The investigation could not be completed; no conclusion could be drawn, as no product was received.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 due to acoustic neuroma.The patient was implanted with unknown bone plates and cranios reinforced fast sst putty.The procedure was successfully completed.There were no post-operative complications.Other outcome assessments or patient-reported outcomes were decreased peripheral vision on the right, headaches, decreased appetite, first bite syndrome, gait unsteady, dysphonia, contralateral vocal cord paralysis, diplopia on lateral gaze to the right (right vi parietal) in right lateral gaze, endgaze nystagmus, and amplitude skew deviation.He is experiencing oscillopsia in the right lateral gaze.Any further procedure or patient outcomes were not reported.Concomitant devices reported: unknown screw (part # unknown, lot # unknown, quantity # 1), cranios reinforced fast set putty 5cc-sterile (part # 615.05.01s, lot # dsc3595/ dsc6246, quantity # 2).This report is for one (1) ti low profile neuro adaption plate 20 holes.This is report 2 of 4 for (b)(4).
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