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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device file, pulp canal, endodontic
Product CodeEKS
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2019 468 468
2020 421 421
2021 342 342
2022 291 291
2023 264 264
2024 272 273

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2035 2036
Difficult to Remove 70 70
Entrapment of Device 58 58
Material Separation 55 55
Detachment of Device or Device Component 20 20
Material Fragmentation 6 6
Fracture 6 6
Therapeutic or Diagnostic Output Failure 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Nonstandard Device 2 2
Fitting Problem 1 1
Separation Problem 1 1
Patient-Device Incompatibility 1 1
Unintended Movement 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Patient Device Interaction Problem 1 1
Use of Device Problem 1 1
Material Twisted/Bent 1 1
Unintended Compatibility 1 1
Use of Incorrect Control/Treatment Settings 1 1
Device Handling Problem 1 1
Appropriate Term/Code Not Available 1 1
Display or Visual Feedback Problem 1 1
Loose or Intermittent Connection 1 1
Dull, Blunt 1 1
Loss of Osseointegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Device Embedded In Tissue or Plaque 1412 1413
Insufficient Information 470 470
No Known Impact Or Consequence To Patient 284 284
No Clinical Signs, Symptoms or Conditions 251 251
Foreign Body In Patient 183 183
No Information 166 166
No Consequences Or Impact To Patient 36 36
Injury 26 26
Apicectomy 9 9
Pain 8 8
No Code Available 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Tooth Fracture 4 4
Sensitivity of Teeth 4 4
Abrasion 3 3
Needle Stick/Puncture 3 3
Unspecified Tissue Injury 3 3
Failure of Implant 2 2
Laceration(s) 2 2
Swelling/ Edema 2 2
Unspecified Infection 1 1
Sinus Perforation 1 1
Inflammation 1 1
Discomfort 1 1
Hemorrhage/Bleeding 1 1
Tissue Breakdown 1 1

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