{ "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": "3004142400-2024-00435", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250123", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20230424", "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": "20250123", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1586329", "implant_date_year": "2023", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20250123", "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": "", "model_number": "6143.1001", "catalog_number": "", "lot_number": "GPS-0393", "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": "20250801", "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": "20250123", "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": "20250123", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "21218710", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240115", "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": "361963097", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "3 MISSED SCREWS IN THIS CASE. ALL SIGNS ARE INDICATIVE OF ICT SHIFTING, BUT LANDMARK CHECKS DID NOT SHOW THAT. WE HAD ONLY A SURVEILLANCE METER SHOWING (LIKE WE ARE IN FREE HAND NAV MODE) AND NO DEFLECTION FORCE METER SHOWING. WE WERE GETTING HIGH DEFLECTION WANING ON THE SCREEN. IT SEEMED LIKE THIS WAS NORMAL DUE TO SCREW TORQUE FORCE. THE L5-R SCREW ON THE SCREEN SHOWED IT WAS PLACED TO PLAN WITH NO ISSUES. POST OP SHOTS SHOWED IT LATERAL OF THE PEDICLE. THE S1 SCREWS BOTH WERE PLACED ON THE RIGHT TRAJECTORY THAT WE HAD, BUT WERE EXTREMELY DEEP. WE STRUGGLED GREATLY AT L5-L AND DID NOT END UP PLACING THAT SCREW WITH THE ROBOT. WE BAILED TO FLUORO FOR FREE HAND SCREWS." }, { "mdr_text_key": "361963098", "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 CASE LOGS SHOWED THAT THE SURVEILLANCE MARKER WAS ACTIVATED AND THEN DEACTIVATED BEFORE THE INTRA-OPERATIVE SCAN WAS UPLOADED; THEREFORE, THE SOFTWARE IS UNABLE TO DETECT AND ALERT THE USER OF ANY POTENTIAL DRB SHIFTS UNTIL THE SURVEILLANCE MARKER IS REACTIVATED. BEFORE PROCEEDING WITH NAVIGATION, THE USER ACKNOWLEDGES THAT THEY WILL PERFORM AN ANATOMICAL LANDMARK CHECK TO ENSURE NAVIGATIONAL INTEGRITY. INVESTIGATION OF THE CASE LOGS REVEALED THAT THE SURVEILLANCE MARKER WAS ACTIVATED AND PAIRED TO THE DRB BEFORE THE INTRA-OPERATIVE SPIN WAS TAKEN; HOWEVER, THIS PAIRING WAS CANCELED SHORTLY AFTER AND WAS NOT REPAIRED UNTIL AFTER THE INTRA-OPERATIVE SCAN WAS UPLOADED TO THE SYSTEM AND REGISTRATION WAS TRANSFERRED. IF THE SURVEILLANCE MARKER WAS NOT ACTIVATED DURING THE INTRA-OPERATIVE SPIN, THIS MEANS THAT THE SOFTWARE WOULD NOT BE ABLE TO DETECT OR ALERT THE USER OF A POTENTIAL DRB SHIFT. DURING THIS TIME, IT'S IMPORTANT TO HAVE THE SURVEILLANCE MARKER ACTIVATED TO BE ABLE TO DETECT IF THE DRB WAS ACCIDENTALLY MOVED DURING DRAPING, UNDRAPING OR ICT REMOVAL. DUE TO THIS, A DRB SHIFT CANNOT BE ENTIRELY RULED OUT AS A POTENTIAL ROOT CAUSE FOR THE MISPLACEMENT OF SCREWS. ULTIMATELY, THE MISPLACED IMPLANTS WERE REVISED INTRA-OPERATIVELY AND THERE WAS NO REPORTED ADVERSE EFFECT TO THE PATIENT. THE OBSERVED OVERALL RISK LEVEL IS 18, OR 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": "610", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }