OTTO BOCK AXTION® PROSTHETIC FOOT
Received Jul 20, 2016 · Event occurred Mar 11, 2013
Report 1721652-2016-00004 · MDR key 5808542
Device
Generic name
1e56 Axtion Prosthetic Foot
Manufacturer
Otto Bock Healthcare LpModel number
1E56=N26-3-P/0Catalog number
1E56=N26-3-P/0
Product problems
- Break
Patient
Not reported
- Fall
- Fall
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 NOT RETURNED, EVAL FROM PICTURES.
Description of Event or Problem
THIS EVENT OCCURRED IN (B)(6). THE PYRAMID ADAPTER BROKE WHILE THE PATIENT WAS WALKING AT HOME IN THE KITCHEN. THE PATIENT WAS SAID TO HAVE FALLEN AND HURT THEIR HANDS. THERE WERE NO SERIOUS INJURIES REPORTED AND THE PATIENT DID NOT SEEK MEDICAL ATTENTION. NO FURTHER DETAILS WERE PROVIDED FOR THIS EVENT.
Remedial action
- Replace