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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
2021 41 65
2022 35 36
2023 34 34
2024 27 27
2025 11 11
2026 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 48 51
Break 30 42
Detachment of Device or Device Component 26 26
Material Separation 24 26
Material Puncture/Hole 14 14
Fitting Problem 7 7
Loose or Intermittent Connection 6 7
Material Twisted/Bent 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Off-Label Use 3 5
Device Contamination with Body Fluid 3 7
Use of Device Problem 3 3
Product Quality Problem 3 3
Fluid/Blood Leak 3 7
Entrapment of Device 2 2
Fail-Safe Did Not Operate 2 2
Fail-Safe Problem 2 2
Device Handling Problem 2 3
Fracture 2 2
Defective Component 1 1
Material Protrusion/Extrusion 1 1
Device Dislodged or Dislocated 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Device Embedded In Tissue or Plaque 60 68
Needle Stick/Puncture 53 59
Exposure to Body Fluids 42 42
Foreign Body In Patient 31 45
No Clinical Signs, Symptoms or Conditions 12 12
Necrosis 5 5
Discomfort 5 5
Pain 3 3
Swelling/ Edema 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Tachycardia 2 2
Unspecified Tissue Injury 2 2
Hemorrhage/Bleeding 2 2
Bruise/Contusion 2 2
Difficulty Chewing 1 1
Inflammation 1 1
Numbness 1 1
Scar Tissue 1 1
Peripheral Nervous Injury 1 1
Ulcer 1 1

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