Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 Back to Search Results
Device prosthesis, toe, hemi-, phalangeal
Product CodeKWD
Regulation Number 888.3730
Device Class 2


Premarket Reviews
ManufacturerDecision
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
-
-