{ "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": "3004142400-2024-00335", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250129", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20220630", "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": "20250129", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "499539", "implant_date_year": "2022", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20250129", "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-0330", "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": "20250825", "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": "20250129", "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": "20250129", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "21264894", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250128", "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": "362424124", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "C3-T4 OPEN POSTERIOR CERVICO-THORACIC FUSION. 1.1R4 SOFTWARE. PRE-OP CT WORKFLOW. 12\" FLUOROSCOPY. CT-SCAN LOADED AND SCREWS PREPLANNED. HE ONLY PLANNED TO USE EGPS TO PUT IN SCREWS AT T2-T4. PRIOR TO THE SURGERY, THE PATIENT HAD A FRACTURE AT C7-T1 CAUSING THE PREVIOUS POSTERIOR SCREWS TO PULL OUT AT T1-T2. DR. (B)(6) PUT THE ANGLED SPINOUS PROCESS CLAMP ON T5 AND DUE TO THE AMOUNT OF SKIN THE ANGLED SPINOUS PROCESS CLAMP WAS POINTING STRAIGHT UP. THUS NOT ALLOWING THE C-ARM INTO TO POSITION FOR REGISTRATION IMAGED. FOLLOWING THAT MISTAKE HE PUT A SHORTER SPINOUS PROCESS CLAMP ON THE SP. SM WAS ON THE SAME CLAMP. THIS ALLOWED THE C-ARM TO MOVE UNDER THE BED WITHOUT HITTING THE MAYFIELD ATTACHMENT HOWEVER, THE LATERAL SHOT WAS DIFFICULT TO VISUALIZE ON THE C-ARM. DR. (B)(6) HAD A DIFFICULT TIME IDENTIFYING EACH LEVEL DUE TO THE MINIMAL CONTRAST OF THE C-ARM. THE SETTING WERE ADJUSTED TO BETTER THE IMAGE ON THE C-ARM BUT THE MERGE WAS UNSUCCESSFUL. THE MERGE LOOKED LIKE IT HAD FOUND THE AN IMAGE ON THE CT THAT WAS IN AN OBLIQUE AP VIEW. FOR THE LATERAL, IT COULD NOT IDENTIFY THE CORRECT LEVEL. WE RESET THE SOFTWARE, FOLLOWED BY COMPLETE REBOOT BUT IT CONTINUED TO FAIL THE MERGE. SCORES RANGED FROM 2,3, AND 4. CENTROIDS WERE ADJUSTED AND THE MERGE CONTINUED TO FAIL. THE PATIENT HAD A LOT OF CORRECTION ON THE TABLE MAKING THE MERGE MORE DIFFICULT. AFTER 2 FAILED ATTEMPTS AT RESTARTING REGISTRATION FROM THE BEGINNING DR. (B)(6) ASKED FOR THE ZHEIM 3D SCANNER. IT HOWEVER, WOULD NOT FIT IN POSITION UNDER PATIENT WITH THE MAYFIELD ATTACHMENT IN PLACE. NOR COULD THE TECH GET THE ZHEIM TO A LATERAL BECAUSE OF THE HEIGHT OF THE ICT PREVENTED THE MACHINE FROM PASSING OVER. THE ICT, DRB AND SURVEILLANCE WERE ALL TOO HIGH DUE TO THE KYPHOSIS OF THE SPINE AND THE FAT LAYER PREVENTING BEFORE MENTIONED TO BE CLOSER TO THE SPINE. DR. (B)(6) ABORTED EGPS ASSISTANCE AND COMPLETED THE CASE FREEHAND." }, { "mdr_text_key": "362424125", "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 PURPOSE OF THIS INVESTIGATION IS TO EVALUATE THE RISK ASSOCIATED WITH THE IDENTIFIED FAILURE MODE OF \"PRE-OP CT TO 2D REGISTRATION FAILS\" FOR EGPS 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 POOR SCAN QUALITY, ALONG WITH A LACK OF CONTRAST AND BRIGHTNESS IN FLUOROSCOPIC SHOTS RESULTED IN A DIFFICULT MERGE. SUGGESTED TROUBLESHOOTING MEASURES FOR THE USER WOULD BE TO ENSURE THERE ARE NO TRACKING ERRORS, TRY DIFFERENT SHOTS AND REGISTRATION TYPES, TAKE MORE TRUE 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." } ], "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": "" } ] }