A facility reported that during inspection of the mayfield skull clamp (a1059), a play, or movement in the rocker arm even after locking was observed.There was no patient involvement, or patient injury, and no known delay in surgery.
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Udi: (b)(4).Mayfield modified skull clamp (a1059) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.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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