{ "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": "3004142400-2024-00377", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250123", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20221020", "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": "20250123", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1125657", "implant_date_year": "2022", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20250123", "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-0344", "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": "20250123", "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": "20250122", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "21217193", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240114", "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": "361950130", "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. AN INVESTIGATION OF THE CASE LOGS REVEALED THAT THE SOFTWARE DETECTED AND THEN ALERTED THE USER OF EXCESSIVE DEFLECTION DURING SCREW PLACEMENT, WHICH CAN BE CAUSED BY SKIVING. EXCESSIVE FORCE AND SKIVING CAN LEAD TO THE MISPLACEMENT OF SCREWS. ADDITIONALLY, IT WAS NOTED THAT THE USER PLACED THE LEFT-SIDED SCREWS BEFORE PLACING THE RIGHT-SIDED SCREWS. FOR ROBOTICS CASES, IT IS RECOMMENDED THAT THE USER PLACES SCREWS IN A SERPENTINE PATTERN MOVING TOWARDS THE DRB TO LIMIT CHANGES IN PATIENT ANATOMY RELATIVE TO THE DRB FOR MULTI-LEVEL SURGERY. THE SCREW WAS REPLACED USING TRADITIONAL TECHNIQUES INTRAOPERATIVELY AND NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED. 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": "361950131", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THIS EVENT OCCURRED IN AN INTRA-OP T10-PELVIS REVISION CASE. EXISTING HARDWARE WAS PRESENT FROM L3-S1. AFTER ALL STEPS OF THE INTRA-OP WORKFLOW HAD BEEN COMPLETED, A THOROUGH AND DETAILED ANATOMY CHECK WAS DONE. THE SURGEON AND HIS FELLOW ADJUSTED ALL SCREWS THAT HAD BEEN PRELIMINARILY PLANED. AFTER THE SURGEONS MODIFIED, REVIEWED, AND APPROVED ALL SCREWS; THE ROBOT WAS PUSHED INTO THE CORRECT POSITION. SCREWS WERE PLACED T10-L2 ON THE LEFT PRIOR TO PLACING SCREWS T10-L2 ON THE RIGHT (SURGEON PREFERENCE). S2AI SCREWS WERE PLACED LAST. ACCURACY CHECKS WERE CONDUCTED THROUGHOUT THE SCREW PLACEMENT PROCESS A SPIN WAS CONDUCTED AFTER ALL SCREWS WERE PLACED. THE LEFT T10 SCREW APPEARED TO BREACH THE MEDIAL WALL OF THE PEDICLE AND THE SCREW APPEARED SLIGHTLY MEDIAL TO THE PLAN. THE EXTENT OF THE BREACH COULD NOT BE DETERMINED DUE TO THE SCAN QUALITY (VERY POOR DUE TO THE PATIENT SIZE AND METAL SCATTER). THE SURGEON CAREFULLY REVIEWED THE SCREW AND NEURO MONITORING DATA BEFORE DECIDING TO LEAVE IT IN PLACE. THE LEFT T10 PEDICLE WAS SMALL, AND THE SURGEON SELECTED A SCREW DIAMETER THAT WAS CLINICALLY APPROPRIATE AND HIM EFFECTIVE FIXATION. THE SURGEON FELT IT WAS POSSIBLE THAT THE 4.5 HIGH SPEED BURR SKIVED SLIGHTLY AND/OR TOOK OUT A SMALL PORTION OF THE MEDIAL WALL. THIS WAS CAUGHT INITIALLY AND WAS APPROPRIATELY CORRECTED BEFORE PROCEEDING WITH SCREW PREP. A FEELER/SOUNDER WAS USED PRIOR TO PLACING THE SCREW AND A NOTICEABLE BREACH WAS NOT DETECTED. THE POST OP SPIN ALSO SHOWED THE RIGHT L1 SCREW WAS LATERAL TO THE PLAN AND PEDICLE. THE RIGHT L1 PEDICLE WAS SMALL AND THE SURGEON PLANED A CLINICALLY APPROPRIATE SCREW WITH A DIAMETER THAT WOULD PROVIDE THE MOST EFFECTIVE FIXATION. IT IS POSSIBLE THAT A SLIGHT SKIVE DURING PEDICLE PREP IN COMBINATION WITH SOFT TISSUE PRESSURE AND POOR BONE QUALITY RESULTED IN THE SCREW BEING LATERAL TO THE PLAN. THE SURGEON REDIRECTED THIS SCREW FREEHAND." } ], "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": "" } ] }