{ "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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THE PURPOSE OF THIS INVESTIGATION IS TO EVALUATE THE RISK ASSOCIATED WITH THE IDENTIFIED FAILURE MODE OF NAVIGATIONAL INTEGRITY. THE USER REPORTED THAT THIS PATIENT HAD PARTICULARLY HARD BONE AND A STEEP ANGLE OF THE SACRUM, WHICH CAN CONTRIBUTE TO SKIVING. ADDITIONALLY, INVESTIGATION OF THE CASE LOGS SHOWED THAT THE SOFTWARE DETECTED EXCESSIVE FORCES ON THE LOAD CELL DURING BONE WORK. THIS IS THE RESULT OF SKIVING FORCES DETECTED WHILE A TOOL IS INSERTED INTO THE END EFFECTOR. THE SOFTWARE CORRECTLY DETECTED THIS FORCE AND ALERTED THE USER. THE OVERALL ANTICIPATED RISK LEVEL IS LOW. THE SEVERITY OBSERVED DID NOT EXCEED THE ANTICIPATED SEVERITY. THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED AND THERE IS NO FURTHER INVESTIGATION REQUIRED. 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