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, toe, hemi-, phalangeal
Product Code
KWD
Regulation Number
888.3730
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACCUFIX SURGICAL INC.
SUBSTANTIALLY EQUIVALENT
1
ACCUFIX SURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
ARTHROSURFACE, INC.
SUBSTANTIALLY EQUIVALENT
3
ASCENSION ORTHOPEDICS, INC.
SUBSTANTIALLY EQUIVALENT
1
BIOPOLY, LLC
SUBSTANTIALLY EQUIVALENT
2
BIOPRO, INC.
SUBSTANTIALLY EQUIVALENT
1
LIFE SPINE INC.
SUBSTANTIALLY EQUIVALENT
1
METASURG
SUBSTANTIALLY EQUIVALENT
1
MONTROSS EXTREMITY MEDICAL
SUBSTANTIALLY EQUIVALENT
1
RESTOR3D, INC.
SUBSTANTIALLY EQUIVALENT
1
SOLANA SURGICAL LLC
SUBSTANTIALLY EQUIVALENT
3
SOLANA SURGICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
VILEX IN TENNESSEE, INC.
SUBSTANTIALLY EQUIVALENT
1
VILEX, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
3
3
2015
10
10
2016
7
7
2017
10
10
2018
8
8
2019
19
19
2020
4
4
2021
2
2
2022
10
10
2023
27
27
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
51
51
Break
13
13
Insufficient Information
8
8
Improper or Incorrect Procedure or Method
6
6
Device Operates Differently Than Expected
5
5
Loose or Intermittent Connection
4
4
Off-Label Use
3
3
Migration or Expulsion of Device
2
2
Difficult to Insert
2
2
Use of Device Problem
2
2
Defective Device
2
2
Patient-Device Incompatibility
2
2
Appropriate Term/Code Not Available
2
2
Patient Device Interaction Problem
1
1
Migration
1
1
Detachment of Device or Device Component
1
1
Material Deformation
1
1
Material Integrity Problem
1
1
Malposition of Device
1
1
Failure to Osseointegrate
1
1
Defective Component
1
1
Dull, Blunt
1
1
Loss of Osseointegration
1
1
Labelling, Instructions for Use or Training Problem
1
1
Device Expiration Issue
1
1
Device Appears to Trigger Rejection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Implant Pain
21
21
Inadequate Pain Relief
17
17
Pain
16
16
No Known Impact Or Consequence To Patient
11
11
Failure of Implant
8
8
Swelling
7
7
Loss of Range of Motion
6
6
No Code Available
6
6
Joint Swelling
6
6
Deformity/ Disfigurement
4
4
Osteolysis
3
3
Insufficient Information
3
3
No Clinical Signs, Symptoms or Conditions
3
3
Swelling/ Edema
2
2
Impaired Healing
2
2
Reaction
2
2
Bone Fracture(s)
2
2
Erythema
2
2
Fatigue
1
1
Fever
1
1
Abdominal Pain
1
1
Adhesion(s)
1
1
Headache
1
1
Hypersensitivity/Allergic reaction
1
1
Unspecified Infection
1
1
Rash
1
1
Scar Tissue
1
1
No Consequences Or Impact To Patient
1
1
Discomfort
1
1
Complaint, Ill-Defined
1
1
Injury
1
1
Arthralgia
1
1
Skin Inflammation
1
1
Ambulation Difficulties
1
1
Inadequate Osseointegration
1
1
Foreign Body In Patient
1
1
Patient Problem/Medical Problem
1
1
Joint Dislocation
1
1
Malaise
1
1
No Information
1
1
Metal Related Pathology
1
1
Skin Infection
1
1
Reaction to Medicinal Component of Device
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
BioPro, Inc.
II
Feb-28-2022
2
Integra LifeSciences Corp.
II
Dec-16-2014
3
Wright Medical Technology, Inc.
II
Nov-25-2019
-
-