(b)(4) the device was not received for evaluation as it was implanted.The device history records for the lot were reviewed and verified that the type of low density polyethylene ldpe bag that used to package this device was the version of the bag that has experienced this known issue.The device was used for treatment.No additional complaints have been received against this manufacturing lot, which was manufactured in june of 2012.This issue has been previously investigated and as part of corrective action, a new supplier for the polyethylene bags has been selected and testing completed to ensure thermal reliability and stability of the new bags.Field action z-0845-2016 was initiated on january 11, 2016 to remove remaining affected units from the field.This field action contains the related part and lot number.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.
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