Integra has completed their internal investigation on may 3, 2017 results: evaluation of returned device; patency testing showed the received valve was patent (no obstruction).The valve was tested and found within pressure/flow specifications.Each osv ii valve is pressure/flow tested at the end of the manufacturing process.The involved valve osv ii ref 909700, sn (b)(4) was tested within pressure/flow specifications at time of manufacture.Dhr review; the device history records review of the osv ii valve ref 909700, lot # 0188400, s/n (b)(4) were reviewed and did not reveal any anomaly.Complaints history; upon review of integra¿s complaint system from january 2014 ¿ march 24, 2017, a total of nine (9) complaints (including this one) for osv ii valve systems have been reported for obstruction after the implantation procedure.Over (b)(4) units of osv ii valve systems have been sold from january 2014 to march 6, 2017, resulting in a complaint occurrence rate of approximately (b)(4).No adverse trend is observed.Conclusion: as the received valve was found within pressure/flow specifications, the complaint is not verified: the valve testing does not explain the reported obstruction.Given the available information, the exact root cause of this event could not be determined.
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