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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dispenser, cement
Regulation Description Cement dispenser.
Product CodeKIH
Regulation Number 888.4200
Device Class 1

MDR Year MDR Reports MDR Events
2020 23 23
2021 30 30
2022 26 26
2023 30 30
2024 19 19
2025 93 93
2026 18 19

Device Problems MDRs with this Device Problem Events in those MDRs
Break 57 57
Leak/Splash 54 54
Mechanical Jam 39 39
Mechanical Problem 24 24
Mechanics Altered 16 16
Adverse Event Without Identified Device or Use Problem 14 14
Failure to Eject 11 11
Device-Device Incompatibility 9 9
Contamination /Decontamination Problem 9 9
Device Contaminated During Manufacture or Shipping 7 7
Use of Device Problem 5 5
Chemical Problem 4 4
Entrapment of Device 4 4
Loss of or Failure to Bond 4 4
Material Deformation 3 3
Material Fragmentation 2 3
Failure to Align 2 2
Delivered as Unsterile Product 2 2
Packaging Problem 2 2
Connection Problem 2 2
Migration or Expulsion of Device 1 1
Off-Label Use 1 1
Malposition of Device 1 1
Output Problem 1 1
Incomplete or Inadequate Connection 1 1
Difficult to Advance 1 1
Expiration Date Error 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Remove 1 1
Backflow 1 1
Obstruction of Flow 1 1
Infusion or Flow Problem 1 1
Product Quality Problem 1 1
Material Separation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Detachment of Device or Device Component 1 1
Appropriate Device Problem Term/Code Not Available 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 176 177
Insufficient Information 12 12
No Consequences Or Impact To Patient 10 10
Unspecified Infection 8 8
Pain 8 8
Extravasation 7 7
Foreign Body In Patient 6 6
No Known Impact Or Consequence To Patient 3 3
Device Embedded In Tissue or Plaque 3 3
No Code Available 2 2
Abrasion 2 2
No Patient Involvement 2 2
Neuropathy 1 1
Weight Changes 1 1
Failure of Implant 1 1
Joint effusion 1 1
Adhesion(s) 1 1
Inflammation 1 1
Synovitis 1 1
Edema 1 1
Hair Loss 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Nonunion/Delayed-union Bone Fracture 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

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