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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It was reported that on an unknown date, the patient underwent a fracture fixation for a shaft fracture utilizing a va-lcp anterior plate.Postoperatively, the patient experienced suture abscess which was resolved.There was a fracture union after an 8 week duration.Patient outcome is unknown.No further information is available.This report is for one (1) 2.7/3.5 va-lcp lat ant clav pl/11h/113.This is report 1 of 1 for (b)(4).
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