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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device bracket, metal, orthodontic
Product CodeEJF
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
Biocompatibility 2 2
Use of Device Problem 2 2
Sharp Edges 2 2
Solder Joint Fracture 1 1
Detachment of Device or Device Component 1 1
Difficult to Remove 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Entrapment of Device 1 1
Separation Failure 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Dislodged or Dislocated 1 1
Appropriate Term/Code Not Available 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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