{ "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. THE SOFTWARE DETECTED AND ALERTED THE USER OF EXCESSIVE DEFLECTION FORCES ON THE LOAD CELL. THIS IS THE RESULT OF SKIVING FORCES DETECTED WHILE A TOOL IS INSERTED INTO THE END EFFECTOR. SKIVING CAN LED TO THE MISPLACEMENT OF SCREWS. THE SOFTWARE CORRECTLY DETECTED THE FORCE AND ALERTED THE USER OF IT. THE USER REPLACED THE MISPLACED IMPLANTS USING TRADITIONAL MIS TECHNIQUES. ALL OTHER IMPLANTS WERE PLACED ACCORDING TO PLAN WITH NO ADVERSE EFFECTS TO THE PATIENT. THE SEVERITY IS OBSERVED DID NOT EXCEED THE ANTICIPATED SEVERITY. 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. 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