The device was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device, and review of verification and validation testing of the associated manufacturing and sterility processes.The manufacturing process for this device was reinvestigated.There was no sign of any inconsistency during the manufacturing process which might be related to an adverse clinical observation.All production steps had been performed accordingly, including packaging and sterilization.The product was sterilized by eto per a validated method demonstrated to yield a sterility assurance level (sal) of 1 x 10-6 ((b)(4)).The sterile barrier has been demonstrated to be intact up to 36 months after storage in real time aging conditions, as determined for product with the same packaging and sterility parameters ((b)(4)).In summary, the review of the quality documents confirmed a regular device manufacturing.It is presumed that if the sterile barrier was intact up to the time of implant, sterility would not be compromised.
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