Date of event is estimated.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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Related manufacturer reference number: 1627487-2020-48556, 1627487-2020-48555, 1627487-2020-48554.It was reported the patient experienced pain at the anchor site.In turn, the patient underwent surgical intervention on (b)(6) 2020 wherein the anchors were placed deeper to address the issue.It is unknown which anchor is related to the issue.Therefore, all the suspected anchors are being reported.
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