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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device drill, dental, intraoral
Product CodeDZA
Regulation Number 872.4130
Device Class 1

MDR Year MDR Reports MDR Events
2020 9 9
2021 8 8
2022 1 1
2023 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 11 11
Material Separation 3 3
Fracture 3 3
Mechanical Problem 2 2
Separation Problem 1 1
Entrapment of Device 1 1
Vibration 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Naturally Worn 1 1
Overheating of Device 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
Insufficient Information 4 4
No Known Impact Or Consequence To Patient 3 3
No Information 2 2
Device Embedded In Tissue or Plaque 2 2
Blister 1 1
Skin Discoloration 1 1
Burn(s) 1 1
Laceration(s) 1 1
Partial thickness (Second Degree) Burn 1 1

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