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.
|
It was reported that on an unknown date, the patient underwent a procedure for a shaft fracture fixation utilizing va-lcp anterior plate.Patient had a increased pain immediately postoperatively, which was resolved by postop week 2.Union was achieved after 8 weeks.No post-operative complications reported.Patient outcome is unknown.This report is for (1) 2.7mm/3.5mm va-lcp lat ant clavicle plate/11h/113mm close.This is report 1 of 10 for complaint (b)(4).
|