{ "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": "3004142400-2024-00399", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250123", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20230202", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "19403", "reporter_occupation_code": "NURSE", "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": "20250123", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1586313", "implant_date_year": "2023", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20250123", "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": "HEALTH PROFESSIONAL", "model_number": "6143.1001", "catalog_number": "", "lot_number": "GPS-0378", "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": "20250806", "health_professional": "Y", "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": "20250123", "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": "20250123", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "21218414", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240114", "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": "362038748", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "CASE INFO: DR. (B)(6). L4-S2AI CORTICAL TRAJECTORY OPEN FUSION. 1.1R4 EGPS SOFTWARE. SETUP; DR. (B)(6)' PA, DAMIEN, IMPLANTED THE DRB VIA THE QUATTRO SPIKE INTO THE RIGHT PSIS. (B)(6) THEN IMPLANTED THE SM IN THE LEFT PSIS. EGPS POSITIONED ON THE SAME SIDE AS DAMIEN AND THE C-ARM OPPOSITE THE OR DOOR. CAMERA WAS POSITIONED AT THE FOOT OF THE BED. EXTRA MONITOR FROM SSI USED FOR DR. (B)(6) DURING REGISTRATION THEN FOR (B)(6) FOR SCREW PLACEMENT. (B)(6) THEN VERIFIED SURVEILLANCE. REGISTRATION; THE REGISTRATION TOOK 5 MINUTES. AFTER A SUCCESSFUL MERGE, (B)(6) COMPLETED A LANDMARK CHECK. IMPLANTATION; (B)(6) IMPLANTED EACH SCREW USING; FIRST, THE 4.5 HS DRILL/3.5 TIPPED DRILL, FOLLOWED BY THE SCREW- EVENTUALLY SKIPPING THE 4.5MM HS DRILL. SCREW PLACEMENT FROM L4-S1 TOOK 10 MINUTES. FOR S2AI IT TOOK 30 MINUTES. DR. (B)(6) USED THE TIPPED 5.0/6.0MM CREO MCS DRILL WITH THE 60MM HARD STOP THEN USED A TAP TO GET ACROSS THE JOINT. S2AIL IMPLANTATION WAS SUCCESSFUL BUT S2AIR BREACHED ANTERIORLY. ***WE BELIEVE THAT THE STARTING POSITION FOR S2AIR BEING MORE INFERIOR (PLANNED BELOW 3X SI-BONE SCREWS) THE SI JOINT WAS FURTHER THAN THE HARD STOP PREVENTING THE TIPPED DRILL FROM SUCCESSFULLY CROSSING THE SI-JOINT. THE EE WAS LOWERED USING THE SURGEON BRACELET BUT THE DRILL WAS BOTTOMING OUT AT THE HARD STOP WHICH (B)(6) COULD VISUALIZE. (B)(6) USED THE TAP TO GET ACROSS THE JOINT, HOWEVER THE TAP MUST HAVE WALKED DOWN ALONG THE SI-JOINT - DURING IMPLANTATION WE ONLY RECEIVED DEFLECTION WARNINGS FROM EGPS AFTER THE SCREW HAD PASSED THE SI-JOINT ON NAVIGATION. UPON SCREW PLACEMENT AND CONFIRMATION WITH C-ARM WE NOTICED VIA INLET VIEW THAT THE S2AIR SCREW HAD BREACHED MEDIALLY ABOUT 15MM PARALLEL WITH THE SACRUM THUS NOT REFLECTING (B)(6) SCREW PLAN. (B)(6) IMMEDIATELY REMOVED THE SCREW AND RE-TAPPED THE HOLE BUT THE SAME PATH WAS TAKEN BY THE SAME SCREW AGAIN. (B)(6) WAS WORRIED THE SCREW WAS NOT GOING DOWN THE CORRECT TRAJECTORY. I BELIEVE IT MAY HAVE NOT CROSSED THE SI JOINT DISTALLY. (B)(6) SHORTENED HIS SCREW LENGTH AND IMPLANTED THE SCREW SAFELY. (B)(6) WOULD LIKE A TIPPED DRILL THAT DOESN'T HAVE A HARD STOP IN ORDER TO PREVENT FUTURE OCCURRENCES." }, { "mdr_text_key": "362038749", "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. ENGINEERING EVALUATION DID NOT FIND A SYSTEM MALFUNCTION. INVESTIGATION OF THE CASE LOGS SHOWED NUMEROUS HIGH DEFLECTION WARNINGS DURING SCREW PLACEMENT INDICATING SKIVING. EXCESSIVE FORCE AND SKIVING 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 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": "" } ] }