{ "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": "3004142400-2025-00252", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251024", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20251002", "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": "UK", "manufacturer_contact_area_code": "610", "date_added": "20251024", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "135099", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20251024", "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-0338", "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", "Human-Device Interface Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251114", "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": "20251024", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Paraplegia", "Paraplegia" ] } ], "distributor_city": "", "date_report": "20251024", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "23383349", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20251006", "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": "383419309", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A PATIENT IS SUFFERING PARAPLEGIA POST EGPS SURGERY. THE SURGEON IMPLIED HE FELT EGPS INSTRUMENTATION MAY HAVE CONTRIBUTED TO THE OUTCOME. SEPARATE CASE SUMMARY SUBMITTED DETAILING OBSERVED SURGICAL EVENTS. FROM INITIAL INFORMATION GATHERING WE HAVE BEEN INFORMED THAT THERE APPEARS TO BE HEMATOMA AND BONE FRAGMENTS IN THE CANAL SPACE AT AROUND THE T9 ANATOMICAL AREA. FROM CONVERSATIONS WITH THE CLINICIAN'S SURGICAL IMPLANTATION FROM THE PROCEDURE APPEARS TO BE CORRECTLY POSITIONED AND IMPLANT ACCURACY APPEARS TO NOT BE IN QUESTION. INITIAL REPORTING FROM THE SURGEON USER APPEARED TO INDICATE HE FELT THAT THE HIGH-SPEED DRILL OR THE PILOT DRILL COULD HAVE MOVED BONE FRAGMENTS INTO THE CANAL AT THIS AREA. IT IS UNCLEAR WHETHER THERE IS ANY EVIDENCE OF INSTRUMENTATION BREACH E.G. CLEARLY DEFINED INSTRUMENT TRACKS, INTO THE CANAL, HOWEVER THE SUGGESTION APPEARED TO BE THE SURGEON FELT THAT THESE INSTRUMENTS MAY HAVE MECHANICALLY DISLODGED THE BONY ANATOMY AND HAD A CAUSATIVE EFFECT." }, { "mdr_text_key": "383419310", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text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} ], "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": "" } ] }