OTTO BOCK AXTION® PROSTHETIC FOOT
Received Jul 21, 2016 · Event occurred Mar 13, 2014
Report 1721652-2016-00006 · MDR key 5813746
Device
Generic name
1e56 Axtion Prosthetic Foot
Manufacturer
Otto Bock Healthcare LpModel number
1E56=N28-5-P/0Catalog number
1E56=N28-5-P/0
Product problems
- Break
Patient
Not reported
- Injury
- Injury
Narrative
Additional Manufacturer Narrative
RECENTLY OTTO BOCK HEALTHCARE LP PERFORMED A RETROSPECTIVE REVIEW ACROSS ALL PRODUCTS MANUFACTURED IN (B)(4). DURING THE REVIEW THIS MALFUNCTION WAS DISCOVERED AND IT WAS DETERMINED TO BE REPORTABLE BASED ON THE CRITERIA OUTLINED IN 21 CFR 803. DEVICE WAS NEVER RETURNED.
Description of Event or Problem
THE PATIENT WAS WEARING THE FOOT DURING A PYRAMID BREAK. THE PATIENT WAS SAID TO HAVE EXPERIENCED AN INJURY DUE TO THE PYRAMID BREAKING, BUT THIS WAS NEVER ABLE TO BE CONFIRMED THROUGH COMMUNICATION REQUESTS. OUT OF AN ABUNDANCE OF CAUTION THIS COMPLAINT WAS REPORTED AS AN MDR.
Remedial action
- Replace