It was reported that a patient underwent an unknown neurological procedure on an unknown date and bone wax was used.During the procedure, the bone wax was not sticking to the bone.As they were applying it, it was simply coming off as they move along the bone.The procedure was completed with a different device.There were no adverse patient consequences reported.
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(b)(4).An unopened sample of product code w31, lot # al1661 was received for evaluation.During the visual inspection of the sample, no defects were observed on the packet, the sample was opened, and the appearance and consistency of the bonewax bar were conforming the requirements.According to samples condition, no performance nonadherence were noted.A manufacturing record evaluation was performed for the finished device al1661 number, and no non-conformances were identified.
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