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TPLC
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show TPLC since
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2020
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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
2014
8
8
2015
9
9
2016
5
5
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
12
12
Insufficient Information
9
9
Device Operates Differently Than Expected
7
7
Improper or Incorrect Procedure or Method
5
5
Patient-Device Incompatibility
4
4
Patient Device Interaction Problem
3
3
Sharp Edges
2
2
Biocompatibility
2
2
Use of Device Problem
2
2
Entrapment of Device
1
1
Separation Failure
1
1
Therapeutic or Diagnostic Output Failure
1
1
Detachment of Device or Device Component
1
1
Component Falling
1
1
Detachment Of Device Component
1
1
Solder Joint Fracture
1
1
Appropriate Term/Code Not Available
1
1
Device Dislodged or Dislocated
1
1
Difficult to Remove
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Tooth Fracture
16
16
Hypersensitivity/Allergic reaction
4
4
Tissue Damage
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
No Code Available
3
3
Abrasion
3
3
Injury
3
3
Pressure Sores
3
3
Unspecified Infection
2
2
Abdominal Pain
2
2
Sleep Dysfunction
2
2
Nausea
2
2
Dizziness
2
2
Foreign Body Reaction
2
2
Foreign Body In Patient
2
2
Depression
2
2
Shaking/Tremors
2
2
Ulcer
2
2
Blurred Vision
2
2
Headache
2
2
Hot Flashes/Flushes
2
2
Irritability
2
2
Syncope/Fainting
1
1
Speech Disorder
1
1
Arthralgia
1
1
Metal Related Pathology
1
1
Fatigue
1
1
Skin Inflammation/ Irritation
1
1
Inflammation
1
1
Cognitive Changes
1
1
Alteration In Body Temperature
1
1
No Known Impact Or Consequence To Patient
1
1
Erythema
1
1
Vomiting
1
1
Diarrhea
1
1
Visual Impairment
1
1
Ulceration
1
1
Swelling/ Edema
1
1
Loss of consciousness
1
1
Device Embedded In Tissue or Plaque
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ormco Corporation
III
Mar-01-2012
2
Ormco/Sybronendo
II
Jun-05-2020
3
Ormco/Sybronendo
II
Apr-02-2014
4
Ormco/Sybronendo
III
Oct-23-2012
5
Ortho Organizers, Inc.
II
Jun-30-2020
6
Ultradent Products, Inc.
III
Feb-22-2013
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