• 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 replacement, ossicular prosthesis, total
Product CodeETA
Regulation Number 874.3495
Device Class 2

MDR Year MDR Reports MDR Events
2019 9 9
2020 1 1
2022 4 4
2023 5 5
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 12 12
Material Separation 4 4
Adverse Event Without Identified Device or Use Problem 2 2
Use of Device Problem 1 1
Detachment of Device or Device Component 1 1
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 7 7
No Clinical Signs, Symptoms or Conditions 7 7
Failure of Implant 3 3
Hearing Impairment 2 2
Hearing Loss 1 1
Perforation 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Unspecified Ear or Labyrinth Problem 1 1
Implant Pain 1 1

-
-