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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
2018 24 24
2019 11 11
2020 60 60
2021 25 25
2022 50 50
2023 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Break 72 72
Adverse Event Without Identified Device or Use Problem 64 64
Device-Device Incompatibility 16 16
Material Twisted/Bent 9 9
Failure to Cut 8 8
Fracture 8 8
Migration 6 6
Material Deformation 5 5
Failure to Power Up 3 3
Fitting Problem 2 2
Patient Device Interaction Problem 2 2
No Apparent Adverse Event 2 2
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Operating System Becomes Nonfunctional 1 1
Positioning Problem 1 1
Loss of or Failure to Bond 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Device Dislodged or Dislocated 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Slipped 1 1
Use of Device Problem 1 1
Crack 1 1
Difficult or Delayed Positioning 1 1
Entrapment of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 39 39
Pain 27 27
No Clinical Signs, Symptoms or Conditions 27 27
Insufficient Information 25 25
Non-union Bone Fracture 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
No Code Available 18 18
Unspecified Infection 12 12
Loss of Range of Motion 7 7
Bone Fracture(s) 7 7
Impaired Healing 5 5
No Consequences Or Impact To Patient 4 4
Unspecified Tissue Injury 4 4
Malunion of Bone 3 3
Osteolysis 2 2
No Known Impact Or Consequence To Patient 2 2
Not Applicable 2 2
Physical Asymmetry 2 2
Necrosis 2 2
Fracture, Arm 1 1
Reaction 1 1
Post Operative Wound Infection 1 1
Ambulation Difficulties 1 1
Seizures 1 1
Seroma 1 1
Spinal Column Injury 1 1
Swelling 1 1
Irritation 1 1
Erosion 1 1
Fall 1 1
Swelling/ Edema 1 1
No Information 1 1
Joint Dislocation 1 1
Limb Fracture 1 1

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