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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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Device
post, root canal
Product Code
ELR
Regulation Number
872.3810
Device Class
1
MDR Year
MDR Reports
MDR Events
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
28
28
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
15
15
Injury
6
6
No Known Impact Or Consequence To Patient
5
5
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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