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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
2017 17 17
2018 9 9
2019 12 12
2020 15 15
2021 21 21
2022 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 67 67
Flaked 5 5
Peeled/Delaminated 5 5
Material Integrity Problem 5 5
Component Incompatible 2 2
Detachment of Device or Device Component 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Material Separation 1 1
Unraveled Material 1 1
Tear, Rip or Hole in Device Packaging 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 31 31
No Clinical Signs, Symptoms or Conditions 30 30
No Known Impact Or Consequence To Patient 18 18
Insufficient Information 8 8
No Information 5 5
No Patient Involvement 3 3
Foreign Body In Patient 1 1
Tooth Fracture 1 1
No Code Available 1 1
Device Embedded In Tissue or Plaque 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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