{ "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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HE WAS NOT CONFIDENT WITH THE ACCURACY AND SAFETY CHECKS. THE ENTIRE SURGERY WAS ABORTED AND THE PATIENT WAS ALREADY UNDER ANESTHESIA." }, { "mdr_text_key": "402035462", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO CASE LOGS WERE SUBMITTED, SO A FORMAL INVESTIGATION COULD NOT BE PERFORMED. THE USER REPORTED A LOSS OF NAVIGATIONAL INTEGRITY. THE USER ACKNOWLEDGES THAT THEY WILL PERFORM AN ANATOMICAL LANDMARK CHECK WITH EACH NEW INSTRUMENT OR LEVEL TO ENSURE NAVIGATIONAL INTEGRITY BEFORE PROCEEDING WITH NAVIGATION. ULTIMATELY, THE CASE WAS COMPLETED WITH NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THIS EVALUATION HAS BEEN COMPLETED WITHOUT ASSOCIATED CASE LOGS AND THERE ARE NO ASSOCIATED WORK ORDER OR PART RETURNS. THE SEVERITY OBSERVED DID NOT EXCEED THE ANTICIPATED SEVERITY. THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH DOES NOT EXCEED THE OBSERVED ANTICIPATED RISK LEVEL; THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED. THE FOLLOWING SECTIONS WERE UPDATED FOR THIS SUPPLEMENTAL REPORT: B4, G3, G6, H2, H3, H6, H10." }, { "mdr_text_key": "396214682", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING AN EXCELSIUS GPS SURGERY, THE SURGEON DECIDED TO ABORT A EXCELSIUS GPS SI LOK SURGERY ON (B)(6) 2026. HE WAS NOT CONFIDENT WITH THE ACCURACY AND SAFETY CHECKS. THE ENTIRE SURGERY WAS ABORTED AND THE PATIENT WAS ALREADY UNDER ANESTHESIA." }, { "mdr_text_key": "396214683", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE WAS UNAVAILABLE FOR EVALUATION. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE." } ], "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": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/15/2026" } ] }