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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
2020 2 2
2021 1 1
2022 8 8
2023 14 14
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 17 17
Adverse Event Without Identified Device or Use Problem 15 15
Insufficient Information 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Tooth Fracture 11 11
Necrosis 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Pain 3 3
Unspecified Infection 2 2
Discomfort 2 2
Anaphylactic Shock 2 2
Sore Throat 2 2
Difficulty Chewing 1 1
Bone Fracture(s) 1 1
Abrasion 1 1
Pharyngitis 1 1
Burning Sensation 1 1
Dyspnea 1 1
Swelling/ Edema 1 1
Pressure Sores 1 1
Angioedema 1 1
Increased Sensitivity 1 1

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