The reported event could not be confirmed.Further information (e.G.Initial implantation date, postoperative images after initial implantation, surgeon¿s reports) was requested regarding the reported event.The sales rep was asked to fill-out the ¿infection complaints ¿ checklist customer¿ (cmfqf 13-0003).However, no further information was received.The ¿infection complaints ¿ checklist investigator¿ (cmfqf 13-002) was completed by the manufacturer for the affected device.For infection complaints expanded investigations were performed.This is to assure that neither the reported device nor all related manufacturing (e.G.Environmental monitor-ing, sterilization validations tests) process steps could have caused the event.Indications for any device or manufacturing problems were not found.The reported device is delivered non-sterile.The related instructions for use (90-02023) include the appropriate cleaning, disinfection, and sterilization instructions.The evaluation has shown that there are no indications for any systematic design, material, or manufacturing related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.
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