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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
2018 9 9
2019 12 12
2020 15 15
2021 21 21
2022 26 26
2023 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Break 102 102
Flaked 5 5
Material Integrity Problem 5 5
Peeled/Delaminated 5 5
Component Incompatible 2 2
Labelling, Instructions for Use or Training Problem 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Bent 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 73 73
Insufficient Information 20 20
No Consequences Or Impact To Patient 20 20
No Known Impact Or Consequence To Patient 13 13
No Information 2 2
No Patient Involvement 2 2
Foreign Body In Patient 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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