{ "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": "3004142400-2024-00432", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250123", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20230406", "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": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1194607", "implant_date_year": "2023", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20250123", "brand_name": "EXCELSIUS GPSSYSTEM", "generic_name": "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-0382", "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": "20250806", "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": "21220724", "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": "362039186", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "L5-S1 TLIF INTRAOP WITH CREO MIS SCREWS. EVERY STEP WAS DONE EXACTLY LIKE THE PREVIOUS CASES, EXCEPT THAT THE SM WAS NOT ACTIVATED BEFORE THE IMAGING. PATIENT WAS NOT DRAPED DURING O-ARM SCAN, BUT TABLE WAS TRANSLATED INTO THE LUMEN OF THE O-ARM. SNAPSHOT, SCAN AND TRANSFER WERE ALL DONE UNDER APNEA. AFTER THE TRANSFER THE SOFTWARE DID NOT SHOW THE CHECKMARK FOR THE REGISTRATION CONFIRMED, 6 OUT OF 7 FIDUCIALS WERE RECOGNIZED BY THE SYSTEM, ALTHOUGH THE ENTIRE ICT WAS IN THE SCAN. LANDMARK CHECK SEEMED FINE. PLACED FOUR SCREWS (L5L-L5R-S1L AND S1R). POSTOP SCAN REVEALED THAT ALL SCREWS WERE TOO DEEP AND L5-L WAS LATERAL COMPARED TO THE PLANNING. L5-L SCREW WAS REPLACED WITH STEALTH AND THE OTHER SCREWS WERE BACKED OUT A LITTLE. NOTHING SUGGESTED THAT THE SYSTEM CONSIDERED THE PATIENT TO BE POSITIONED LOWER, ALTHOUGH THE EE WAS ALMOST TOUCHING THE SCAN FOR EACH TRAJECTORY ON A MEDIUM SIZED PATIENT. DURING SCREW PLACEMENT, THE ARM COULD NOT BE MOVED AWAY FROM THE TRAJECTORY AFTER DESELECTING THE SCREW AND PRESSING THE FOOT SWITCH. THE ONLY WAY TO MOVE THE ARM AWAY WAS BY USING THE BRACELET." }, { "mdr_text_key": "362039187", "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. FOR THIS CASE, A POST-OPERATIVE SCAN OF THE MISPLACED IMPLANTS WAS PROVIDED. THIS SCAN WAS THEN OVERLAID WITH THE INTRA-OPERATIVE SCAN AND PLANNED SCREWS. THIS OVERLAY SHOWED THAT THE SCREWS ARE PLACED DEEPER THAN THE PLAN; HOWEVER, IT WAS ALSO NOTED THAT THE SCREWS TENDED TO BE LATERAL AND INFERIOR TO THE PLAN. ALL OF THE SCREWS BEING MISPLACED IN THE SAME GENERAL DIRECTION IS SYMPTOMATIC OF A REGISTRATION SHIFT WITH EITHER THE DRB OR THE ICT FOR INTRA-OPERATIVE CASES ULTIMATELY, THE MISPLACED IMPLANTS WERE REVISED INTRA-OPERATIVELY AND THERE WAS NO REPORTED ADVERSE EFFECT TO THE PATIENT. FURTHERMORE, INVESTIGATION OF THE CASE LOGS REVEALED THAT THE SURVEILLANCE MARKER WAS NOT ACTIVATED UNTIL AFTER THE INTRA-OPERATIVE SPIN WAS UPLOADED AND THE 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, IT IS LIKELY THAT THERE WAS A DRB SHIFT AFTER THE INTRA-OPERATIVE SCAN WAS TAKEN BUT BEFORE BEGINNING NAVIGATION. 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": "610", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }