Per - (b)(4) 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.The sterilisation method and sterile barrier system used to package trinity devices has a long history of safe and effective use at corin for a wide range of orthopaedic devices and has been validated in accordance with the relevant standards.Infection is a known complication with any invasive surgery and thus this case is considered 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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