The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr): the manufacturing process and final device inspection ensures that non-conforming product is not released into the distribution chain.Failure analysis - complaint confirmed via inspection of the unit.Unit received with the lock having movement, requiring replacement of worn internal parts.Unit received with the lock having rotational and lateral movement and a residue buildup was present.General maintenance and cleaning performed and new components have been added to replace worn internal parts.Root cause - complaint confirmed via inspection of the unit.Unit received with the lock having movement, requiring replacement of worn internal parts.This unit is beyond integra¿s 7 years recommended life cycle (manufactured 2000).Probable root cause is routine use and wear.
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