Related manufacturer reference number: 3006705815-2020-32656, 3006705815-2020-32657, 3006705815-2020-32658, 1627487-2020-47680.It was reported the patient had an infection at an unknown location.In turn, surgical intervention was undertaken wherein the entire system was explanted to address the issue.
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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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