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TPLC
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Device
mixer, cement, for clinical use
Product Code
JDZ
Regulation Number
888.4210
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
22
22
2019
33
39
2020
167
200
2021
58
71
2022
46
50
2023
18
67
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Contaminated During Manufacture or Shipping
133
133
Packaging Problem
63
63
Detachment of Device or Device Component
35
94
Delivered as Unsterile Product
29
38
Material Disintegration
18
55
Unsealed Device Packaging
11
11
Biocompatibility
8
8
Break
7
7
Tear, Rip or Hole in Device Packaging
5
5
Insufficient Information
5
5
Defective Device
4
4
Material Fragmentation
4
4
Disassembly
3
3
Crack
3
3
Metal Shedding Debris
3
3
Difficult to Open or Remove Packaging Material
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Mechanical Jam
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Patient Device Interaction Problem
2
2
Migration
2
2
Material Split, Cut or Torn
1
1
Physical Resistance/Sticking
1
1
Device Fell
1
1
Unclear Information
1
1
Pressure Problem
1
1
Output Problem
1
1
Material Twisted/Bent
1
1
Device Dislodged or Dislocated
1
1
Improper Flow or Infusion
1
1
Device Packaging Compromised
1
1
Unintended Power Up
1
1
Contamination
1
1
Flaked
1
1
Fracture
1
1
Connection Problem
1
1
Activation, Positioning or Separation Problem
1
1
Device Difficult to Setup or Prepare
1
1
Failure to Pump
1
1
Inadequacy of Device Shape and/or Size
1
1
Use of Device Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
151
177
No Clinical Signs, Symptoms or Conditions
127
223
No Consequences Or Impact To Patient
35
54
No Known Impact Or Consequence To Patient
30
45
No Information
6
6
Insufficient Information
4
43
Extravasation
2
2
Failure of Implant
1
1
Death
1
1
Not Applicable
1
1
Unspecified Infection
1
1
Joint Disorder
1
1
Hearing Loss
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Stryker Instruments Div. of Stryker Corporation
II
Mar-28-2018
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