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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
Product CodeDZN
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2019 12 12
2020 15 15
2021 21 21
2022 26 26
2023 38 38
2024 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Break 112 112
Flaked 5 5
Peeled/Delaminated 5 5
Material Integrity Problem 5 5
Separation Failure 2 2
Component Incompatible 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
Patient-Device Incompatibility 1 1
Detachment of Device or Device Component 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 88 88
Insufficient Information 24 24
No Consequences Or Impact To Patient 12 12
No Known Impact Or Consequence To Patient 9 9
No Patient Involvement 2 2
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Tooth Fracture 1 1
Erythema 1 1
Hypersensitivity/Allergic reaction 1 1
Failure of Implant 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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