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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bracket, metal, orthodontic
Product CodeEJF
Regulation Number 872.5410
Device Class 1

MDR Year MDR Reports MDR Events
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 4 4
Patient Device Interaction Problem 3 3
Insufficient Information 3 3
Biocompatibility 2 2
Sharp Edges 2 2
Use of Device Problem 2 2
Appropriate Term/Code Not Available 1 1
Patient-Device Incompatibility 1 1
Entrapment of Device 1 1
Detachment of Device or Device Component 1 1
Separation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Tooth Fracture 6 6
Abrasion 3 3
Hypersensitivity/Allergic reaction 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Abdominal Pain 2 2
Depression 2 2
Irritability 2 2
Foreign Body Reaction 2 2
Headache 2 2
Hot Flashes/Flushes 2 2
Dizziness 2 2
Nausea 2 2
Blurred Vision 2 2
Shaking/Tremors 2 2
Sleep Dysfunction 2 2
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1
Syncope/Fainting 1 1
Speech Disorder 1 1
Metal Related Pathology 1 1
Skin Inflammation/ Irritation 1 1
Swelling/ Edema 1 1
Visual Impairment 1 1
Vomiting 1 1
Diarrhea 1 1
Erythema 1 1
Fatigue 1 1
Arthralgia 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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