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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device plugger, root canal, endodontic
Product CodeEKR
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2017 5 5
2018 45 45
2019 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Programming Issue 37 37
Break 7 7
Application Program Problem: Dose Calculation Error 5 5
Material Separation 3 3
Sparking 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Overheating of Device 1 1
Temperature Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 34 34
No Consequences Or Impact To Patient 8 8
No Information 4 4
Discomfort 2 2
Intraoperative Pain 2 2
Foreign Body In Patient 2 2
No Known Impact Or Consequence To Patient 1 1
Partial thickness (Second Degree) Burn 1 1
No Patient Involvement 1 1
Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ormco/Sybronendo II Jan-26-2018
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