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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
2019
11
11
2020
60
60
2021
25
25
2022
50
50
2023
30
30
2024
38
38
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
72
72
Break
71
71
Patient Device Interaction Problem
16
16
Device-Device Incompatibility
15
15
Failure to Cut
11
11
Material Twisted/Bent
8
8
Fracture
7
7
Migration
6
6
Material Deformation
5
5
Failure to Power Up
3
3
Entrapment of Device
2
2
No Apparent Adverse Event
2
2
Insufficient Information
1
1
Appropriate Term/Code Not Available
1
1
Loss of or Failure to Bond
1
1
Crack
1
1
Difficult or Delayed Positioning
1
1
Device Slipped
1
1
Use of Device Problem
1
1
Operating System Becomes Nonfunctional
1
1
Positioning Problem
1
1
Detachment of Device or Device Component
1
1
Device Dislodged or Dislocated
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Failure of Implant
39
39
No Clinical Signs, Symptoms or Conditions
29
29
Insufficient Information
28
28
Pain
26
26
Non-union Bone Fracture
20
20
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
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
Foreign Body In Patient
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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