It was reported that a patient experienced swelling and a local rash at his left ankle implant site and is trying to determine if it is allergy related.A tubular plate, wires and screws were implanted in (b)(6) 2012.The screws were removed in (b)(6) 2013.The plate was removed in (b)(6) 2014.The patient's allergist office requested and was provided with the metal composition make-up of all the implanted components.This is regarding 1 plate, 2 wires and 5 screws.This is report 6 of 7 for the same event, (b)(4).
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This device is used for treatment, not diagnosis.Implant date reported as (b)(6) 2012.Investigation could not be completed and no conclusion could be drawn as no device was returned.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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