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TPLC
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Device
appliance, fixation, nail/blade/plate combination, single component
Product Code
KTW
Regulation Number
888.3030
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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