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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
Product CodeJDZ
Regulation Number 888.4210
Device Class 1

MDR Year MDR Reports MDR Events
2019 33 39
2020 167 200
2021 58 71
2022 46 50
2023 65 330
2024 17 28

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contaminated During Manufacture or Shipping 134 134
Packaging Problem 73 73
Detachment of Device or Device Component 64 346
Delivered as Unsterile Product 37 50
Material Disintegration 19 56
Unsealed Device Packaging 14 14
Break 6 6
Insufficient Information 6 6
Defective Device 4 4
Difficult to Open or Remove Packaging Material 3 3
Crack 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Fracture 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Migration 2 2
Tear, Rip or Hole in Device Packaging 2 2
Patient Device Interaction Problem 2 2
Material Discolored 2 2
Mechanical Jam 2 2
Material Fragmentation 1 1
Decrease in Pressure 1 1
Inadequacy of Device Shape and/or Size 1 1
Activation, Positioning or Separation Problem 1 1
Pressure Problem 1 1
Material Split, Cut or Torn 1 1
Contamination 1 1
Contamination /Decontamination Problem 1 1
Improper Flow or Infusion 1 1
Material Twisted/Bent 1 1
Use of Device Problem 1 1
Device Difficult to Setup or Prepare 1 1
Improper or Incorrect Procedure or Method 1 1
Flaked 1 1
Output Problem 1 1
Physical Resistance/Sticking 1 1
Unintended Power Up 1 1
Device Fell 1 1
Device Dislodged or Dislocated 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 191 514
No Patient Involvement 144 170
No Known Impact Or Consequence To Patient 29 44
No Consequences Or Impact To Patient 23 42
Insufficient Information 8 263
No Information 4 4
Unspecified Infection 1 1
Death 1 1
Hearing Loss 1 1
Not Applicable 1 1
Failure of Implant 1 1
Joint Disorder 1 1
Extravasation 1 1

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