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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 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Break 136 136
Separation Failure 8 8
Peeled/Delaminated 5 5
Material Integrity Problem 5 5
Flaked 5 5
Component Incompatible 2 2
Patient-Device Incompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Unraveled Material 1 1
Mechanical Jam 1 1
Fracture 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Problem with Sterilization 1 1
Failure to Osseointegrate 1 1
Tear, Rip or Hole in Device Packaging 1 1
Detachment of Device or Device Component 1 1
Material Separation 1 1
Labelling, Instructions for Use or Training Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 114 114
Insufficient Information 30 30
No Consequences Or Impact To Patient 12 12
No Known Impact Or Consequence To Patient 9 9
No Patient Involvement 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hypersensitivity/Allergic reaction 1 1
Failure of Implant 1 1
No Information 1 1
Tooth Fracture 1 1
Foreign Body In Patient 1 1
Erythema 1 1
Device Embedded In Tissue or Plaque 1 1

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