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TPLC
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Device
mixer, cement, for clinical use
Regulation Description
Cement mixer for clinical use.
Product Code
JDZ
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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