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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device needle, dental
Regulation Description Dental injecting needle.
Product CodeDZM
Regulation Number 872.4730
Device Class 1

MDR Year MDR Reports MDR Events
2020 16 16
2021 41 65
2022 35 36
2023 34 34
2024 27 27
2025 11 11
2026 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 52 55
Break 36 48
Detachment of Device or Device Component 26 26
Material Separation 23 25
Material Puncture/Hole 14 14
Fitting Problem 9 9
Material Twisted/Bent 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Device Contamination with Body Fluid 3 7
Fluid/Blood Leak 3 7
Off-Label Use 3 5
Use of Device Problem 3 3
Fail-Safe Did Not Operate 3 3
Fracture 2 2
Device Handling Problem 2 3
Loose or Intermittent Connection 2 2
Device Dislodged or Dislocated 1 1
Product Quality Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Fail-Safe Problem 1 1
Connection Problem 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Device Embedded In Tissue or Plaque 65 73
Needle Stick/Puncture 54 60
Exposure to Body Fluids 43 43
Foreign Body In Patient 38 52
No Clinical Signs, Symptoms or Conditions 12 12
Discomfort 6 6
No Consequences Or Impact To Patient 6 6
Necrosis 5 5
Pain 5 5
Swelling/ Edema 3 3
Unspecified Tissue Injury 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Tachycardia 2 2
Bruise/Contusion 2 2
Hemorrhage/Blood Loss/Bleeding 2 2
Inflammation 1 1
Numbness 1 1
Ulcer 1 1
Difficulty Chewing 1 1
Foreign Body Reaction 1 1
No Information 1 1
Pyogenic Infection 1 1
No Known Impact Or Consequence To Patient 1 1
Scar Tissue 1 1
Peripheral Nervous Injury 1 1

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