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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
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 62 62

Device Problems MDRs with this Device Problem Events in those MDRs
Break 79 79
Adverse Event Without Identified Device or Use Problem 73 73
Failure to Cut 16 16
Patient Device Interaction Problem 16 16
Device-Device Incompatibility 15 15
Material Twisted/Bent 8 8
Migration 7 7
Material Deformation 7 7
Positioning Failure 7 7
Fracture 7 7
Failure to Power Up 3 3
Entrapment of Device 3 3
Defective Device 2 2
No Apparent Adverse Event 2 2
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Loss of or Failure to Bond 1 1
Operating System Becomes Nonfunctional 1 1
Positioning Problem 1 1
Crack 1 1
Difficult or Delayed Positioning 1 1
Device Slipped 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 41 41
Insufficient Information 39 39
Failure of Implant 39 39
Pain 26 26
Non-union Bone Fracture 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Hypersensitivity/Allergic reaction 14 14
No Code Available 11 11
Malunion of Bone 9 9
Unspecified Infection 9 9
Bone Fracture(s) 7 7
Loss of Range of Motion 6 6
Arthritis 4 4
Unspecified Tissue Injury 4 4
Impaired Healing 4 4
Foreign Body In Patient 4 4
Necrosis 3 3
No Consequences Or Impact To Patient 3 3
Osteolysis 2 2
Nerve Damage 2 2
Physical Asymmetry 2 2
Swelling/ Edema 1 1
Reaction 1 1
Post Operative Wound Infection 1 1
Ambulation Difficulties 1 1
Implant Pain 1 1
Limb Fracture 1 1
Irritation 1 1
Fall 1 1
Joint Dislocation 1 1
Seizures 1 1
Seroma 1 1
Swelling 1 1

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