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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device chair, examination and treatment
Product CodeFRK
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
Unintended Movement 5 6
Sharp Edges 5 7
Mechanical Problem 5 5
Loose or Intermittent Connection 4 4
Collapse 3 3
Appropriate Term/Code Not Available 3 3
Improper or Incorrect Procedure or Method 2 2
Difficult to Open or Close 2 2
Component Falling 2 2
Component Missing 2 2
Use of Device Problem 2 2
Device Tipped Over 2 2
Crack 2 2
Split 2 2
Material Integrity Problem 2 2
No Fail-Safe Mechanism 2 2
Device Displays Incorrect Message 1 1
Human-Device Interface Problem 1 1
Naturally Worn 1 1
Defective Alarm 1 1
Detachment of Device or Device Component 1 2
Retraction Problem 1 1
Positioning Problem 1 1
Malposition of Device 1 1
Failure to Align 1 1
Delamination 1 1
Noise, Audible 1 1
Device Inoperable 1 1
Patient Device Interaction Problem 1 1
Scratched Material 1 1
Insufficient Information 1 1
Disconnection 1 1
Activation, Positioning or Separation Problem 1 1
Unstable 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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