{ "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": "3004142400-2026-00073", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260414", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20260323", "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": "US", "manufacturer_contact_area_code": "", "date_added": "20260414", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "940406", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20260414", "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-0595", "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": "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" ], "reporter_state_code": "LA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260501", "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": "20260414", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pneumothorax" ] } ], "distributor_city": "", "date_report": "20260414", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "24872119", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260324", "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": "398321806", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THIS WAS A T3-T9 FUSION WITH THE ROBOT USING COMPETITIVE HARDWARE. ONLY NAVIGATED INSTRUMENTS WERE THE HSB, DRILL, TAP, AND AWL. A SPINOUS PROCESS CLAMP WAS PLACED AT T10, AND SM WAS PLACED ON TOP OF THE CLAMP. THE SURGEON WAS INFORMED ABOUT THE CAVEATS OF DOING THIS. AFTER THE HSB AND DRILL WERE USED ON THE FIRST TRAJECTORY ON THE RIGHT T3, THE SURGEON PLACED THE TAP AT THE BEGINNING OF THE PILOT HOLE AND PLACED A K-WIRE DOWN THE TAP WITHOUT THE USE OF ANY IMAGING. THE SURGEON REPORTED THAT K-WIRE FELT LIKE IT WAS \"BOUNCING\" AND NOT IN BONE. HE WAS CONCERNED THAT NAVIGATION WAS INACCURATE AND PLACED THE SCREW USING A PEDICLE FINDER AND C-ARM FOR IMAGING. SHORTLY AFTER MOVING TO THE LEFT, T3 ANESTHESIA REPORTED THE PATIENT'S BLOOD PRESSURE WAS DROPPING. THE SURGICAL TEAM QUICKLY CLOSED THE PATIENT AND FLIPPED TO THE STRETCHER. AFTER FLIPPING ONTO A STRETCHER, ANESTHESIA REPORTED THE PATIENT'S LUNG WAS COLLAPSING AND THAT SHE HAD A POSSIBLE PNEUMOTHORAX. A CHEST TUBE WAS PLACED, AND THE PATIENT WAS STABILIZED TO GET HER TO CT FOR IMAGING." }, { "mdr_text_key": "398321807", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. IT WAS REPORTED THE PROCEDURE FOR LEVELS T3-T9 WAS PERFORMED USING COMPETITIVE HARDWARE, WHERE THERE WAS A REPORTED LOSS OF NAVIGATIONAL INTEGRITY AT T3-R. CASE LOGS WERE NOT SUBMITTED FOR INVESTIGATION, SO NO FORMAL INVESTIGATION COULD BE PERFORMED. HOWEVER, A LOSS OF NAVIGATIONAL INTEGRITY COULD BE ATTRIBUTED TO A DYNAMIC REFERENCE BASE (DRB) . DRB SHIFTS CAN LEAD TO A LOSS OF NAVIGATIONAL INTEGRITY AND MISPLACED IMPLANTS. IF A LOSS OF NAVIGATIONAL INTEGRITY IS SUSPECTED TO HAVE OCCURRED, IT IS RECOMMENDED TO PERFORM A LANDMARK CHECK OR VERIFICATION TO ENSURE THE REGISTRATION WAS SUCCESSFULLY CALCULATED. ULTIMATELY, THE USER OPTED TO ABORT THE CASE AFTER T3-R WAS PLACED, WITH A POTENTIAL PNEUMOTHORAX REPORTED AS EFFECT TO THE PATIENT. THE PATIENT WAS STABILIZED AND NO FURTHER EFFECTS TO THE PATIENT WERE REPORTED. 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." } ], "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": "" } ] }