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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device maintainer, space preformed, orthodontic
Product CodeDYT
Regulation Number 872.5525
Device Class 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 3 3
2018 5 5
2019 8 8
2020 2 2
2021 1 1
2022 8 8
2023 14 14
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 27 27
Adverse Event Without Identified Device or Use Problem 14 14
Patient-Device Incompatibility 3 3
Inaccurate Dispensing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Tooth Fracture 7 7
No Code Available 7 7
Necrosis 6 6
Pain 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Burning Sensation 3 3
Swelling 3 3
Chest Pain 3 3
Fatigue 3 3
Anaphylactic Shock 2 2
Asthma 2 2
Inflammation 2 2
Discomfort 2 2
Sore Throat 2 2
Skin Inflammation 1 1
Blood Loss 1 1
Dizziness 1 1
Ulcer 1 1
Pressure Sores 1 1
Angioedema 1 1
Swelling/ Edema 1 1
Irritation 1 1
Nausea 1 1
Vomiting 1 1
Rash 1 1
Red Eye(s) 1 1
Erythema 1 1
Bone Fracture(s) 1 1
Hair Loss 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1

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