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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 50 50
Mechanical Jam 18 18
Leak/Splash 16 16
Failure to Eject 11 11
Chemical Problem 9 9
Appropriate Term/Code Not Available 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Device-Device Incompatibility 6 6
Mechanics Altered 6 6
Defective Device 5 5
Loss of or Failure to Bond 4 4
Defective Component 3 3
Entrapment of Device 3 3
Device Contaminated During Manufacture or Shipping 2 2
Material Deformation 2 2
Connection Problem 2 2
Explosion 1 1
Therapeutic or Diagnostic Output Failure 1 1
Improper or Incorrect Procedure or Method 1 1
Expiration Date Error 1 1
Failure to Prime 1 1
Fracture 1 1
Migration or Expulsion of Device 1 1
Material Twisted/Bent 1 1
Difficult to Remove 1 1
Material Separation 1 1
Pumping Problem 1 1
Off-Label Use 1 1
Malposition of Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Slipped 1 1
Packaging Problem 1 1
Naturally Worn 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 65 65
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
Foreign Body In Patient 4 4
No Code Available 4 4
Device Embedded In Tissue or Plaque 3 3
No Patient Involvement 2 2
Abrasion 2 2
Necrosis 2 2
Non-union Bone Fracture 2 2
Spinal Cord Injury 1 1
Paraplegia 1 1
Weight Changes 1 1
Neuropathy 1 1
Synovitis 1 1
Adhesion(s) 1 1
Dysphagia/ Odynophagia 1 1
Edema 1 1
Hair Loss 1 1
Failure of Implant 1 1
Inflammation 1 1
Vertebral Fracture 1 1
Joint Laxity 1 1
Nervous System Injury 1 1

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