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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2019 31 31
2020 16 16
2021 41 65
2022 35 35
2023 34 34
2024 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Break 60 72
Material Fragmentation 40 43
Detachment of Device or Device Component 29 29
Material Separation 20 22
Fitting Problem 9 9
Material Puncture/Hole 9 9
Loose or Intermittent Connection 6 6
Adverse Event Without Identified Device or Use Problem 4 4
Device Contamination with Body Fluid 3 7
Fluid/Blood Leak 3 7
Device Contamination with Chemical or Other Material 3 3
Product Quality Problem 3 3
Material Twisted/Bent 3 3
Entrapment of Device 2 2
Fracture 2 2
Disconnection 2 2
Material Integrity Problem 2 2
Fail-Safe Problem 2 2
Off-Label Use 1 3
Device Handling Problem 1 2
Device Dislodged or Dislocated 1 1
Connection Problem 1 1
Fail-Safe Did Not Operate 1 1
Unintended Movement 1 1
Defective Component 1 1
Material Protrusion/Extrusion 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Device Embedded In Tissue or Plaque 58 66
Foreign Body In Patient 49 63
Needle Stick/Puncture 45 50
Exposure to Body Fluids 36 36
No Consequences Or Impact To Patient 11 11
No Clinical Signs, Symptoms or Conditions 9 9
Pain 5 5
No Information 4 4
Discomfort 4 4
Necrosis 3 3
No Known Impact Or Consequence To Patient 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Code Available 2 2
Unspecified Tissue Injury 2 2
Hemorrhage/Bleeding 2 2
Inflammation 1 1
Foreign Body Reaction 1 1
No Patient Involvement 1 1
Pyogenic Infection 1 1
Peripheral Nervous Injury 1 1
Ulcer 1 1

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