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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

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 48 51
Break 40 52
Detachment of Device or Device Component 26 26
Material Separation 23 25
Material Puncture/Hole 11 11
Fitting Problem 9 9
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
Unintended Movement 1 1
Defective Component 1 1
Device Contamination with Chemical or Other Material 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 61 69
Needle Stick/Puncture 50 56
Exposure to Body Fluids 39 39
Foreign Body In Patient 37 51
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
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
No Information 1 1
Inflammation 1 1
Foreign Body Reaction 1 1
No Known Impact Or Consequence To Patient 1 1
Numbness 1 1
Scar Tissue 1 1
Peripheral Nervous Injury 1 1
Pyogenic Infection 1 1
Ulcer 1 1

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