{ "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": "3004142400-2024-00477", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20250127", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20230807", "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": "20250130", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "633576", "implant_date_year": "2023", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20250127", "brand_name": "EXCELSIUS GPS", "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-0405", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "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": "01/24/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250825", "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": "20250127", "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": "20250129", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "21243195", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250124", "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": "363332870", "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. THE USER THEN PERFORMED A NAVIGATIONAL LANDMARK CHECK, REPAIRED SURVEILLANCE, AND PROCEEDED WITH NAVIGATION. THE USER REPORTED THAT DESPITE THIS, THE IMPLANT WAS PLACED LATERALLY TO PLAN AND OPTED TO REPLACE IT BY CREATING A NEW CASE. DURING THE BONE PREP WORK FOR THE REPLACEMENT OF THE IMPLANT, THE SOFTWARE DETECTED AND ALERTED THE USER OF EXCESSIVE DEFLECTION FORCES ON THE LOAD CELL. 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 FORCE AND ALERTED THE USER OF IT. THE USER REPORTED NO ADVERSE THE SEVERITY IS 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4, D2, G6, H10." }, { "mdr_text_key": "363332871", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "PROCEDURE WAS A L2-L4 LUMBAR FUSION. BEGINNING OF THE CASE WAS NORMAL: INTRAOP WORKFLOW WITH E3D. DRB WAS PLACED IN THE R PSIS, AND SURVEILLANCE MARKER PLACED IN L PSIS (SUCCESSFULLY ACTIVATED). SET UP, IMAGING, AND PLANNING OF THE SCREWS ALL COMPLETED WITHOUT ANY ISSUES. HOWEVER, WHEN MOVING THE ROBOT WITHIN NAVIGATION RANGE, SURGICAL TEAM MOVED EE VIA BRACELET INTO THE DRB, CAUSING IT TO VISIBLY SHIFT. HOWEVER, UPON REPOSITIONING OF THE ARM, DRB APPEARED TO MOVE BACK INTO ORIGINAL LOCATION. THE POST IN THE PSIS WAS CHECKED, AND APPEARED STABLE. FOLLOWING THIS, LANDMARK CHECKS WERE COMPLETED AND IT WAS DECIDED THAT ANATOMY/NAVIGATIONAL INTEGRITY APPEARED ACCURATE. FOLLOWING PLACEMENT OF ALL 6 SCREWS, 1 SCREW (R L2) WAS FAR TOO LATERAL, AND THE DECISION WAS MADE TO REMOVE THE SCREW AND NAVIGATE A NEW SCREW. A SECOND CASE WAS MADE, AND THE POST-OPERATIVE E3D SPIN WAS USED FOR A PRE-OP PROTOCOL. MERGE WAS SUCCESSFUL, HOWEVER THE SCREW PLACEMENT WAS AGAIN LATERAL. WE ARE CERTAIN THERE WAS A DRB SHIFT DURING THE FIRST PORTION OF THE CASE, CAUSING THE SCREWS TO APPEAR LATERAL. HOWEVER WE ARE UNSURE AS TO WHY THE REPLACEMENT SCREW WAS ALSO LATERAL. OUR THOUGHT IS THAT IT MAY HAVE SLID INTO THE TRACK OF THE FIRST SCREW, HOWEVER WE ARE HOPING TO GAIN CLARITY FOR THIS PORTION OF THE CASE." }, { "mdr_text_key": "362479759", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "PROCEDURE WAS A L2-L4 LUMBAR FUSION. BEGINNING OF THE CASE WAS NORMAL: INTRAOP WORKFLOW WITH E3D. DRB WAS PLACED IN THE R PSIS, AND SURVEILLANCE MARKER PLACED IN L PSIS (SUCCESSFULLY ACTIVATED). SET UP, IMAGING, AND PLANNING OF THE SCREWS ALL COMPLETED WITHOUT ANY ISSUES. HOWEVER, WHEN MOVING THE ROBOT WITHIN NAVIGATION RANGE, SURGICAL TEAM MOVED EE VIA BRACELET INTO THE DRB, CAUSING IT TO VISIBLY SHIFT. HOWEVER, UPON REPOSITIONING OF THE ARM, DRB APPEARED TO MOVE BACK INTO ORIGINAL LOCATION. THE POST IN THE PSIS WAS CHECKED AND APPEARED STABLE. FOLLOWING THIS, LANDMARK CHECKS WERE COMPLETED AND IT WAS DECIDED THAT ANATOMY/NAVIGATIONAL INTEGRITY APPEARED ACCURATE. FOLLOWING PLACEMENT OF ALL 6 SCREWS, 1 SCREW (R L2) WAS FAR TOO LATERAL, AND THE DECISION WAS MADE TO REMOVE THE SCREW AND NAVIGATE A NEW SCREW. A SECOND CASE WAS MADE, AND THE POST-OPERATIVE E3D SPIN WAS USED FOR A PRE-OP PROTOCOL. MERGE WAS SUCCESSFUL; HOWEVER, THE SCREW PLACEMENT WAS AGAIN LATERAL. WE ARE CERTAIN THERE WAS A DRB SHIFT DURING THE FIRST PORTION OF THE CASE, CAUSING THE SCREWS TO APPEAR LATERAL. HOWEVER, WE ARE UNSURE AS TO WHY THE REPLACEMENT SCREW WAS ALSO LATERAL. OUR THOUGHT IS THAT IT MAY HAVE SLID INTO THE TRACK OF THE FIRST SCREW, HOWEVER WE ARE HOPING TO GAIN CLARITY FOR THIS PORTION OF THE CASE." }, { "mdr_text_key": "362479760", "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. THE USER THEN PERFORMED A NAVIGATIONAL LANDMARK CHECK, REPAIRED SURVEILLANCE, AND PROCEEDED WITH NAVIGATION. THE USER REPORTED THAT DESPITE THIS, THE IMPLANT WAS PLACED LATERALLY TO PLAN AND OPTED TO REPLACE IT BY CREATING A NEW CASE. DURING THE BONE PREP WORK FOR THE REPLACEMENT OF THE IMPLANT, THE SOFTWARE DETECTED AND ALERTED THE USER OF EXCESSIVE DEFLECTION FORCES ON THE LOAD CELL. 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 FORCE AND ALERTED THE USER OF IT. THE USER REPORTED NO ADVERSE THE SEVERITY IS 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." } ], "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": "01/29/2025" } ] }