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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 28 43

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contaminated During Manufacture or Shipping 138 142
Packaging Problem 73 73
Detachment of Device or Device Component 65 347
Delivered as Unsterile Product 37 50
Material Disintegration 21 60
Unsealed Device Packaging 14 14
Tear, Rip or Hole in Device Packaging 7 7
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
Patient Device Interaction Problem 2 2
Material Discolored 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Migration 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
Unintended Power Up 1 1
Device Fell 1 1
Contamination 1 1
Contamination /Decontamination Problem 1 1
Material Fragmentation 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
Inadequacy of Device Shape and/or Size 1 1
Device Dislodged or Dislocated 1 1
Connection Problem 1 1
Flaked 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 202 529
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
Failure of Implant 1 1
Joint Disorder 1 1
Not Applicable 1 1
Extravasation 1 1

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