{ "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": "3004142400-2024-00427", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250128", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20230404", "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": "20250128", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "801674", "implant_date_year": "2023", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20250128", "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-0377", "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": "20250128", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "13 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Spinal Column Injury", "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20250128", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "21255777", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250127", "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": "362383607", "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 VERIFY A SYSTEM MALFUNCTION. INVESTIGATION OF THE PRE-OPERATIVE SCAN SHOWED THAT THE SCAN APPEARED LOW QUALITY WITH ARTIFACT FROM HARDWARE, MAKING IT MORE DIFFICULT FOR THE SOFTWARE TO IDENTIFY PATIENT ANATOMY SUCH AS PEDICLES AND ENDPLATES. POOR SCAN QUALITY CAN ALSO EFFECT THE MERGE WHICH CAN LEAD TO ISSUES WITH NAVIGATIONAL INTEGRITY. ULTIMATELY, THE USER WAS UNABLE TO RESOLVE THE SCAN QUALITY ISSUES WITHIN THIS CASE AND THE PROCEDURE WAS ABORTED. THERE WERE NO REPORTED ADVERSE EFFECTS 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": "362383608", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "PRE OP CASE. PEDIATRIC SCOLI. 13 Y.O. FAMALE. T5-L5 PEDICLE SCREWS MIS. 2021R1P1. PHILIPS PULSERA C-ARM 12 INCH. DR.(B)(6) WORKFLOW FOR THIS KIND OF CASES ITS TO START FROM TORACIC SCREWS CLAMPING DRB ON T11 AND SM T10 CAMERA TO THE FEET AND ROBOT COMING FROM THE HEAD OF THE PATIENT. FOR LOWER LEVELS HE LIKES TO INVERT POSITION TO DRB AND SM IN ORTHER TO USE THE SAME SPINOUS PROCESSES AND NOT HAVING TO MAKE OTHER INCISIONS TO PEDIATRIC PATIENTS. WE TOOK APS AND LATERALS SHOTS AS USUAL. THE MERGE WAS SHOWING SHIFT ON LATERAL IMAGES FOR T5 AND T10. WE CHOOSE A NEW AP FOR T5 AND IT MERGED WELL. WE DECIDED TO DO NOT TAKE NEW SHOTS FOR T10, THE IDEA WAS TO MERGE T10 WITH THE SECOND SECTION OF THE COLUMN T10-L4/L5. WE STARTED PLACE SCREWS FROM T5 BOTH SIDES. ALL GOOD SINCE T8. WHEN WE INSERTED HIGH SPEED DRILL IN THE EE WE NOTICE THAT NAVIGATION WAS NOT PRECISE. SO WE MOVED AWAY EE AND WE PERFORMED NAVIGATION CHECK BY USING NAVIGATED INSTRUMENT. WE NOTICED AN INCH OF DIFFERENCE BETWEEN WHERE WE WERE WITH THE INSTRUMENT FROM WHAT WE SAW ON THE SCREEN. THE DISCREPANCY SEEMED TO BE ON THE DEPTH. THE INSTRUMENT IN CONTACT WITH THE PATIENT'S ANATOMY WAS ON THE SCREEN ABOUT A CENTIMETER AWAY. I DID A RESET BY SWITCHING TO CRANIAL AND THEN BACK TO SPINE. THIS RESET SEEMED TO HAVE SOLVED THE PROBLEM. WE DID A LANDMARK CHECK WITH SEVERAL INSTRUMENTS AND THEY SEEMED ACCURATE BUT, SINCE WE CALLED THE EE IN TRAJECTORY AND INSERTED THE INSTRUMENT INTO IT, THE INACCURACY OF ONE CENTIMETER CAME BACK. I DECIDED TO REPEAT THE RESET, AGAIN THE NAVIGATION RETURNED ACCURATE AND AGAIN, USED THE EE , THE DISCREPANCY CAME BACK. I THEN DECIDED TO CHANGE THE EE, AND ONCE ACTIVATED IT THE DEPTH OF NAVIGATION SEEMED BETTER BUT NOT PERFECT. I THEN WENT BACK TO REGISTER AND NOTICED THAT ON THE LATERAL IMAGE OF T8 THERE WAS A SHIFT THAT DURING THE MERGE VERIFICATION WE DID NOT REMEMBER THERE WAS. I THEN SELECTED ANOTHER T8 AP FROM THE SAVED IMAGES, REMADE MERGE AND AT THIS TIME THE NAVIGATION WAS ACCURATE AND WE POSITIONED THE SCREW PERFECTLY. THE PROCEDURE CONTINUED BY MOVING THE CAMERA TO THE PATIENT'S HEAD AND THE ROBOT TO THE FEET. THE SURGEON REVERSED THE POSITION OF THE DRB (T10) AND THE SM (T11). WE THEN TOOK THE SHOTS FROM L5 TO T10. ALL SHOTS WERE TAKEN WITHOUT THE ABILITY TO MOVE THE BED THAT WAS NOT WORKING. SO IT WAS COMPLICATED TAKING THE SIDE SHOTS BUT AS YOU CAN SEE DURING YOUR INVESTIGATION WE WERE ABLE TO TAKE SOME DECENT SHOTS. AFTER THE MERGE WE NOTICED THAT T10-11-12 WERE GOOD WHILE ALL OTHER LEVELS HAD IMPORTANT SHIFTS ON THE SIDE IMAGES. WE TOOK NEW SHOTS BOTH APS AND LATERALS, REMADE THE MERGE SEVERAL TIMES, PUT BACK NEW CENTROIDS, I NEVER MANAGED TO GET A GOOD MERGE. WHILE THE APS WERE GOOD FOR ALL LEVELS THE LATERALS ALWAYS HAD BIG SHIFTS AND THE CENTROID ALWAYS SEEMED STRANGELY OUT OF PLACE. A VERY STRANGE FACT THAT WE NOTICED IS THAT DURING THE FIRST MERGE ATTEMPT IF FOR EXAMPLE WE CHECKED THE IMAGES OF T11 AND T12 THAT SEEMED PERFECTLY OVERLAPPING AND THEN WE SELECTED THE VERIFICATION BUTTON GIVING IT THE GREEN CHECK MARK AND THEN WE PASSED TO CHECK THE IMAGES OF L1 THAT INSTEAD ON THE LATERALS SHOWED THE SHIFT, IF WE WENT BACK TO CHECK T12 OR T11, IT WAS NOW SHOWING A SHIFT ON THE LATERALS ALSO ON THESE LEVELS. AT THAT POINT THE SURGEON DECIDED TO PLACE THE SCREWS FROM T10 TO L5 OLD WAY. I DECIDED NOT TO TRY A HARD SHUT DOWN FOR TIME REASONS." } ], "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": "" } ] }