{ "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": "3004142400-2026-00026", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260226", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20260127", "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": "20260226", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "516355", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20260226", "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-0484", "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": "VA", "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": "20260226", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20260226", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "24454517", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260127", "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": "394038066", "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 THE SURVEILLANCE METER INDICATED A POTENTIAL DYNAMIC REFERENCE BASE (DRB) SHIFT DURING NAVIGATION, LEADING TO A MISPLACED IMPLANT. DURING THE PRE-OPERATIVE REGISTRATION AND AFTER THE REGISTRATION HAS BEEN COMPLETED, USERS SHOULD PERFORM A LANDMARK CHECK OR VERIFICATION TO ENSURE THE REGISTRATION HAS BEEN SUCCESSFULLY CALCULATED. IT IS ALSO ADVISABLE TO MONITOR THE PATIENT MOVEMENT BAR, AS THIS TRACKS MOVEMENT OF THE DRB WITH RESPECT TO THE FLUOROSCOPY REGISTRATION FIXTURE. WHEN NAVIGATING ON THE NAVIGATE TAB, MAKE SURE TO MONITOR THE SURVEILLANCE MARKER DURING THE PROCEDURE, AND IF THE SURVEILLANCE MARKER INDICATES SIGNIFICANT MOVEMENT OF THE DRB, THEN PERFORM AN ANATOMICAL LANDMARK CHECK. IF THE LANDMARK CHECK IS SATISFACTORY, RE-REGISTER THE SURVEILLANCE MARKER, BUT IF THE LANDMARK CHECK FAILS, RE-REGISTER THE PATIENT. ULTIMATELY, THE USER OPTED TO REPLACE THE MISPLACED IMPLANT USING TRADITIONAL METHODS WITH NO ADVERSE EFFECT TO THE PATIENT REPORTED. 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": "394038069", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE SURVEILLANCE HAS BEEN UNABLE TO HOLD GREEN STATUS AND DRIFTS TO YELLOW AND RED CONSTANTLY FOR THE LAST SEVERAL WEEKS. TODAY ANOTHER SCREW WAS PLACED LATERAL TO THE PEDAL SIMILAR TO WHAT HAPPENED TWO WEEKS AGO ON THE SAME UNIT EXHIBITING THE SAME PROBLEMS. THIS HAPPENED ONE OTHER TIME A FEW WEEKS EARLIER. THE SURGEON REMOVED THE BREACHED SCREW AND REPLACED USING TRADITIONAL NON-ROBOTIC/NAVIGATED MANNER. THE SURGEON HAS PUT OVER A THOUSAND SCREWS IN WITH THE ROBOT AND THIS IS THE SECOND TIME THIS HAS HAPPENED IN THE LAST TWO WEEKS WITH THE SAME UNIT EXHIBITING THE SAME ISSUE." } ], "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": "" } ] }