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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
2020 167 200
2021 58 71
2022 46 50
2023 65 330
2024 28 43
2025 13 35

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contaminated During Manufacture or Shipping 142 146
Packaging Problem 73 73
Detachment of Device or Device Component 61 350
Delivered as Unsterile Product 26 39
Material Disintegration 20 68
Unsealed Device Packaging 14 14
Insufficient Information 6 6
Tear, Rip or Hole in Device Packaging 6 6
Break 4 4
Defective Device 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Fracture 3 3
Difficult to Open or Remove Packaging Material 2 2
Crack 2 2
Patient Device Interaction Problem 2 2
Material Discolored 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Mechanical Jam 2 2
Activation, Positioning or Separation Problem 1 1
Pressure Problem 1 1
Material Split, Cut or Torn 1 1
Output Problem 1 1
Physical Resistance/Sticking 1 1
Contamination 1 1
Contamination /Decontamination Problem 1 1
Device Difficult to Setup or Prepare 1 1
Use of Device Problem 1 1
Improper Flow or Infusion 1 1
Material Twisted/Bent 1 1
Decrease in Pressure 1 1
Device Dislodged or Dislocated 1 1
Connection Problem 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 214 563
No Patient Involvement 132 153
No Known Impact Or Consequence To Patient 23 38
Insufficient Information 8 263
No Consequences Or Impact To Patient 7 25
No Information 4 4
Unspecified Infection 1 1
Death 1 1
Failure of Implant 1 1
Joint Disorder 1 1

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