Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
orthosis, corrective shoe
Regulation Description
Limb orthosis.
Product Code
KNP
Regulation Number
890.3475
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
6
6
2021
3
3
2022
8
8
2023
1
1
2024
16
16
2025
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
18
18
Patient Device Interaction Problem
11
11
Insufficient Information
5
5
Break
2
2
Detachment of Device or Device Component
1
1
Inadequacy of Device Shape and/or Size
1
1
Mechanical Problem
1
1
Use of Device Problem
1
1
Material Twisted/Bent
1
1
Loose or Intermittent Connection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Ulcer
10
10
Pressure Sores
7
7
Tissue Breakdown
6
6
Neuropathy
4
4
Abrasion
4
4
Unspecified Tissue Injury
3
3
Laceration(s)
2
2
Pain
2
2
Fall
2
2
Bone Fracture(s)
2
2
Unspecified Infection
2
2
Insufficient Information
2
2
Injury
2
2
Thrombosis/Thrombus
1
1
Limb Fracture
1
1
Muscle/Tendon Damage
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Skin Inflammation
1
1
Sleep Dysfunction
1
1
-
-