{ "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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INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. ENGINEERING DID NOT FIND A SYSTEM MALFUNCTION. INVESTIGATION OF THE CASE SHOWED THE SYSTEM WAS POSITIONED IN SUCH A WAY THAT THE TRAJECTORY WAS UNREACHABLE. ULTIMATELY, THE USER ABORTED EGPS IN THIS CASE AND 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": "362448175", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE MATCHING WAS DONE AND WE STARTED TO APPROACH WITH THE ROBOT. THE SCREWS WERE ONLY NECESSARY ON THE RIGHT SIDE, SO WE GOT ALL THREE RIGHT SCREWS GREEN FRAME AND STABILIZED THE ROBOT IN THAT POSITION. 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