The device was not returned.With review of the available information, there is no evidence to indicate any device malfunction or performance issues that would impact the reported event.A possible root cause for the damaged tooth can be associated with user error.Possible clinical factors that might have contributed to this event include the patient's pre-existing dental care history.The user indicated from that 80% of the tooth was an amalgam filling and he was not surprised that the small natural aspect of the tooth was damaged.Additionally, the neocis guidance system user manual contraindicates for use in patients that have insufficient bone or teeth to retain a neocis chairside patient splint (cps) rigidly throughout a surgical procedure.No further injury or additional medical intervention has been reported as a result of this event.
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