Related manufacturer reference numbers: 3006705815-2020-31527.3006705815-2020-31528.It was reported that following an implant procedure on (b)(6) 2020, the patient experienced post-operative pain and a fever.The patient was administered narcotics.As a result, surgery occurred to explant the system 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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