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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device syringe, periodontic, endodontic, irrigating
Product CodeEIC
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
Sinus Perforation 2 2
Pain 2 2
Perforation 2 2
Tingling 1 1
No Patient Involvement 1 1
Necrosis 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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