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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mixer, cement, for clinical use
Regulation Description Cement mixer for clinical use.
Product CodeJDZ
Regulation Number 888.4210
Device Class 1

MDR Year MDR Reports MDR Events
2021 58 71
2022 46 50
2023 65 330
2024 28 43
2025 20 42

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 61 345
Packaging Problem 60 60
Delivered as Unsterile Product 22 32
Material Disintegration 16 39
Unsealed Device Packaging 14 14
Device Contaminated During Manufacture or Shipping 13 17
Tear, Rip or Hole in Device Packaging 5 5
Break 3 3
Defective Device 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Fracture 3 3
Difficult to Open or Remove Packaging Material 2 2
Crack 2 2
Material Discolored 2 2
Activation, Positioning or Separation Problem 1 1
Pressure Problem 1 1
Material Split, Cut or Torn 1 1
Insufficient Information 1 1
Contamination 1 1
Contamination /Decontamination Problem 1 1
Patient Device Interaction Problem 1 1
No Pressure 1 1
Device Difficult to Setup or Prepare 1 1
Improper Flow or Infusion 1 1
Decrease in Pressure 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 211 530
Insufficient Information 10 265
Unspecified Infection 1 1
Failure of Implant 1 1
Joint Disorder 1 1

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