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, wrist, carpal trapezium
Product CodeKYI
Regulation Number 888.3770
Device Class 2


Premarket Reviews
ManufacturerDecision
ENSEMBLE ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 8 8
Appropriate Term/Code Not Available 7 7
Insufficient Information 2 2
Break 2 2
Migration or Expulsion of Device 1 1
Nonstandard Device 1 1
Device Dislodged or Dislocated 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 9 9
Joint Dislocation 6 6
Pain 4 4
No Known Impact Or Consequence To Patient 2 2
Unspecified Tissue Injury 1 1
Patient Problem/Medical Problem 1 1
Bone Fracture(s) 1 1
Unspecified Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Wright Medical Technology, Inc. II Nov-25-2019
-
-