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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device plugger, root canal, endodontic
Product CodeEKR
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2015 3 3
2016 5 5
2017 5 5
2018 45 45
2019 1 1
2020 1 1
2022 3 3
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Programming Issue 37 37
Break 17 17
Application Program Problem: Dose Calculation Error 5 5
Material Separation 5 5
Device Operates Differently Than Expected 2 2
Sparking 1 1
Overheating of Device 1 1
Insufficient Information 1 1
Temperature Problem 1 1
Detachment Of Device Component 1 1
Delamination 1 1
Detachment of Device or Device Component 1 1
Insufficient Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 34 34
No Consequences Or Impact To Patient 12 12
No Information 5 5
Insufficient Information 5 5
No Clinical Signs, Symptoms or Conditions 4 4
No Known Impact Or Consequence To Patient 3 3
Intraoperative Pain 2 2
Foreign Body In Patient 2 2
Discomfort 2 2
No Patient Involvement 2 2
Burn(s) 1 1
Pain 1 1
Partial thickness (Second Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ormco/Sybronendo II Jan-26-2018
2 Ormco/Sybronendo II Jun-14-2013
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