(b)(4) combined report.It was reported that patient is (b)(6), with an unknown level of activity.The primary surgery used ops technology.Additional information, including post primary and pre revision x-rays, operative notes, and an update on the patient following the revision have been requested, but were not provided.The explanted devices were not available to be returned for examination.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, cleaned, packaged and sterilised in accordance with the correct specifications at the time of manufacture.The sterilization method and sterile barrier system used to package trinity devices has a long history of safe and effective use at corin and has been validated in accordance with the relevant standards.Based on the available information no further investigation can be conducted.Infection is a known complication with any invasive surgery and thus this case is now considered closed, however, should any additional information be provided then this case may be re-opened for further investigation.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.
|