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: 1627487-2022-02035.It was reported that the patient experienced pain at the anchor site.Visual inspection confirmed the anchors had migrated across the midline.In turn, surgical intervention was undertaken on (b)(6) 2022 wherein the anchors were repositioned.Post-operatively, the pain resolved.
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