Mayfield modified skull clamp (a1059 ) has been returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the complaint is confirmed via inspection of the unit.The investigation showed that the lock had rotational and lateral movement and a residue buildup was present.To resolve the issue, new components were added to replace all worn internal parts, and general maintenance and cleaning has been performed.Root cause - root cause is routine use and wear resulting in movement in the lock which required parts replacement.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
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