It was reported that the fellow made first three burr holes and they were fine.Resident then proceeded to use the codman perforator and fourth burr hole did not stop and kept going, and there was damage to the dura matter.Perforator was retracted.A second perforator was opened and worked well to complete the surgery.The surgery that was performed was a craniotomy, meningioma-frontal craniotomy for resection of anterior skull base meningioma.The standard default setting drill used was the anspach drill the fellow did pre-test of the perforator, by pushing down on inner drill to ensure it moved.There is evidence on ct scan of damage on the lt dominant side.
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Failure analysis - complaint could not be verified.Unit was found to meet all acceptance criteria.The cause cannot be confirmed, as no issues relevant to the failure were noted from the dhr review, trending, or failure analysis, and proper finished goods testing was performed prior to release as indicated in the dhr.Between 05nov2019 and 30jun2020, 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 229048 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 05nov2019 through 30jun2020.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 july 8-9, 2020 to report these issues regarding mdr reports.
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