Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 elevator, surgical, dental
Product CodeEMJ
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2019 73 73
2020 39 39
2021 65 65
2022 46 46
2023 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 243 243
Break 17 17
Crack 8 8
Material Fragmentation 4 4
Material Separation 1 1
Detachment of Device or Device Component 1 1
Material Twisted/Bent 1 1
Degraded 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 134 134
No Known Impact Or Consequence To Patient 60 60
No Consequences Or Impact To Patient 54 54
No Information 8 8
No Patient Involvement 6 6
Foreign Body In Patient 5 5
Insufficient Information 2 2
Device Embedded In Tissue or Plaque 1 1
Injury 1 1
Needle Stick/Puncture 1 1
Laceration(s) 1 1
Pain 1 1

-
-