Mayfield modified skull clamp (a1059) was not returned for evaluation; therefore, an evaluation of the device could not be performed.However, investigation using an image provided by the customer was performed as follows: device history record (dhr) review: lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.Failure analysis: the evaluation confirmed the reported condition from the image provided.The spring came out of the a1059 skull clamp.The observed condition is consistent with improper handling.Root cause - the definite root cause cannot be reliably determined.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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