This is 2 of 3 reports linked to mfg report numbers: 3004608878-2021-00071, 3004608878-2021-00073.A facility reported that mayfield skull clamp (a3059), swivel adaptor and base unit were moving and shifting during a tumor removal procedure.This event occurred after the patient was placed in the skull clamp, and after the surgeon had confirmed navigation.The slightest movement will render these navigation parameters useless.There was no patient laceration and/or other injury and no surgical delay was reported.Additional information has been requested.
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Mayfield skull clamp (a3059) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.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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