• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 103 104

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1871 1872
Difficult to Remove 70 70
Entrapment of Device 58 58
Material Separation 55 55
Detachment of Device or Device Component 20 20
Fracture 5 5
Material Fragmentation 5 5
Adverse Event Without Identified Device or Use Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Nonstandard Device 2 2
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Separation Problem 1 1
Unintended Compatibility 1 1
Material Integrity Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Display or Visual Feedback Problem 1 1
Loose or Intermittent Connection 1 1
Use of Device Problem 1 1
Fitting Problem 1 1
Loss of Osseointegration 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Device Embedded In Tissue or Plaque 1291 1292
Insufficient Information 441 441
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
Laceration(s) 1 1
Needle Stick/Puncture 1 1
Sinus Perforation 1 1

-
-