This report is for an unknown matrixmidface screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported that on an unknown date, the patient underwent an acoustic neuroma resection retrosigmoid procedure.Patient was implanted with an unknown bone plates and putty cement.Postoperatively, the patient's surgery was complicated by swelling of the neck which required the patient to be kept intubated for an extra two days for airway protection.The patient's shoulder was mildly weak after the surgery and was attributed to brachial plexus stretch injury.The patient is making good progress and the post operative complications were resolved.Patient's outcome is unknown.This is report 3 of 3 for (b)(4).This report is for matrixmidface screw.
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