A multicenter post market clinical follow-up retrospective study is being performed at specific time points post-implantation to evaluate the safety and performance of the hyprocure implant.The pmcf studies were not requested by fda.The manufacturer was not made aware of these issues prior to the report study and no complaints have been made.The device instructions for use includes a warning - it is very important to selct the correct size of the implant to achieve the best possible correction.All risks have been reduced as low as possible.
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