• 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 rod, fixation, intramedullary and accessories, in-vivo cured, light-activated
Regulation Description In vivo cured intramedullary fixation rod.
Definition Is a device intended to be implanted that consists of a polymeric balloon that is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures. The balloon is infused with a liquid monomer that causes the balloon to fill the medullary canal of the fractured bone. The device is then exposed to a light source that polymerizes the light-activated monomer within the balloon creating a hardened rigid structure.
Product CodeQAD
Regulation Number 888.3023
Device Class 2

MDR Year MDR Reports MDR Events
2018 3 3
2019 8 8
2020 7 7
2021 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 11 11
Break 3 3
Off-Label Use 2 2
Device Damaged by Another Device 2 2
Material Too Soft/Flexible 2 2
Loss of Osseointegration 2 2
Material Integrity Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Shipping Damage or Problem 1 1
Activation, Positioning or SeparationProblem 1 1
Loss of or Failure to Bond 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 16 16
Fracture, Arm 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Device Embedded In Tissue or Plaque 2 2
Bone Fracture(s) 1 1
Impaired Healing 1 1
Patient Problem/Medical Problem 1 1
No Known Impact Or Consequence To Patient 1 1

-
-