Per -2498 combined report: the appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records were manufactured, packaged and sterilised in accordance with the correct specifications.Infection is a known complication with any invasive surgery and thus corin now considers this case closed.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.
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