{ "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": "3004142400-2024-00444", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250124", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20230517", "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": "20250124", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "862896", "implant_date_year": "2023", "date_removed_year": "2023", "serviced_by_3rd_party_flag": "U", "date_received": "20250124", "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-0260", "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": "20250124", "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": "20250124", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "21233569", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250122", "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": "362153693", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "RIFAI (DISTRIBUTER REP) INFORMED THAT ONE CASE OF FRACTURE AT T7 WAS PLANNED WITH TWO INTRAOP WORKFLOW. FIRST INTRAOP WAS DONE FROM T5-T9 AND EVERYTHING WAS LOOKING GOOD TILL THE PLACEMENT OF LAST SCREW AT T9-L. SECOND INTRAOP WORKFLOW WAS DONE FROM T11-L3. IT WAS OBSERVED IN THE POST-OP SCAN THAT SCREWS AT T8 & T9 WERE SHIFTED TOWARDS RIGHT SIDE. T8-T9 LEFT SCREWS WERE ALMOST TOUCHING THE CANAL. FINALLY SCREWS AT T8-T9 WERE RE-POSITIONED MANUALLY." }, { "mdr_text_key": "362153694", "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, THE USER REPORTED THAT THE DRB WAS POSITIONED IN THE PATIENT'S PSIS. DUE TO THE DISTANCE OF THE ICT AWAY FROM THE DRB, IT IS BELIEVED THAT THE ICT WAS RESTING ON THE PATIENT'S SKIN SINCE THE ICT PIVOTING ARM IS NOT LIKELY TO REACH FROM THE PSIS TO THE MID/LOWER THORACIC SPINE. FOR THE INTRA-OPERATIVE WORKFLOW, IT IS IMPORTANT THAT THE ICT AND DRB DO NOT MOVE RELATIVE TO PATIENT ANATOMY BETWEEN WHEN THE SURGICAL SNAPSHOT IS CAPTURED AND WHEN THE REGISTRATION IS TRANSFERRED AFTER UPLOADING THE INTRA-OPERATIVE SPIN. IF THE ICT IS SECURED TO THE PATIENT'S SKIN, BREATHING CAN LEAD TO AN ICT SHIFT DURING THE INTRA-OPERATIVE SCAN. A SHIFT OF THE ICT CAN LEAD TO NAVIGATIONAL INTEGRITY ISSUES AND CAN LEAD TO THE MISPLACEMENT OF SCREWS. ULTIMATELY, THE MISPLACED IMPLANTS WERE REVISED INTRA-OPERATIVELY AND THERE WAS NO REPORTED ADVERSE EFFECT TO THE PATIENT. THE SEVERITY IS OBSERVED MATCHES THE ANTICIPATED COMPLAINT SEVERITY. 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": "" } ] }