MalfunctionISH
OTTO BOCK AXTION® PROSTHETIC FOOT
Received Jul 20, 2016 · Event occurred Dec 2, 2013
Report 1721652-2016-00005 · MDR key 5809713
Device
Generic name
1e56 Axtion Prosthetic Foot
Manufacturer
Otto Bock Healthcare LpModel number
1E56=N27-4-P/0Catalog number
1E56=N27-4-P/0
Product problems
- Break
Patient
68 YR
- 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.
Description of Event or Problem
PATIENT: BILATERAL, (B)(6) KG, WITHOUT WARNING THE ADAPTER BROKE AND THE PATIENT FELL. NO INJURIES OR HARM REPORTED. LOCATION OF THE ACCIDENT: AT HOME.
Remedial action
- Replace