{ "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": "3004142400-2024-00344", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250130", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20220726", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "19403", "reporter_occupation_code": "003", "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": "20250130", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "406953", "implant_date_year": "2022", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20250130", "brand_name": "EXCELSIUS GPS", "generic_name": "SYSTEM, EXCELSIUS GPS, 120V", "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-0313", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250822", "health_professional": "", "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": "20250130", "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": "20250130", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "21273932", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250129", "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": "362505200", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS IS BEING REPORTED FOR A PROBLEM FOUND EARLIER. INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. THE PRE-OPERATIVE MERGE CAN BE IMPACTED BY SUCH FACTORS AS QUALITY OF THE PRE-OPERATIVE CT, QUALITY OF THE FLUOROSCOPIC IMAGES, SURGICAL PLAN, AND PATIENT ANATOMY. CASE INVESTIGATION REVEALED THAT MOST LEVELS HAD GOOD REGISTRATION, AND THE LEVELS WHERE THERE WAS NOT A SATISFACTORY MERGE HAD SHOTS WITH TRACKING ERRORS. SUGGESTED TROUBLESHOOTING MEASURES FOR THE USER WOULD BE TO TRY DIFFERENT SHOTS AND REGISTRATION TYPES, RE-ASSIGN CENTROID POSITIONS, TAKE TRUER AP AND LAT SHOTS, AND ADJUST BRIGHTNESS/CONTRAST OF THE FLUOROSCOPIC IMAGES. THE OBSERVED SEVERITY DID NOT EXCEED THE ANTICIPATED SEVERITY. THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH IS LOWER THAN THE 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": "362505201", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE CASE WAS SCHEDULED AS PREOP CT WORKFLOW FOR POSTERIOR PERCUTANEOUS SCREW PLACEMENT WITH THE ROBOT AT L4 AND L5 FOLLOWING AN L4/5 LLIF. THE SCAN UPLOADED WITH NO ISSUES AND WAS CONFIRMED TO BE TO PROTOCOL. THE SURGEON PLANNED SCREWS AT L4 AND L5 WHILE THE PATIENT WAS REPOSITIONED PRONE. DRB AND SM WERE PLACED IN PSIS IN STANDARD ORIENTATION WITH CAMERA AT THE FOOT. THE SM WAS REGISTERED PRIOR TO X-RAY COMING INTO THE FIELD. IMAGES WERE INITIALLY OBTAINED FOR L4 AND L5, BUT THE MERGE WAS UNSUCCESSFUL - WAGGING UP AND DOWN IN THE LATERAL IMAGES AND SLIGHT ROCKING IN THE AP. L3 AND S1 WERE ADDED IN THE WORKFLOW PAGE AND \"DUMMY\" SCREWS WERE QUICKLY PLANNED AT L3 AND S1. IMAGES WERE OBTAINED FOR L3 AND S1 WITH THE SAME RESULT - UNSUCCESSFUL MERGE WITH WHAT SEEMED LIKE EQUAL MOVEMENT WHEN VERIFYING. NEW SHOTS WERE THEN OBTAINED FOR L4 AND L5 AND ONCE AGAIN WE COULD NOT GET A MERGE, WE WERE CONFIDENT IN ACCEPTING. THE SURGEON BAILED TO TRADITIONAL JAMSHID PLACEMENT, ALREADY FRUSTRATED WITH HIS EXPERIENCES OF THE DAY, ALTHOUGH FLUORO WORKFLOW WAS OFFERED TO HIM." } ], "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": "" } ] }