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Description of event: it was reported that during the craniotomy procedure, the burr holes were drilled to access the brain tumor using the midas rex, using a codman 14mm disposable perforator attachment.First burr hole was drilled without any incident, but the during the second burr hole the attachment got stuck, while lodging the perforator in the patient's skull.The perforator could not be manually removed and had to be cut out.It was also reported that intervention was performed, and the procedure was completed with backup product(s).On follow up it was reported that there were no fragments left inside the patient and there was a procedure delay approximately 45 minutes to call up another drill.It was also reported that after operation, the condition of the patient is stable.On further follow-up it was reported that there was no damage to the dura mater or tissue of the patient and to remove the perforator bit out of the skull, it was broken into two pieces.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Refer to add'l documents in i2k.
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