{ "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": "3004142400-2025-00259", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251030", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20251017", "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": "EI", "manufacturer_contact_area_code": "610", "date_added": "20251030", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2745764", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20251030", "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": "6143.1002", "catalog_number": "", "lot_number": "GPS-0183", "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": "", "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", "Human-Device Interface Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251121", "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": "20251030", "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": "20251030", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "23424487", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20251022", "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": "383864891", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING THE SURGEON'S EGPS 1L L5/S1 PLIF ON A GRADE 1 SPONDYLOLISTHESIS PATIENT. THEY PLANNED PEDICLE SCREWS RELATIVELY STRAIGHT ON, AS HE INTENDED A MIDLINE INCISION. THE SURGEON APPROVED THE PLAN. THEY PLACED THE LONG QUATTRO SPIKE AND LONG SURVEILLANCE MARKER DUE TO PATIENT HYPERLORDOSIS, AND PERFORMED THE MERGE, WHICH WAS APPROVED. THEY BROUGHT IN THE ROBOT AND MARKED THE SKIN, BUT THE SURGEON SWITCHED TO MINI WILES INCISIONS. BETWEEN THE MERGE AND SCREW INSERTION, THE SURGEON BUMPED EITHER THE SM OR DRB TWICE, SHIFTING THE RED MARKER. HE VERIFIED NAVIGATION ACCURACY USING THE CHICKEN FOOT ALONG THE QUATTRO BASE, SM, AND SPINOUS PROCESS BEFORE RE-REGISTERING THE SM. THE RIGHT L5 SCREW FAILED TO PENETRATE THE POSTERIOR VB WALL, SO THEY PLACED RIGHT S1 FIRST TO CHECK DRILL SHARPNESS, THEN CHANGED TO A NEW DRILL. THE LEFT L5 AND S1 SCREWS WERE PLACED NEXT. THE POST-OP X-RAYS SHOWED LEFT L5 COMPLETELY OUT OF THE PEDICLE IN AP BUT PERFECT LATERALLY. THEY PERFORMED ANOTHER MERGE, APPROVED BY THE SURGEON, AND REPLACED LEFT L5." }, { "mdr_text_key": "383864892", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. WHILE UTILIZING EXCELSIUSGPS IT WAS REPORTED TO GLOBUS MEDICAL THAT THE IMPLANT AT L5-L WAS MISPLACED LATERAL TO THE INTENDED TRAJECTORY. AN INVESTIGATION OF THE CASE LOGS REVEALED THAT THE ROOT CAUSE WAS A COMBINATION OF DYNAMIC REFERENCE BASE (DRB) SHIFTS AND EXCESSIVE DEFLECTION FORCES DURING NAVIGATION. MOVEMENT OF THE DRB DURING NAVIGATION CAN LEAD TO A LOSS OF NAVIGATIONAL INTEGRITY AND MISPLACED IMPLANTS. THE CASE LOGS ALSO SHOWED THAT THE SOFTWARE DETECTED AND THEN ALERTED THE USER OF EXCESSIVE DEFLECTION FORCES ON THE END EFFECTOR, WHICH CAN INDICATE SKIVING. SKIVING CAN LEAD TO THE MISPLACEMENT OF IMPLANTS. ULTIMATELY, THE USER OPTED TO PERFORM A NEW PRE-OPERATIVE CT MERGE TO RE-REGISTER THE PATIENT, AND L5-L WAS REMOVED AND REPLACED. NO ADVERSE EFFECTS TO THE PATIENT WERE 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 DOES NOT EXCEED 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 WAS TRACED TO USER 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": "610", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }