION, AND THE SURGEONS PROCEEDED WITH THE SURGERY. HOWEVER, THE POSTOPERATIVE CT SCAN REVEALED THAT THE RIGHT L2 SCREW WAS PLACED MORE LATERALLY THAN INITIALLY PLANNED. ORIGINALLY, THE SCREW HAD BEEN PLANNED USING AN IN-OUT-IN TECHNIQUE DUE TO THE SMALL PEDICLE. FOLLOWING THE CT SCAN RESULTS, REVISION SURGERY WAS PERFORMED, AND THE SCREW WAS REPOSITIONED USING THE TRADITIONAL TECHNIQUE." }, { "mdr_text_key": "16141465936", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. IT WAS REPORTED THAT AN IMPLANT AT L2-R WAS MISPLACED LATERALLY DURING AN INTRA-OPERATIVE PROCEDURE. FURTHER, IT WAS REPORTED THAT THE SCREW WAS PLANNED USING AN IN-OUT-IN TECHNIQUE DUE TO THE SMALL PEDICLE. AN INVESTIGATION INTO THE PROVIDED CASE AND TRACKING LOGS REVEALED THAT THE ROOT CAUSE WAS A COMBINATION OF IMPLANT PLAN PLACEMENT AND SHALLOW PILOT HOLE PRIOR TO PLACEMENT OF THE IMPLANT. THE INVESTIGATION SHOWED THAT THE PILOT HOLE WAS INSUFFICIENTLY DRILLED ALONG THE LENGTH OF THE IN-OUT-IN TRAJECTORY SUCH THAT WHEN THE IMPLANT WAS PLACED, THE TIP OF THE IMPLANT WAS UNABLE TO GET PURCHASE IN THE BODY, LEADING TO SKIVE. SKIVING CAN LEAD TO THE MISPLACEMENT OF IMPLANTS. ULTIMATELY, THE USER OPTED TO REPLACE THE MISPLACED IMPLANT USING THE TRADITIONAL METHODS 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. THE FOLLOWING SECTIONS WERE UPDATED FOR THIS SUPPLEMENTAL REPORT:B4, G3, G6, H2, H3, H6, H10." }, { "mdr_text_key": "15641465935", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AT AN EXCELSIUSGPS SURGERY, IT WAS AN SPL CASE INVOLVING T12-L2, WITH A CORPECTOMY AT L1. THE INTRAOPERATIVE CONTROL X-RAYS DID NOT SHOW ANY VISIBLE SCREW MALPOSITION, AND THE SURGEONS PROCEEDED WITH THE SURGERY. HOWEVER, THE POSTOPERATIVE CT SCAN REVEALED THAT THE RIGHT L2 SCREW WAS PLACED MORE LATERALLY THAN INITIALLY PLANNED. ORIGINALLY, THE SCREW HAD BEEN PLANNED USING AN IN-OUT-IN TECHNIQUE DUE TO THE SMALL PEDICLE. FOLLOWING THE CT SCAN RESULTS, REVISION SURGERY WAS PERFORMED, AND THE SCREW WAS REPOSITIONED USING THE TRADITIONAL TECHNIQUE." } ], "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": "05/20/2026" } ] }