{ "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": "2026-10-07", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "N", "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": "+1(610)9", "event_type": "Injury", "report_number": "3004142400-2026-00118", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260610", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20260514", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "19403", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "+1(610)930-1800", "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": "20260610", "manufacturer_contact_f_name": "Daniel", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "149996", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260610", "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-0605", "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": "", "udi_public": "", "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": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/11/2026", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260922", "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": "20260610", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "50 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20260818", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "Audubon", "mdr_report_key": "25459392", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260514", "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": "404055149", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE WAS UNAVAILABLE FOR EVALUATION. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE." }, { "mdr_text_key": "404055150", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING AN EXCELSIUS GPS SURGERY THE DRB WAS BUMPED/SHIFTED DURING CASE. THE PATIENT WAS ON THE HEAVIER SIDE; THERE WAS LOT OF TISSUE PUSHING. THE FIRST SCREW ENDED UP BEING A MISS. WE ENDED UP BRINGING IN THE C-ARM TO RETAKE SHOTS. FIRST SCREW WAS NOT PLACED WITH DURA-PRO AS WE COULD NOT GET IT TO VERIFY THIS MORNING. HIGH SPEED BURR, TAP THAN SCREW WAS USED. AFTER THE RE-MERGE WE FINALLY GOT DURAPRO TO VERIFY SO WE PLACED L5 RIGHT AN L4 LEFT NORMALLY. THE DOCTOR PLACED L5 LEFT, BUT HE DID NOT LIKE THE SCREW PLACEMENT SO HE ABORTED THE ROBOT. THE SURGEON ENDED UP REPOSITIONING THE SCREW, PLACING IT BY HAND. HE DID THE REST OF THE CASE WITHOUT NAVIGATION." } ], "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": "08/18/2026" } ] }