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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
Regulation Description Preformed tooth positioner.
Product CodeDYT
Regulation Number 872.5525
Device Class 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 8 8
2023 14 14
2024 13 13
2025 9 9
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 25 25
Appropriate Term/Code Not Available 15 15
Insufficient Information 3 3
Patient-Device Incompatibility 1 1
Therapeutic or Diagnostic Output Failure 1 1

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 5 5
Unspecified Infection 2 2
Difficulty Chewing 2 2
Discomfort 2 2
Anaphylactic Shock 2 2
Speech Disorder 1 1
Bone Fracture(s) 1 1
Abrasion 1 1
Pharyngitis 1 1
Localized Skin Lesion 1 1
Burning Sensation 1 1
Loss of Range of Motion 1 1
Dyspnea 1 1
Swelling/ Edema 1 1
Headache 1 1
Sore Throat 1 1
Tissue Breakdown 1 1
Increased Sensitivity 1 1

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