Related manufacturer report numbers: 3006705815-2022-01484, 3006705815-2022-01485, 3006705815-2022-01486, and 1627487-2022-01584.It was reported that the patient experienced an infection.In turn, surgical intervention was undertaken wherein the system was explanted.The infection has since resolved.
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A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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