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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Arthritis (1723)
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Event Type
Injury
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Manufacturer Narrative
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510k: this report is for an unknown spring plate/unknown lot.Part and lot number are unknown; udi number is unknown.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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Event Description
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It was reported that on an unknown date, the patient underwent a surgical procedure for fracture fixation of acetabulum, utilizing two (2) spring plates and two (2) recon plates.Postoperatively, the patient had severe oa and was converted to a tha.It is unknown if there was a surgical delay reported.No further information is available.This report is for an unknown spring plate.This is report 1 of 5 for (b)(4).
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Search Alerts/Recalls
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