• 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 dispenser, cement
Product CodeKIH
Regulation Number 888.4200
Device Class 1

MDR Year MDR Reports MDR Events
2019 29 29
2020 23 23
2021 30 30
2022 26 26
2023 30 30
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Break 50 50
Mechanical Jam 19 19
Leak/Splash 17 17
Failure to Eject 11 11
Chemical Problem 9 9
Appropriate Term/Code Not Available 8 8
Device-Device Incompatibility 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Mechanics Altered 6 6
Defective Device 5 5
Loss of or Failure to Bond 4 4
Entrapment of Device 3 3
Defective Component 3 3
Device Contaminated During Manufacture or Shipping 2 2
Material Deformation 2 2
Connection Problem 2 2
Device Slipped 1 1
Mechanical Problem 1 1
Migration or Expulsion of Device 1 1
Off-Label Use 1 1
Malposition of Device 1 1
Output Problem 1 1
Pumping Problem 1 1
Expiration Date Error 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Difficult to Remove 1 1
Material Twisted/Bent 1 1
Packaging Problem 1 1
Failure to Prime 1 1
Material Separation 1 1
Explosion 1 1
Fracture 1 1
Naturally Worn 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 68 68
No Consequences Or Impact To Patient 35 35
Insufficient Information 9 9
Pain 7 7
Extravasation 7 7
No Known Impact Or Consequence To Patient 5 5
No Code Available 4 4
Foreign Body In Patient 4 4
Device Embedded In Tissue or Plaque 3 3
Necrosis 2 2
Abrasion 2 2
No Patient Involvement 2 2
Non-union Bone Fracture 2 2
Neuropathy 1 1
Weight Changes 1 1
Failure of Implant 1 1
Adhesion(s) 1 1
Inflammation 1 1
Synovitis 1 1
Edema 1 1
Hair Loss 1 1
Dysphagia/ Odynophagia 1 1
Joint Laxity 1 1
Paraplegia 1 1
Spinal Cord Injury 1 1
Nervous System Injury 1 1
Vertebral Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer Biomet, Inc. II Apr-01-2019
-
-