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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device curette, periodontic
Product CodeEMS
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2015 3 3
2016 3 3
2017 2 2
2018 2 2
2019 5 5
2020 1 1
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 10 10
Break 6 6
Inadequate Service 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7 7
Foreign Body In Patient 5 5
Device Embedded In Tissue or Plaque 3 3
Insufficient Information 1 1
Laceration(s) 1 1
Myocardial Infarction 1 1
Blood Loss 1 1

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