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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device post, root canal
Product CodeELR
Regulation Number 872.3810
Device Class 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 5 5
2019 20 20
2020 2 2
2021 3 3
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 29 29
Entrapment of Device 1 1
Fracture 1 1
Difficult to Remove 1 1
Material Too Rigid or Stiff 1 1
Improper or Incorrect Procedure or Method 1 1
Dull, Blunt 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1
Detachment of Device or Device Component 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Material Too Soft/Flexible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 16 16
Injury 6 6
No Known Impact Or Consequence To Patient 6 6
No Clinical Signs, Symptoms or Conditions 5 5
Device Embedded In Tissue or Plaque 3 3
No Code Available 3 3
Insufficient Information 2 2
No Information 2 2
Tooth Fracture 1 1
No Patient Involvement 1 1
Hypersensitivity/Allergic reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Coltene Whaledent Inc II Nov-02-2018
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