Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Muscle Weakness (1967)
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Event Date 07/24/2021 |
Event Type
Injury
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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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It was reported that following an implant procedure on (b)(6) 2021 the patient experienced leg weakness.Upon further investigation, it was concluded that the patient had an epidural hematoma.As a result, surgical intervention was undertaken on (b)(6) 2021 wherein the entire system was explanted.The issue has since been resolved.
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Event Description
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Additional information indicates the patient did not experience a hematoma or any surgical intervention on the system.
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Manufacturer Narrative
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Additional information the patient did not experience a hematoma or any surgical intervention on the system.This event is no longer reportable.
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Search Alerts/Recalls
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