{ "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": "3004142400-2026-00033", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260302", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20260130", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "19403", "reporter_occupation_code": "PHYSICIAN", "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": "", "date_added": "20260302", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "538941", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20260302", "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-0156", "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": "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": "NJ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260327", "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": "20260302", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "38 YR", "patient_sex": "Male", "patient_weight": "75 KG", "patient_ethnicity": "", "patient_race": "Black Or African American", "patient_problems": [ "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20260302", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "24485168", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260203", "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": "394437551", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. NO CASE LOGS WERE SUBMITTED, SO NO FORMAL INVESTIGATION COULD BE PERFORMED. HOWEVER, IT WAS REPORTED BY A GLOBUS MEDICAL REPRESENTATIVE THAT DURING THE PRE-OPERATIVE CT WORKFLOW, ONE IMPLANT WAS MISPLACED INFERIORLY AND POSTERIORLY. ONE IMPLANT HAVING NAVIGATIONAL INTEGRITY ISSUES CAN BE INDICATIVE OF EXCESSIVE DEFLECTION FORCES, OR SKIVING. SKIVING CAN LEAD TO THE MISPLACEMENT OF IMPLANTS. ULTIMATELY, THE USER OPTED TO RE-REGISTER THE PATIENT WITH NEW FLUOROSCOPIC IMAGES AND REPLACED THE MISPLACED IMPLANT WITH NO ADVERSE EFFECT TO THE PATIENT REPORTED. THIS EVALUATION HAS BEEN COMPLETED WITHOUT ASSOCIATED CASE LOGS AND THERE ARE NO ASSOCIATED WORK ORDER OR PART RETURNS. THE SEVERITY OBSERVED DID NOT EXCEED THE ANTICIPATED 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." }, { "mdr_text_key": "394437552", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT WHEN DOING AN SI JOINT FUSION WITH OUR SURGEON, OUR MERGE SEEMED TO BE GOOD. HOWEVER, UPON STARTING THE FIRST SCREW, THE HIGHSPEED DRILL WAS NOTICEABLY DEEPER THAN ITS ACTUAL DEPTH. WE TRIED TO FIX IT AND WHEN STANDARD TROUBLE SHOOTING WAS DONE NOTHING CHANGED BUT THE SURGEON WANTED TO PROCEED. THE SCREW PLACED WAS POSTERIOR AND INFERIOR TO THE PLAN. WE DECIDED TO COMPLETELY REMERGE. SIMILAR SHOTS WERE TAKEN AND THE SCREWS WERE PLACED TO PLAN WITH NO DEPTH ISSUES." } ], "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": "" } ] }