It was reported the patient experienced redness and pain at the right anchor implant site, it was determined an infection was present.As a result, surgical intervention was undertaken on (b)(6) 2022 wherein the anchor was repositioned and the wound irrigated resolving the issue.
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An event of infection was reported to abbott.It was conveyed that the infection originates at the anchor site(s); however, no explanted products were returned for analysis.As a result, the anchor was repositioned and the wound irrigated resolving the issue.As a result, a device history record was performed to review and confirm the sterility of the anchor(s).Based on the documents reviewed, the source of the infection remains unknown.
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