• 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 chisel, surgical, manual
Regulation Description Manual surgical instrument for general use.
Product CodeFZO
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2016 10 10
2017 15 15
2018 66 66
2019 25 25
2020 17 17
2021 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Break 109 109
Material Deformation 17 17
Fracture 9 9
Material Twisted/Bent 7 7
Material Fragmentation 5 5
Dull, Blunt 5 5
Adverse Event Without Identified Device or Use Problem 3 3
Corroded 2 2
Failure to Cut 2 2
Crack 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 1 1
Material Split, Cut or Torn 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
Difficult to Fold, Unfold or Collapse 1 1
Peeled/Delaminated 1 1
Defective Component 1 1
Device-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 49 49
No Consequences Or Impact To Patient 39 39
No Known Impact Or Consequence To Patient 22 22
No Clinical Signs, Symptoms or Conditions 20 20
No Information 11 11
Bone Fracture(s) 5 5
No Code Available 4 4
Device Embedded In Tissue or Plaque 1 1
Not Applicable 1 1
Abrasion 1 1
Insufficient Information 1 1

-
-