{ "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": "3004142400-2024-00406", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250124", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20230218", "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": "2550444", "implant_date_year": "2023", "date_removed_year": "2023", "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": "HEALTH PROFESSIONAL", "model_number": "6143.1001", "catalog_number": "", "lot_number": "GPS-0309", "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": "20250124", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "21233163", "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": "362159847", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "CASE FLOW: PATIENT WAS PREPPED AND POSITIONED PER STANDARD MEANS AND SCOUT SHOTS OF LUMBAR ANATOMY WAS TAKEN VIA X-RAY AND VERTEBRAL MARKS PLACED ON SKIN. DR. (B)(6) THEN EXPOSED L1 AND L2 PLACING THE SPINOUS PROCESS CLAMPS FOR THE DRB (ON L2) AND ICT/ SURVEILLANCE MARKER (SM) (ON L1). SM WAS REGISTERED AND THE O-ARM BROUGHT INTO POSITION AT TABLE. P/A, LAT, AND A/P SCOUT SHOTS WERE TAKEN TO ENSURE CORRECT LEVELS AND ICT FRAME FIDUCIALS WERE VISUALIZED FOR THE SPIN. SOME ADJUSTMENTS TO THE ICT FRAME AND PIVOT ARM WERE MADE TO ENSURE THAT EVERYTHING WAS ALIGNED. AT THIS TIME THE FIELD CAPTURE SNAPSHOT WAS TAKEN, THE ICT/DRB WERE COVERED WITH BLUE STERILE CLOTH, RESPIRATIONS HELD AND A CT SPIN WAS TAKEN. THE SCAN WAS CHECKED TO ENSURE THE ICT AND FIDUCIALS WERE ALL CAPTURED. THE SCAN WAS EXPORTED VIA USB THUMB DRIVE AND TRANSFERRED SUCCESSFULLY TO THE EXCELSIUS GPS WHERE THE REGISTRATION FIT WAS VERY GOOD. THE O-ARM WAS REMOVED FROM THE TABLE, BLUE CLOTH REMOVED, ICT PIVOT ARM REMOVED FROM CLAMP, SM REMOVED TO SLIDE OFF ICT CLAMP AND REPLACED. SKIN LANDMARK CHECKS WERE DONE AND SM WAS RE-REGISTERED. SINCE L1 SPINOUS PROCESS WAS VISIBLE IN THE SCAN AND DIRECT ACCESS WAS POSSIBLE VIA THE INCISION, THE LANDMARK PROBE WAS PLACED ON THIS AND SWEPT THE SIDES WHICH APPEARED TO BE ACCURATE. DR. (B)(6) FOLLOWING AGREED UPON BEST PRACTICE INSTRUCTIONS TO MAINTAIN HIGHEST PREDICTABILITY OF ACCURACY WHEN A FRACTURE IS PRESENT, NAVIGATED FIRST TO T11 RIGHT PEDICLE. INSTRUMENT FLOW TO PREPARE THE PEDICLE AND PLACE SCREW WAS DONE WITH EXCELLENT TECHNIQUE USING VERY LIGHT DOWNWARD PRESSURE OF HSD AND DRILL, FOLLOWED BY FEELER PROBE ENSURE THE HOLE WAS ACCEPTABLE. THE SCREW WAS THEN PLACED VIA DRIVER ON T-HANDLE AND STEPS WERE REPEATED TO THE LEFT T11 TRAJECTORY. DR. (B)(6) THEN NAVIGATED TO T10 TRAJECTORIES. THE SAME INSTRUMENT TECHNIQUES WERE USED. TO ENSURE THAT THE NAVIGATION ACCURACY OF LOCATION AND DEPTH WAS INTACT, DR. (B)(6) TOUCHED TOP OF EACH SCREW HEAD WITH THE LANDMARK PROBE SHOWING GOOD ALIGNMENT. THE TRAJECTORIES OF T12 DOWN TO L1 WERE THEN PLACED FOLLOWING SERPENTINE PATTERN WORKING FROM DISTAL TO PROXIMAL TOWARDS THE DRB. AT NO POINT WERE THERE SIGNS OR WARNINGS NOTED THAT INDICATED EXCESSIVE FORCE/DEFLECTION OF INSTRUMENT THROUGH END EFFECTOR. NO WARNINGS WERE DISPLAYED FOR SM REGARDING CONCERN WITH DISTANCE TRACKED WITH THE DRB POSITION. FOLLOWING THE PLACEMENT OF BOTH RODS, DR. (B)(6) ORDERED FLAT PANEL X-RAYS TO BE DONE FOR A/P AND LAT. THESE IMAGES APPEARED TO BE SATISFACTORY, HOWEVER AT THIS TIME THE NEUROMONITOR ANNOUNCED THAT HE WAS NOTICING CHANGES TO THE PATIENT SIGNALS. DR (B)(6) THEN ASKED FOR O-ARM TO RETURN TO ROOM FOR CT SPIN. INSPECTION OF THE SCAN SHOWED MEDIAL BREACH OF PEDICLES OF T10-T12 ON RIGHT. THE LEFT SIDE SCREWS ALSO APPEARED TO BE UNIFORMLY LATERAL TO THE PLAN. ALL SCREW TRAJECTORIES APPEARED TO MATCH THE SAME TRAJECTORY ANGLES OF THE PLAN CREATED AFTER THE SPIN BUT WERE SHIFTED SLIGHTLY TO THE LEFT IN REFERENCE TO THE PATIENT'S SPINE. CORRECTIONS MADE: DR. (B)(6) PROCEEDED TO REMOVE THE RIGHT T10-T12 SCREWS. NEUROMONITORING NOTED THAT THE SIGNALS IMPROVED. MIDLINE INCISION WAS MADE OVER THORACIC LEVELS TO PERFORM ADDITIONAL DECOMPRESSION AND REMOVAL OF A HEMATOMA (KNOWN TO BE PRESENT PRIOR TO THE CASE AT T11). NO CEREBRAL SPINAL FLUID LEAKS WERE NOTED. SCREWS (T10-T11 ON RIGHT) AND BOTH RODS WERE REPLACED UNDER FLUORO X-RAY. PATIENT WAS THEN SENT FOR A POST-OP MRI AND WAS DETERMINED TO NOT SHOW SIGNS OF ANY OTHER CONCERNS FROM BREACH OF PEDICLES. DEBRIEF WITH DR (B)(6) WAS DONE TO HELP DETERMINE POSSIBLE CAUSES AND ANY STEPS TO TAKE TO MITIGATE CHANCE OF THESE ADVERSE EVENTS OCCURRING IN FUTURE CASES. DISCUSSION OF THE CASE SET UP, PLACEMENT OF SPINOUS PROCESS CLAMPS, DRB AND ICT, INTRAOP CT SCAN PROCEDURE, INSTRUMENT USE TECHNIQUES, AND CHECKING OF LANDMARKS WERE ALL DISCUSSED. FOLLOWING THIS DISCUSSION ONE POINT THAT BECAME MOST LOGICAL WAS AN ICT FRAME SHIFT POTENTIALLY OCCURRED FROM THE CLOTH PLACED OVER THE ARRAYS DURING THE O-ARM SPIN. DRB SHIFT WAS RULED OUT SECONDARILY DUE TO NO PRESENCE OF WARNINGS NOR INACCURATE DISPLAY WHEN LANDMARK PROB TOUCHED THE SCREW HEADS." }, { "mdr_text_key": "362159848", "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 A SMALL SHIFT IN THE REGISTRATION WHILE BEING TRANSFERRED FROM THE ICT TO THE DRB. A SHIFT OF THE ICT OR DRB CAN LEAD TO NAVIGATIONAL INACCURACIES AND 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": "" } ] }