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.(b)(4).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 unknown date, the patient underwent hardware removal of right 10 hole variable angle condylar plate and unknown screws, due to the implant irritating the patient.The plate and screws were implanted on an unknown date.The devices were completely taken out and no other product was implanted.The procedure outcome and patient status are unknown.This report involves 4.5mm va-lcp curved condylar plate/10 hole/230mm/right.This is report 1 of 2 for (b)(4).
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