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Catalog Number SD800.401 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Date 01/31/2021 |
Event Type
Injury
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that, a patient underwent surgery for 2 peek psi implants in the area of the zygoma - cheekbones about six months ago claims that she still has pain in the area of surgery.According to the surgeon, there is expected to be pain even after about six months from the date of the operation and that no medical problems have been diagnosed.This report is for one (1) psi 30*30*40 peek.This is report 1 of 2 for complaint (b)(4).
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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