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TPLC
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show TPLC since
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2024
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Device
chair, examination and treatment
Product Code
FRK
Regulation Number
880.6140
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
41
41
2015
29
29
2016
20
20
2017
22
22
2018
19
19
2019
7
9
2020
8
12
2021
4
4
2022
1
1
2023
5
8
2024
2
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
45
45
Device Slipped
25
25
Bent
19
19
Device Operates Differently Than Expected
14
14
Material Twisted/Bent
11
11
Unintended System Motion
10
10
Adverse Event Without Identified Device or Use Problem
9
9
Device Fell
7
13
Detachment Of Device Component
6
6
Sharp Edges
5
7
Mechanical Problem
5
5
Unintended Movement
5
6
Loose or Intermittent Connection
4
4
Collapse
3
3
Appropriate Term/Code Not Available
3
3
Use of Device Problem
2
2
Component Missing
2
2
Material Integrity Problem
2
2
No Fail-Safe Mechanism
2
2
Split
2
2
Crack
2
2
Device Tipped Over
2
2
Difficult to Open or Close
2
2
Component Falling
2
2
Improper or Incorrect Procedure or Method
2
2
Patient Device Interaction Problem
1
1
Scratched Material
1
1
Positioning Problem
1
1
Malposition of Device
1
1
Noise, Audible
1
1
Device Displays Incorrect Message
1
1
Device Inoperable
1
1
Defective Alarm
1
1
Insufficient Information
1
1
Disconnection
1
1
Activation, Positioning or Separation Problem
1
1
Unstable
1
1
Naturally Worn
1
1
Human-Device Interface Problem
1
1
Detachment of Device or Device Component
1
2
Retraction Problem
1
1
Failure to Align
1
1
Delamination
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
86
86
No Consequences Or Impact To Patient
20
22
Fall
18
18
No Clinical Signs, Symptoms or Conditions
13
21
Injury
6
6
No Patient Involvement
5
6
Pain
5
5
No Information
3
3
Bone Fracture(s)
3
3
Laceration(s)
3
3
Crushing Injury
2
2
Insufficient Information
2
2
Bruise/Contusion
2
2
Wound Dehiscence
1
1
No Code Available
1
1
Cusp Tear
1
1
Swelling
1
1
Skin Tears
1
1
Headache
1
1
Hemorrhage/Bleeding
1
1
Infection, Direct
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Stryker Medical Division of Stryker Corporation
II
Aug-06-2021
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