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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
2019 11 11
2020 60 60
2021 25 25
2022 50 50
2023 30 30
2024 123 123
2025 85 85

Device Problems MDRs with this Device Problem Events in those MDRs
Break 164 164
Adverse Event Without Identified Device or Use Problem 80 80
Patient Device Interaction Problem 48 48
Failure to Cut 20 20
Device-Device Incompatibility 15 15
Positioning Failure 11 11
Material Twisted/Bent 10 10
Migration 9 9
Entrapment of Device 7 7
Material Deformation 7 7
Fracture 7 7
Physical Resistance/Sticking 4 4
Fitting Problem 3 3
Insufficient Information 3 3
Failure to Power Up 3 3
No Apparent Adverse Event 3 3
Defective Device 2 2
Use of Device Problem 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
Device Damaged by Another Device 1 1
Difficult or Delayed Positioning 1 1
Detachment of Device or Device Component 1 1
Failure to Advance 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 73 73
No Clinical Signs, Symptoms or Conditions 73 73
Insufficient Information 57 57
Pain 47 47
Non-union Bone Fracture 41 41
Foreign Body In Patient 27 27
Malunion of Bone 27 27
Unspecified Infection 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Hypersensitivity/Allergic reaction 14 14
Implant Pain 14 14
No Code Available 11 11
Bone Fracture(s) 7 7
Loss of Range of Motion 6 6
Impaired Healing 4 4
Unspecified Tissue Injury 4 4
Arthritis 4 4
Necrosis 3 3
No Consequences Or Impact To Patient 3 3
Nerve Damage 2 2
Osteolysis 2 2
Physical Asymmetry 2 2
Joint Dislocation 1 1
Seizures 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
Ambulation Difficulties 1 1

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