Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Implant Pain (4561)
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Event Date 11/22/2022 |
Event Type
Injury
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Manufacturer Narrative
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Exact date of event is unknown.
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Event Description
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Related manufacturer reference number: 1627487-2022-06611 it was reported that the patient experienced pain at their anchor site.Surgical intervention may occur in the future to address the issue,.
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Manufacturer Narrative
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During processing of this complaint, attempts were made to obtain complete patient information.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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Manufacturer Narrative
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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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Event Description
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Additional information was received that the patient underwent a surgical procedure on (b)(6) 2023 during which the anchors were explanted and replaced to address the issue.
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Search Alerts/Recalls
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