{ "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 CASE LOGS INDICATED THAT THE MISPLACEMENT OF THE IMPLANTS WAS DUE TO EXCESSIVE DEFLECTION FORCES ON THE END EFFECTOR, OR SKIVING, WHILE NAVIGATING INSTRUMENTS THROUGH THE END EFFECTOR. THE CASE LOGS FROM THE PROCEDURE SHOWED NUMEROUS WARNINGS STATING THAT EXCESSIVE DEFLECTION FORCE WAS DETECTED WHILE NAVIGATING INSTRUMENTS ON TRAJECTORY. EXCESSIVE DEFLECTION FORCE ON THE END EFFECTOR HAVE THE ABILITY TO CAUSE THE INSTRUMENT TO SKIVE DEPENDING ON THE TECHNIQUE OF THE USER. INSTRUMENT SKIVING CAN LEAD TO THE MISPLACEMENT OF IMPLANTS. THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH MATCHES THE OBSERVED ANTICIPATED RISK LEVEL. 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