The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - investigation of the returned unit was unable to duplicate slippage.The lock had both rotational and lateral movement and a residue buildup was present; however, when properly positioned and put under pressure, the device would not move.Unit was machined to have heli-coils added to large starburst threads.New components were added to replace worn internal parts, and general maintenance and cleaning were performed.Root cause: the reported complaint is not confirmed.Evaluation found no device deficiencies that would have contributed to the reported complaint.Probable root cause of the reported complaint is improper or suboptimal positioning of the skull clamp on the patient.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
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