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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
joint, knee, external brace
Product Code
ITQ
Regulation Number
890.3475
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
76
76
2020
22
22
2021
4
4
2022
5
5
2023
75
75
2024
69
69
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Problem
141
141
Unintended System Motion
140
140
Adverse Event Without Identified Device or Use Problem
75
75
No Apparent Adverse Event
46
46
Patient Device Interaction Problem
8
8
Break
5
5
Detachment of Device or Device Component
3
3
Collapse
2
2
Patient-Device Incompatibility
2
2
Insufficient Information
2
2
Defective Device
2
2
Material Twisted/Bent
2
2
Fracture
2
2
Device Slipped
1
1
Unstable
1
1
Physical Resistance/Sticking
1
1
Crack
1
1
Unintended Movement
1
1
Device Fell
1
1
Defective Component
1
1
Material Integrity Problem
1
1
Contamination /Decontamination Problem
1
1
Misassembled During Installation
1
1
Use of Device Problem
1
1
Failure to Align
1
1
Inadequacy of Device Shape and/or Size
1
1
Unexpected Therapeutic Results
1
1
Component Incompatible
1
1
Loose or Intermittent Connection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
141
141
Damage to Ligament(s)
62
62
Injury
9
9
Fall
6
6
No Consequences Or Impact To Patient
4
4
Patient Problem/Medical Problem
3
3
No Known Impact Or Consequence To Patient
3
3
Insufficient Information
3
3
Laceration(s)
3
3
Pain
3
3
Tissue Damage
3
3
Joint Dislocation
2
2
Bone Fracture(s)
2
2
Hematoma
2
2
Swelling
2
2
Neuropathy
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Hypersensitivity/Allergic reaction
1
1
Convulsion, Clonic
1
1
Hip Fracture
1
1
Fungal Infection
1
1
Sprain
1
1
Inflammation
1
1
Edema
1
1
Blister
1
1
Rash
1
1
Convulsion, Tonic
1
1
Thrombosis/Thrombus
1
1
Limb Fracture
1
1
Unspecified Tissue Injury
1
1
Swelling/ Edema
1
1
Skin Tears
1
1
Ambulation Difficulties
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DeRoyal Industries Inc
II
Dec-19-2019
2
Mueller Sports Medicine, Inc
II
Jun-30-2020
-
-