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
prosthesis, wrist, carpal trapezium
Product Code
KYI
Regulation Number
888.3770
Device Class
2
Premarket Reviews
Manufacturer
Decision
ASCENSION ORTHOPEDIC
SUBSTANTIALLY EQUIVALENT
1
ENSEMBLE ORTHOPEDICS, LLC
SUBSTANTIALLY EQUIVALENT
1
EXTREMITY MEDICAL LLC
SUBSTANTIALLY EQUIVALENT
1
SKELETAL DYNAMICS, LLC
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
4
4
2016
3
3
2018
4
4
2019
14
14
2020
8
8
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
10
10
Appropriate Term/Code Not Available
7
7
Insufficient Information
3
3
Break
3
3
Migration or Expulsion of Device
2
2
Metal Shedding Debris
2
2
Device Operates Differently Than Expected
2
2
Device Dislodged or Dislocated
2
2
Device Contamination with Chemical or Other Material
1
1
Material Integrity Problem
1
1
Nonstandard Device
1
1
Labelling, Instructions for Use or Training Problem
1
1
Inadequate Instructions for Healthcare Professional
1
1
Packaging Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
9
9
Injury
9
9
Joint Dislocation
6
6
No Known Impact Or Consequence To Patient
5
5
Bone Fracture(s)
2
2
Unspecified Infection
2
2
Inflammation
1
1
Wound Dehiscence
1
1
Test Result
1
1
No Code Available
1
1
Unspecified Tissue Injury
1
1
Impaired Healing
1
1
Ambulation Difficulties
1
1
Limited Mobility Of The Implanted Joint
1
1
Patient Problem/Medical Problem
1
1
Swelling
1
1
Burning Sensation
1
1
No Consequences Or Impact To Patient
1
1
Discomfort
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ascension Orthopedics, Inc
II
Nov-22-2010
2
Integra LifeSciences Corp.
III
Jun-21-2013
3
Wright Medical Technology, Inc.
II
Nov-25-2019
-
-