Mayfield modified skull clamp (a1059) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history records (dhr) were reviewed and found no anomalies.The root cause of the reported issue could not be determined.However, based on the reported complaint, probable root cause is improper or suboptimal positioning of the skull clamp on the patient.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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