• 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 tissue graft of 6mm and greater
Product CodeLXA
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
1 0 1 4 3 0

MDR Year MDR Reports MDR Events
2020 3 3
2021 6 6
2022 8 8
2023 12 12
2024 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 18 18
Insufficient Information 12 12
Material Puncture/Hole 11 11
Contamination 2 2
Material Rupture 2 2
Obstruction of Flow 2 2
Fluid/Blood Leak 1 1
Structural Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
Insufficient Information 7 7
Pseudoaneurysm 5 5
Thrombosis/Thrombus 5 5
Seroma 5 5
Unspecified Infection 3 3
Hematoma 3 3
Bacterial Infection 3 3
Hemorrhage/Bleeding 3 3
No Known Impact Or Consequence To Patient 2 2
Post Operative Wound Infection 2 2
Aneurysm 2 2
Stenosis 1 1
Rupture 1 1
Vascular Dissection 1 1

-
-