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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device rod, fixation, intramedullary and accessories, in-vivo cured, light-activated
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
ILLMINOSS MEDICAL, INC.
  GRANTED 1
ILLUMINOSS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6

MDR Year MDR Reports MDR Events
2018 4 4
2019 8 8
2020 7 7
2021 8 8
2022 25 25
2023 47 47
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 25 25
Gel Leak 14 14
Material Separation 14 14
Adverse Event Without Identified Device or Use Problem 12 12
Material Too Soft/Flexible 9 9
Gas/Air Leak 6 6
Defective Device 3 3
Break 3 3
Off-Label Use 2 2
Loss of Osseointegration 2 2
No Apparent Adverse Event 2 2
Device Damaged by Another Device 2 2
Material Twisted/Bent 2 2
Insufficient Information 1 1
Lack of Effect 1 1
Loss of or Failure to Bond 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Malposition of Device 1 1
Deformation Due to Compressive Stress 1 1
Activation, Positioning or Separation Problem 1 1
Shipping Damage or Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Electrical /Electronic Property Problem 1 1
Fluid/Blood Leak 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 42 42
Failure of Implant 16 16
Bone Fracture(s) 9 9
Non-union Bone Fracture 8 8
Implant Pain 5 5
Cardiac Arrest 4 4
Pain 3 3
Fracture, Arm 3 3
Device Embedded In Tissue or Plaque 3 3
Swelling/ Edema 2 2
Insufficient Information 2 2
Low Blood Pressure/ Hypotension 2 2
Bacterial Infection 1 1
Inflammation 1 1
Purulent Discharge 1 1
Fever 1 1
High Blood Pressure/ Hypertension 1 1
Impaired Healing 1 1
Post Operative Wound Infection 1 1
Low Oxygen Saturation 1 1
Fluid Discharge 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
No Known Impact Or Consequence To Patient 1 1
Embolism/Embolus 1 1
Respiratory Arrest 1 1

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