TPLC - Total Product Life Cycle

• Device: chair, examination and treatment
• Product Code: FRK
• Regulation Number: 880.6140
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2018	19	19
2019	7	9
2020	8	12
2021	4	4
2022	1	1
2023	2	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Twisted/Bent	8	8
Adverse Event Without Identified Device or Use Problem	5	5
Device Slipped	5	5
Unintended Movement	4	5
Sharp Edges	4	6
Device Fell	4	9
Break	3	3
Device Operates Differently Than Expected	3	3
Unintended System Motion	2	2
Appropriate Term/Code Not Available	2	2
Patient Device Interaction Problem	1	1
No Fail-Safe Mechanism	1	1
Defective Alarm	1	1
Collapse	1	1
Loose or Intermittent Connection	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Device Tipped Over	1	1
Detachment of Device or Device Component	1	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	15	15
No Clinical Signs, Symptoms or Conditions	9	16
No Consequences Or Impact To Patient	5	7
Fall	5	5
Pain	3	3
No Patient Involvement	3	4
Laceration(s)	2	2
Insufficient Information	2	2
Skin Tears	1	1
Bone Fracture(s)	1	1
Hemorrhage/Bleeding	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Stryker Medical Division of Stryker Corporation	II	Aug-06-2021