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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 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Break 57 57
Leak/Splash 53 53
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
Contamination /Decontamination Problem 9 9
Device-Device Incompatibility 9 9
Device Contaminated During Manufacture or Shipping 6 6
Use of Device Problem 5 5
Chemical Problem 4 4
Loss of or Failure to Bond 4 4
Entrapment of Device 4 4
Connection Problem 2 2
Material Deformation 2 2
Packaging Problem 2 2
Failure to Align 2 2
Detachment of Device or Device Component 1 1
Difficult to Advance 1 1
Infusion or Flow Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Naturally Worn 1 1
Output Problem 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Improper or Incorrect Procedure or Method 1 1
Tear, Rip or Hole in Device Packaging 1 1
Obstruction of Flow 1 1
Expiration Date Error 1 1
Malposition of Device 1 1
Backflow 1 1
Fracture 1 1
Material Fragmentation 1 1
Migration or Expulsion of Device 1 1
Delivered as Unsterile Product 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Material Separation 1 1
Incomplete or Inadequate Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 172 172
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
Device Embedded In Tissue or Plaque 3 3
No Known Impact Or Consequence To Patient 3 3
Abrasion 2 2
No Patient Involvement 2 2
No Code Available 2 2
Edema 1 1
Failure of Implant 1 1
Dysphagia/ Odynophagia 1 1
Inflammation 1 1
Joint effusion 1 1
Adhesion(s) 1 1
Vertebral Fracture 1 1
Nervous System Injury 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Hair Loss 1 1
Neuropathy 1 1
Spinal Cord Injury 1 1
Nonunion/Delayed-union Bone Fracture 1 1
Synovitis 1 1
Weight Changes 1 1
Paraplegia 1 1
Joint Laxity 1 1

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