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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
2014 10 10
2015 10 10
2016 37 37
2017 25 25
2018 38 38
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 148 160
Material Fragmentation 40 43
Detachment of Device or Device Component 38 38
Material Separation 23 25
Material Puncture/Hole 9 9
Fitting Problem 9 9
Loose or Intermittent Connection 6 6
Entrapment of Device 6 6
Product Quality Problem 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Disconnection 5 5
Fluid/Blood Leak 4 8
Fracture 4 4
Leak/Splash 4 4
Off-Label Use 4 6
Detachment Of Device Component 3 3
Bent 3 3
Material Twisted/Bent 3 3
Defective Device 3 3
Device Contamination with Body Fluid 3 7
Device Operates Differently Than Expected 3 3
Device Contamination with Chemical or Other Material 3 3
Material Integrity Problem 2 2
Difficult to Remove 2 2
Fail-Safe Problem 2 2
Connection Problem 2 2
Component Falling 2 2
Crack 1 1
Corroded 1 1
Unintended Movement 1 1
Fail-Safe Did Not Operate 1 1
Positioning Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Use of Device Problem 1 1
Device Dislodged or Dislocated 1 1
Mechanics Altered 1 1
Material Protrusion/Extrusion 1 1
Device Handling Problem 1 2
Loss of or Failure to Bond 1 1
Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Device Embedded In Tissue or Plaque 111 119
Foreign Body In Patient 64 78
Needle Stick/Puncture 46 51
No Consequences Or Impact To Patient 39 39
Exposure to Body Fluids 36 36
No Known Impact Or Consequence To Patient 18 18
No Clinical Signs, Symptoms or Conditions 9 9
No Code Available 8 8
Pain 8 8
Discomfort 7 7
No Information 5 5
Necrosis 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Patient Involvement 2 2
Unspecified Tissue Injury 2 2
Hemorrhage/Bleeding 2 2
Inflammation 1 1
Surgical procedure 1 1
Foreign body, removal of 1 1
Foreign Body Reaction 1 1
Burn(s) 1 1
Injury 1 1
Peripheral Nervous Injury 1 1
Pyogenic Infection 1 1
Ulcer 1 1

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