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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instruments, dental hand
Regulation Description Dental hand instrument.
Product CodeDZN
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2020 15 15
2021 21 21
2022 26 26
2023 38 38
2024 69 69
2025 31 31
2026 38 38

Device Problems MDRs with this Device Problem Events in those MDRs
Break 211 211
Separation Failure 10 10
Material Deformation 6 6
Material Integrity Problem 2 2
Component Incompatible 2 2
Fracture 2 2
Labelling, Instructions for Use or Training Problem 1 1
Material Separation 1 1
Problem with Sterilization 1 1
Unraveled Material 1 1
Failure to Osseointegrate 1 1
Tear, Rip or Hole in Device Packaging 1 1
Mechanical Jam 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Patient Device Interaction Problem 1 1
Patient-Device Incompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 183 183
Insufficient Information 48 48
No Consequences Or Impact To Patient 6 6
No Known Impact Or Consequence To Patient 3 3
Failure of Implant 2 2
No Patient Involvement 2 2
Device Embedded In Tissue or Plaque 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hypersensitivity/Allergic reaction 1 1
Intraoperative Pain 1 1
Tooth Fracture 1 1
Foreign Body In Patient 1 1
Erythema 1 1

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