• 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 bone mill
Product CodeLYS
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 46 46
2019 54 54
2020 66 66
2021 173 173
2022 125 125

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 302 302
Dull, Blunt 136 136
Naturally Worn 22 22
Material Deformation 13 13
Material Twisted/Bent 10 10
Device-Device Incompatibility 8 8
Break 7 7
Adverse Event Without Identified Device or Use Problem 5 5
Appropriate Term/Code Not Available 3 3
Contamination /Decontamination Problem 3 3
Loose or Intermittent Connection 2 2
Mechanical Problem 2 2
Device Abrasion From Instrument Or Another Object 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Material Integrity Problem 1 1
Scratched Material 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 289 289
No Consequences Or Impact To Patient 148 148
Insufficient Information 19 19
No Code Available 12 12
Not Applicable 8 8
Nerve Damage 1 1
No Known Impact Or Consequence To Patient 1 1
Missing Value Reason 1 1

-
-