{ "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": "3004142400-2024-00418", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250124", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20230323", "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": "862257", "implant_date_year": "2023", "date_removed_year": "", "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-0290", "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": "", "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": "20250123", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "21233517", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240115", "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": "362155414", "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. INVESTIGATION OF THE CASE LOGS SHOWED THAT THE ROOT CAUSE IS TRACED TO USER TECHNIQUE. REVIEW OF THE PREOPERATIVE PLAN REVEALED THAT THE TRAJECTORY IS PLANNED IN A HIGH-SKIVE AREA. THE USER CAN VISUALIZE THE PREOPERATIVE PLAN OVERLAID ON PATIENT ANATOMY BEFORE PROCEEDING WITH NAVIGATION. ADDITIONALLY, DURING NAVIGATION OF THE SOFTWARE DETECTED EXCESSIVE FORCES ON THE LOAD CELL DURING BONE WORK. 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. ULTIMATELY, THE SCREW IN THIS CASE WAS REVISED INTRA- OPERATIVELY AND THERE WAS NO REPORTED ADVERSE EFFECT TO THE PATIENT. 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." }, { "mdr_text_key": "362155415", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "CASE WAS PERFORMED AS AN OPEN, FOR L2-S2 CONSTRUCT. DUE TO THE INABILITY TO GET THE BOTTOM HALF OF THE PELVIS IN ONE INTRA-OP SPIN USING O-ARM, CASE WAS EXECUTED USING 2 SPINS/CASES/MERGES, BUT SAME DRB/SURVEILLANCE MARKER PLACEMENT FOR EACH CASE. PATIENT WAS POSITIONED PRONE THROUGHOUT THE ENTIRETY OF THE CASE. DRB WAS PLACED IN PATIENT RIDE SIDE PSIS AND SURVEILLANCE MARKER WAS PLACED IN PATIENT'S LEFT SIDE PSIS. WE PROCEEDED WITH OUR TWO PINS FOR OUR PREOP WORKFLOW. SCREWS WERE PLANNED FOR OUR FIRST CASE AS L2-S1 AND WERE CHECKED/CONFIRMED BY DR. (B)(6). SCREWS WERE PLANNED FOR OUR SECOND CASE AS L5-S2 AND WERE CHECKED/CONFIRMED BY DR. (B)(6), AGAIN. WE INITIALLY MERGED OUR FIRST CASE AND EXECUTED PUTTING SCREWS IN AT LEVELS L2-S1. THESE SCREWS ALL WENT IN GREAT AND LOOKED SPOT ON OUR FINAL X-RAYS. WE THEN PROCEEDED WITH OUR SECOND CASE MERGING LEVELS L5-S2. THIS CASE WAS ONLY USED TO PUT IN S2AI SCREWS. WE WERE ABLE TO GET A SUCCESSFUL MERGE AND THEN PROCEEDED WITH PUTTING IN S2AI SCREWS. DR. (B)(6) WAS WORKING FROM PATIENT'S RIGHT SIDE, SO WAS ABLE TO PUT PATIENT'S LEFT SIDED SCREW IN UTILIZING HIGH SPEED BURR, MCS DRILL, TAP, SCREW ON POWER TECHNIQUE WITH EASE. WE THEN PROCEEDED TO THE RIGHT SIDE MEANWHILE DR. (B)(6) WAS WORKING FROM THE PATIENT'S LEFT SIDE, GIVING HIM THE ADVANTAGE IN PUTTING IN THE PATIENT'S RIGHT SIDE S2AI SCREW FROM THIS POSITION. DR. (B)(6) UTILIZED THE SAME STEPS IN GOING HIGH SPEED BURR, MCS DRILL, TAP, SCREW ON POWER. DURING THESE STEPS IT WAS NOTICED THAT DR. (B)(6) MIGHT HAVE JUST CROSSED THE JOINT BUT MAY NOT HAVE BROKEN THROUGH THE FAR/NEAR CORTEX. IT WAS THEN QUESTIONED AT THIS POINT TO DR. (B)(6) WHETHER HE HAD BROKEN THROUGH THE FAR/NEAR CORTEX? HE REPLIED THAT IT WAS JUST THROUGH THE CORTEX. DURING DR. (B)(6)'S SCREW PLACEMENT, WE NOTICED THE DEFLECTION METER WAS GOING UP, BUT AT THE TIME DIDN'T HAVE A CONCRETE EXPLANATION AS TO WHY?.. UPON COMPLETION OF PUTTING IN SCREWS, WE TOOK FLURO IMAGES. IT APPEARED THE RIGHT SIDED SCREW MIGHT HAVE TRAVELED DOWN THE JOINT, BUT OUR LEFT SIDED SCREW WAS TO PLAN. I RECOMMENDED WE GO BACK AND LOOK AT THE PLAN TO MAKE SURE NOTHING HAD CHANGED/MAKE ANY ADJUSTMENTS NEEDED. THE PLAN WAS CONFIRMED BY BOTH DOCS AS \"GOOD.\" MY RECOMMENDATION WAS TO REDO ALL OUR INITIAL STEPS, BUT ALSO BE SURE TO TRAVEL INTO THE FAR CORTEX A BIT MORE THIS TIME AROUND WITH OUR DRILL/TAP. DR. BOONE AGREED TO THIS PROCESS, BUT ONCE HE STARTED DIGGING AROUND WITH HIS PROBE, HE QUESTIONED THE INITIAL TRAJECTORY WHICH AT THIS POINT WE RECOMMENDED HIM TO USE THE VERIFICATION PROBE TO PLAN HIS SCREW TRAJECTORY. HE OBLIGED TO THE RECOMMENDATION. EVEN THOUGH WE HAD A NEW TRAJECTORY PLAN, DR. (B)(6) ENDED UP PUTTING IN THE SCREW MANUALLY." } ], "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": "" } ] }