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TPLC
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show TPLC since
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Device
syringe, periodontic, endodontic, irrigating
Product Code
EIC
Regulation Number
872.4565
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
2
2
2015
3
3
2016
8
8
2017
35
35
2018
19
19
2019
146
146
2020
35
35
2021
76
76
2022
11
11
2023
19
19
2024
12
12
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
354
354
Detachment Of Device Component
4
4
Inadequacy of Device Shape and/or Size
3
3
Entrapment of Device
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Peeled/Delaminated
2
2
Insufficient Information
1
1
Material Fragmentation
1
1
Inaccurate Synchronization
1
1
Defective Component
1
1
Overfill
1
1
Device Operates Differently Than Expected
1
1
Component Falling
1
1
Crack
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
169
169
No Known Impact Or Consequence To Patient
149
149
No Clinical Signs, Symptoms or Conditions
110
110
No Information
54
54
Insufficient Information
52
52
Device Embedded In Tissue or Plaque
21
21
Foreign Body In Patient
12
12
Pain
2
2
Perforation
2
2
Sinus Perforation
2
2
Tingling
1
1
Necrosis
1
1
Unspecified Tissue Injury
1
1
No Patient Involvement
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Stradis Medical, LLC dba Stradis Healthcare
II
Dec-14-2022
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