Perforator was received for evaluation: dhr - the lot number was not provided, therefore a dhr review could not be completed.Failure analysis - unit was found to meet all acceptance criteria.The complaint could not be verified through failure analysis.Root cause - the cause cannot be confirmed, as no issues relevant to the failure were noted from the failure analysis or trending.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Between (b)(6)2019 and (b)(6)2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr (b)(4) and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period (b)(6)2019 through (b)(6)2020.Integra lifesciences contacted (b)(6), director of regulatory programs, office of product evaluation and quality and (b)(6), assistant director, mdr team, office of product evaluation and quality on (b)(6)2020 to report these issues regarding mdr reports.
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