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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 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 76 77

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1845 1846
Difficult to Remove 70 70
Entrapment of Device 58 58
Material Separation 55 55
Detachment of Device or Device Component 19 19
Material Fragmentation 5 5
Fracture 5 5
Adverse Event Without Identified Device or Use Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Nonstandard Device 2 2
Defective Device 1 1
Separation Problem 1 1
Display or Visual Feedback Problem 1 1
Unintended Compatibility 1 1
Loose or Intermittent Connection 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Loss of Osseointegration 1 1
Fitting Problem 1 1
Use of Device Problem 1 1
Appropriate Term/Code Not Available 1 1
Patient-Device Incompatibility 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Device Embedded In Tissue or Plaque 1272 1273
Insufficient Information 434 434
No Known Impact Or Consequence To Patient 284 284
No Clinical Signs, Symptoms or Conditions 233 233
Foreign Body In Patient 182 182
No Information 166 166
No Consequences Or Impact To Patient 36 36
Injury 26 26
Apicectomy 9 9
No Code Available 7 7
Pain 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Sensitivity of Teeth 4 4
Tooth Fracture 4 4
Abrasion 3 3
Unspecified Tissue Injury 3 3
Swelling/ Edema 2 2
Failure of Implant 2 2
Inflammation 1 1
Sinus Perforation 1 1
Needle Stick/Puncture 1 1

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