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 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


Premarket Reviews
ManufacturerDecision
ILLUMINOSS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 8 8
2022 25 25
2023 47 47
2024 34 34
2025 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 27 27
Adverse Event Without Identified Device or Use Problem 20 20
Material Separation 20 20
Fracture 20 20
Gel Leak 20 20
Material Too Soft/Flexible 11 11
Gas/Air Leak 7 7
Break 5 5
Material Integrity Problem 4 4
Material Twisted/Bent 4 4
Optical Problem 4 4
Defective Device 3 3
Manufacturing, Packaging or Shipping Problem 3 3
No Apparent Adverse Event 3 3
Burst Container or Vessel 1 1
Mechanical Problem 1 1
Off-Label Use 1 1
Malposition of Device 1 1
Lack of Effect 1 1
Power Problem 1 1
Electrical /Electronic Property Problem 1 1
Deformation Due to Compressive Stress 1 1
Loss of or Failure to Bond 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 59 59
Insufficient Information 16 16
Bone Fracture(s) 15 15
Implant Pain 12 12
Non-union Bone Fracture 10 10
Cardiac Arrest 5 5
Pain 5 5
Foreign Body In Patient 4 4
Low Blood Pressure/ Hypotension 4 4
Failure of Implant 3 3
Embolism/Embolus 3 3
Post Operative Wound Infection 2 2
Swelling/ Edema 2 2
High Blood Pressure/ Hypertension 1 1
Impaired Healing 1 1
Hypersensitivity/Allergic reaction 1 1
Respiratory Arrest 1 1
Inflammation 1 1
Purulent Discharge 1 1
Fever 1 1
Thrombosis/Thrombus 1 1
Osteomyelitis 1 1
Dyspnea 1 1
Abscess 1 1
Fluid Discharge 1 1
Limb Fracture 1 1
Bacterial Infection 1 1
Low Oxygen Saturation 1 1
Pulmonary Embolism 1 1

-
-