A review of the device history records indicated that the graft was processed and inspected according to procedures and was therefore released following acceptable quality inspections and tests.No anomaly was found.An examination of the complaint remaining fragment confirmed the presence of a hole (straight cut) which length measures approximatively 3mm.The product does not comply with its specification.A corrective action has been initiated.This mdr is one of a series of four resubmissions.Indeed, following the fda's email dated june 24th, 2020 informing us on an issue about the initial mdr #16402201-2016-00008 which was not received, and the confirmation of an error of submission environment on july 6th, 2020, an internal non-conformity report was initiated on july 6th, 2020 in order to investigate the root cause of the issue and take appropriate corrective actions.In this context, the mdr # 16402201-2016-00008 was resent on july 10th, 2020 and three additional mdr's were identified as affected by the same discrepancy (original submission in the test environment instead of the production environment): supplemental report 1 for mdr # 16402201-2016-00004.Supplemental report 2 for mdr # 16402201-2015-00024.It is why we are resubmitting today the present report with the original data.Please note that some original data have been changed in this resubmission: email address in and contact name in (updated information).Manufacturing date (changed from 06/30/2015 to 07/30/2015 to reflect labeling) method codes (some original codes are now invalid) and was supplemented to add details concerning the resubmission.We apologize for this issue.
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