The mayfield modified skull clamp (a1059) was returned for evaluation: failure analysis: the investigation of the returned device showed that the lock had lateral and rotational movement.When the lock was disassembled, there was a residue buildup.All worn components were replaced with new parts; general maintenance and cleaning also performed.Root cause analysis: complaint confirmed via inspection of the item.Unit received with the lock having lateral and rotational movement and a residue buildup was present.This unit is beyond integra¿s 7 years recommended life cycle (manufactured (b)(6)), thus required preventive maintenance, cleaning and replacement of worn components.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
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