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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wire, orthodontic
Product CodeDZC
Regulation Number 872.5410
Device Class 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 1 1
2021 3 3
2022 7 7
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 6 6
Break 4 4
Inadequacy of Device Shape and/or Size 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 1 1
Migration 1 1
Device Slipped 1 1
Biocompatibility 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Device Embedded In Tissue or Plaque 4 4
Hypersensitivity/Allergic reaction 3 3
Foreign Body In Patient 3 3
No Known Impact Or Consequence To Patient 1 1
Inflammation 1 1
Sensitivity of Teeth 1 1
No Information 1 1
No Code Available 1 1
Glossitis 1 1
Skin Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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