The reported adverse event is associated with a product that was not returned, or was not made available for analysis.The manufacturer investigation was based on the available clinical information.The reported issue is a known medical complication and no specific device analysis is deemed necessary at this time.This report is submitted on november 8, 2017, by cochlear ltd.On behalf of cochlear americas.(b)(4).
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Per the clinic, the patient experienced a wound healing impairment with intermittent discharge, following removal of the abutment due to non-use.Subsequently, the implant fixture was explanted on (b)(6) 2017.There are currently no plans to reimplant the patient with another device, as of the date of this report.
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