{ "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": "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": "3004142400-2026-00165", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260716", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20260317", "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": "20260716", "manufacturer_contact_f_name": "Daniel", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "702175", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260716", "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-0295", "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" ], "reporter_state_code": "IN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/30/2026", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260806", "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": "20260716", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20260806", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "Audubon", "mdr_report_key": "25846856", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260317", "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": "407767896", "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": "407767897", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING AN EXCELSIUSGPS SURGERY THE SURGEON BELIEVED THAT THE EGPS NAVIGATION WAS OFF TRAJECTORY. BOTH THE DOCKING WITH THE RETRACTOR AND IMPLANT PLACEMENT RESULTING IN ANTERIOR PLACEMENT, ALTHOUGH PLANNING AND REAL TIME NAVIGATION WERE DISPLAYING MIDLINE PLACEMENT. THE SURGEON HAD TO CLOSE RETRACTOR, RE-MERGE, AND ADJUST PLACEMENT OF THE RISE-L CAGE. HE WAS UNEASY ABOUT THE DANGERS OF GOING TOO ANTERIOR AT THE L2-4 LEVELS WITH THE GREAT VESSELS BEING THERE AND THE POSSIBILITY OF PUNCTURING/RUPTURING THE ALL. THE IMPLANT WAS REMOVED AND REDIRECTED. THE NAV IMAGING SHOWED THE SURGEON WAS PLACING THE IMPLANT MIDLINE BETWEEN THE TWO VERTEBRA AS PRE PLANNED. THE XR AFTER PLACEMENT SHOWED THE IMPLANT SIGNIFICANTLY MORE ANTERIOR. THE ALL DID NOT SEEM TO BE COMPROMISED, BUT WE REMERGED AND USED THE SAME IMPLANT TO COLLAPSE AND REDIRECT. ULTIMATELY, SURGERY WAS COMPLETED WITH NO PATIENT COMPLICATIONS." } ], "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": "08/06/2026" } ] }