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 mixer, cement, for clinical use
Product CodeJDZ
Regulation Number 888.4210
Device Class 1

MDR Year MDR Reports MDR Events
2019 33 39
2020 167 200
2021 58 71
2022 46 50
2023 65 330
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contaminated During Manufacture or Shipping 134 134
Packaging Problem 73 73
Detachment of Device or Device Component 61 335
Delivered as Unsterile Product 33 43
Material Disintegration 18 55
Unsealed Device Packaging 14 14
Break 6 6
Insufficient Information 6 6
Defective Device 4 4
Crack 3 3
Fracture 3 3
Difficult to Open or Remove Packaging Material 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Discolored 2 2
Tear, Rip or Hole in Device Packaging 2 2
Patient Device Interaction Problem 2 2
Migration 2 2
Mechanical Jam 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Output Problem 1 1
Pressure Problem 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Material Twisted/Bent 1 1
Device Dislodged or Dislocated 1 1
Improper Flow or Infusion 1 1
Material Fragmentation 1 1
Flaked 1 1
Unintended Power Up 1 1
Contamination 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Device Difficult to Setup or Prepare 1 1
Decrease in Pressure 1 1
Inadequacy of Device Shape and/or Size 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 182 494
No Patient Involvement 144 170
No Known Impact Or Consequence To Patient 29 44
No Consequences Or Impact To Patient 23 42
Insufficient Information 6 255
No Information 4 4
Joint Disorder 1 1
Not Applicable 1 1
Death 1 1
Extravasation 1 1
Hearing Loss 1 1
Failure of Implant 1 1
Unspecified Infection 1 1

-
-