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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, diamond, dental
Product CodeDZP
Regulation Number 872.4535
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 6 6
2022 4 4
2023 5 5
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7 7
Material Twisted/Bent 7 7
Unintended Ejection 4 4
Unintended Movement 4 4
Detachment of Device or Device Component 3 3
Device Damaged by Another Device 3 3
Device Dislodged or Dislocated 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Temperature Problem 1 1
Vibration 1 1
Entrapment of Device 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Tooth Fracture 6 6
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 4 4
Foreign Body In Patient 3 3
Laceration(s) 3 3
Pain 2 2
Device Embedded In Tissue or Plaque 1 1

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