{ "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": "3004142400-2023-00088", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240305", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20230511", "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": "20240305", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "138848", "implant_date_year": "2023", "date_removed_year": "2023", "serviced_by_3rd_party_flag": "U", "date_received": "20240305", "brand_name": "EXCELSIUS", "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": "HEALTH PROFESSIONAL", "model_number": "6143.1001", "catalog_number": "", "lot_number": "GPS-0188", "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": "", "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", "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": "20250728", "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": "20240305", "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": "20240209", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "18834294", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20230519", "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": "336852530", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THERE WAS NO SYSTEM MALFUNCTION. INVESTIGATION OF THE CASE LOGS REVEALED THAT THE ROOT CAUSE IS TRACED TO USER TECHNIQUE. FOR THE FIRST PORTION OF THE CASE, THE USER REPORTED THAT T9-T12 WAS MISPLACED BILATERALLY. WHEN COMPARING THE PLACEMENT OF SCREWS WITH THE INTENDED PLAN, IT WAS NOTED THAT ALL OF THE SCREWS WERE MISPLACED IN THE SAME DIRECTION, WHICH IS SYMPTOMATIC OF A DRB SHIFT OR AN ICT SHIFT. THE LOGS SHOWED THAT THE SURVEILLANCE MARKER WAS NOT ACTIVATED UNTIL AFTER THE INTRA-OPERATIVE SCAN WAS UPLOADED AND THE REGISTRATION WAS TRANSFERRED FROM THE ICT TO THE DRB. THIS MEANS THAT THE DRB LIKELY MOVED RELATIVE TO THE PATIENT, AS THE SOFTWARE DID NOT DETECT A POTENTIAL ICT SHIFT. IF THE SURVEILLANCE MARKER IS NOT ACTIVATED, THE SOFTWARE IS UNABLE TO DETECT AND ALERT THE USER OF POTENTIAL DRB SHIFTS. BEFORE PROCEEDING WITH NAVIGATION, THE USER ACKNOWLEDGES THAT THEY WILL PERFORM AN ANATOMICAL LANDMARK CHECK TO ENSURE NAVIGATIONAL INTEGRITY. NEXT THE USER RE-REGISTERED THE PATIENT AND NAVIGATED L2-L5 TO EXTEND THE CONSTRUCT. DURING THIS REGISTRATION IT WAS REPORTED THAT THE L2-R AND L4-R SCREWS WERE MISPLACED. INVESTIGATION OF THE CASE LOGS REVEALED THAT FOR THIS REGISTRATION, THE SURVEILLANCE MARKER WAS NOT ACTIVATED UNTIL AFTER THE INTRA-OPERATIVE SCAN WAS UPLOADED AND THE REGISTRATION WAS TRANSFERRED FROM THE ICT TO THE DRB; THEREFORE, THE SOFTWARE IS UNABLE TO DETECT AND ALERT THE USER OF A POTENTIAL DRB SHIFT. FURTHERMORE, DURING NAVIGATION THE SOFTWARE DETECTED EXCESSIVE FORCES ON THE LOAD CELL DURING BONE WORK. THIS IS THE RESULT OF SKIVING FORCES DETECTED WHILE A TOOL IS INSERTED INTO THE END EFFECTOR. SKIVING CAN LEAD TO THE MISPLACEMENT OF SCREWS. THE SOFTWARE CORRECTLY DETECTED THE FORCES AND ALERTED THE USER. THE CAUSE OF THE REPORTED ISSUE WAS TRACED TO USER TECHNIQUE." }, { "mdr_text_key": "336852531", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM." } ], "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": "" } ] }