{ "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. 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IT WAS REPORTED THAT WHILE USING THE EXCELSIUSGPS SYSTEM, DURING INITIAL STARTUP OF THE SYSTEM, THE MONITOR REMAINED BLACK AND THE USER COULD NOT MOVE THE ROBOT ARM OR ENGAGE STABILIZERS. THIS RESULTED IN THE ABORTION OF THE CASE, AND SCREWS WERE PLACED USING THE TRADITIONAL FREEHAND TECHNIQUE. THE COMPUTER, PIB MODULE, AND CONTROL PANEL WERE REPLACED. NO FURTHER ISSUES HAVE BEEN REPORTED AND THE SYSTEM IS FULLY OPERATIONAL. 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." }, { "mdr_text_key": "364558556", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND. THIS EVENT OCCURRED IN GERMANY." }, { "mdr_text_key": "355537087", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE." }, { "mdr_text_key": "355537088", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND. THIS EVENT OCCURRED IN GERMANY." } ], "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": "02/18/2025" } ] }