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TPLC
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show TPLC since
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2020
2021
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2024
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Device
bracket, metal, orthodontic
Product Code
EJF
Regulation Number
872.5410
Device Class
1
MDR Year
MDR Reports
MDR Events
2017
8
8
2018
3
3
2019
1
1
2020
4
4
2021
1
1
2022
7
7
2023
6
6
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
9
9
Insufficient Information
3
3
Patient Device Interaction Problem
3
3
Improper or Incorrect Procedure or Method
3
3
Patient-Device Incompatibility
2
2
Biocompatibility
2
2
Sharp Edges
2
2
Use of Device Problem
2
2
Appropriate Term/Code Not Available
1
1
Detachment of Device or Device Component
1
1
Device Operates Differently Than Expected
1
1
Separation Failure
1
1
Detachment Of Device Component
1
1
Component Falling
1
1
Entrapment of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Tooth Fracture
12
12
Hypersensitivity/Allergic reaction
4
4
Abrasion
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Abdominal Pain
2
2
Shaking/Tremors
2
2
Sleep Dysfunction
2
2
No Code Available
2
2
Nausea
2
2
Blurred Vision
2
2
Hot Flashes/Flushes
2
2
Dizziness
2
2
Foreign Body Reaction
2
2
Headache
2
2
Depression
2
2
Irritability
2
2
Ulcer
1
1
Pressure Sores
1
1
Arthralgia
1
1
Visual Impairment
1
1
Vomiting
1
1
Diarrhea
1
1
Erythema
1
1
Fatigue
1
1
Syncope/Fainting
1
1
Speech Disorder
1
1
Metal Related Pathology
1
1
Skin Inflammation/ Irritation
1
1
Swelling/ Edema
1
1
Cognitive Changes
1
1
Foreign Body In Patient
1
1
Device Embedded In Tissue or Plaque
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ormco/Sybronendo
II
Jun-05-2020
2
Ortho Organizers, Inc.
II
Jun-30-2020
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