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