OTTO BOCK AXTION® PROSTHETIC FOOT

Additional Manufacturer Narrative

IT WAS DISCOVERED ON 11/13/2018 THAT THE ORIGINAL SUBMISSION WAS NOT ACCEPTED DUE USE OF AN INCORRECT ICSR VERSION. ICSR R2 IS NOW REQUIRED. I RE-INSTALLED ESUBMITTER IN HOPES THE PROBLEM IS RESOLVED AND MY SUBMISSION WILL BE ACCEPTED. THE CDRH EMDR HELP DESK SUGGESTED THE RE-INSTALLING OF THE ESUBMITTER WOULD RESOLVE THIS ISSUE. [(B)(4)].

Description of Event or Problem

MULTIPLE ATTEMPTS TO SEEK INFORMATION REGARDING THE SPECIFIC EVENT(S) SURROUNDING THIS FAILURE WERE UNSUCCESSFUL. REGARDLESS OF THESE ATTEMPTS, A FALL OR INJURY WAS NEVER REPORTED OR CONFIRMED AS THIS COMPLAINT WAS BEING HANDLED. THE CUSTOMER REPORTED INFORMATION THAT THE FOOT WAS BEING USED WITHIN INDICATIONS. WEIGHT, ACTIVITY LEVEL, AND NORMAL ACTIVITIES (WALKING ON "ROAD, PATH, MEADOW AT HOME") REPORTED WERE ALL WELL WITHIN THIS FOOT'S INTENDED USE. THIS FAILURE OCCURRED WITHIN THE INTENDED USE-LIFE FOR THIS FOOT. OUT OF AN ABUNDANCE OF CAUTION, THIS COMPLAINT IS BEING REPORTED AS AN MDR SINCE THIS CONFIRMED DEVICE FAILURE HAS DEMONSTRATED THE RISK OF CAUSING SERIOUS INJURY TO THE END-USER.