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TPLC
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show TPLC since
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2019
2020
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2024
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Device
needle, dental
Product Code
DZM
Regulation Number
872.4730
Device Class
1
MDR Year
MDR Reports
MDR Events
2017
25
25
2018
38
38
2019
31
31
2020
16
16
2021
41
65
2022
35
35
2023
34
34
2024
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
105
117
Detachment of Device or Device Component
36
36
Material Fragmentation
36
39
Material Separation
15
17
Fitting Problem
9
9
Material Puncture/Hole
8
8
Loose or Intermittent Connection
6
6
Disconnection
5
5
Entrapment of Device
5
5
Product Quality Problem
5
5
Adverse Event Without Identified Device or Use Problem
4
4
Leak/Splash
4
4
Device Contamination with Chemical or Other Material
3
3
Detachment Of Device Component
3
3
Fluid/Blood Leak
3
7
Device Contamination with Body Fluid
3
7
Bent
3
3
Difficult to Remove
2
2
Material Twisted/Bent
2
2
Material Integrity Problem
2
2
Connection Problem
2
2
Fail-Safe Problem
1
1
Use of Device Problem
1
1
Device Dislodged or Dislocated
1
1
Loss of or Failure to Bond
1
1
Fail-Safe Did Not Operate
1
1
Defective Component
1
1
Sticking
1
1
Unintended Movement
1
1
Device Handling Problem
1
2
Material Protrusion/Extrusion
1
1
Off-Label Use
1
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Device Embedded In Tissue or Plaque
92
100
Foreign Body In Patient
59
73
Needle Stick/Puncture
40
45
Exposure to Body Fluids
31
31
No Consequences Or Impact To Patient
16
16
No Known Impact Or Consequence To Patient
9
9
No Clinical Signs, Symptoms or Conditions
9
9
Pain
7
7
No Code Available
5
5
No Information
4
4
Necrosis
3
3
Hemorrhage/Bleeding
2
2
Unspecified Tissue Injury
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Peripheral Nervous Injury
1
1
Pyogenic Infection
1
1
Inflammation
1
1
Foreign Body Reaction
1
1
Ulcer
1
1
Discomfort
1
1
Injury
1
1
No Patient Involvement
1
1
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