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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)
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Event Type
Injury
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Manufacturer Narrative
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510k: this report is for an unknown rafn nail/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 an unknown procedure with retrograde approach for femoral shaft and ipsilateral femur/tibia.There was a union reported postoperatively.Postoperatively, on unknown date, the patient experienced a delayed union and i&d of infected morel-lavallee/hematoma.She was re-admitted for drainage of morel-lavalle fluid collection and there was nothing required surgically for the delayed union.There was an evidence of healing reported.This report is for one (1) unknown retrograde/antegrade femoral nail (rafn).This is report 1 of 4 for (b)(4).
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Search Alerts/Recalls
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