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 appliance, fixation, nail/blade/plate combination, single component
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeKTW
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
PAONAN BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 24 24
2019 11 11
2020 60 60
2021 25 25
2022 50 50
2023 30 30
2024 123 123
2025 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Break 154 154
Adverse Event Without Identified Device or Use Problem 89 89
Patient Device Interaction Problem 33 33
Failure to Cut 17 17
Device-Device Incompatibility 16 16
Material Twisted/Bent 9 9
Fracture 9 9
Migration 8 8
Positioning Failure 7 7
Material Deformation 7 7
Entrapment of Device 4 4
Physical Resistance/Sticking 4 4
Insufficient Information 3 3
Failure to Power Up 3 3
Fitting Problem 2 2
Defective Device 2 2
No Apparent Adverse Event 2 2
Device Slipped 1 1
Operating System Becomes Nonfunctional 1 1
Crack 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Positioning Problem 1 1
Use of Device Problem 1 1
Device Damaged by Another Device 1 1
Difficult or Delayed Positioning 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Device Dislodged or Dislocated 1 1
Appropriate Term/Code Not Available 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 75 75
Insufficient Information 55 55
No Clinical Signs, Symptoms or Conditions 49 49
Pain 32 32
Non-union Bone Fracture 28 28
Malunion of Bone 27 27
Foreign Body In Patient 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
No Code Available 18 18
Unspecified Infection 16 16
Hypersensitivity/Allergic reaction 14 14
Implant Pain 14 14
Bone Fracture(s) 7 7
Loss of Range of Motion 7 7
Impaired Healing 5 5
Necrosis 4 4
Unspecified Tissue Injury 4 4
No Consequences Or Impact To Patient 4 4
Arthritis 4 4
Not Applicable 2 2
No Known Impact Or Consequence To Patient 2 2
Nerve Damage 2 2
Osteolysis 2 2
Physical Asymmetry 2 2
Fracture, Arm 1 1
Joint Dislocation 1 1
Seizures 1 1
No Information 1 1
Spinal Column Injury 1 1
Post Operative Wound Infection 1 1
Irritation 1 1
Seroma 1 1
Swelling 1 1
Fall 1 1
Reaction 1 1
Limb Fracture 1 1
Swelling/ Edema 1 1
Erosion 1 1
Ambulation Difficulties 1 1

-
-