TPLC - Total Product Life Cycle

• Device: stool, operating-room
• Product Code: FZM
• Regulation Number: 878.4950
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	58	58
2015	59	59
2017	14	14
2018	17	17
2019	4	10
2020	13	26
2021	13	27
2022	10	26
2023	12	25
2024	1	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Slipped	82	119
Component Missing	39	39
Break	27	27
Device Operates Differently Than Expected	16	16
Unstable	15	32
Mechanical Problem	11	11
Device Fell	11	17
Unintended Movement	9	15
Device Inoperable	9	9
Unintended System Motion	4	4
Detachment Of Device Component	4	4
Device Tipped Over	3	3
Naturally Worn	3	3
Positioning Problem	3	3
Material Integrity Problem	2	2
Sharp Edges	2	2
Vibration	2	2
Sticking	2	2
Bent	2	2
Loose or Intermittent Connection	2	2
Material Separation	1	1
Component Falling	1	1
Corroded	1	1
Crack	1	1
Material Disintegration	1	1
Fluid/Blood Leak	1	1
Fitting Problem	1	1
Malposition of Device	1	1
Connection Problem	1	1
Failure to Align	1	1
Difficult or Delayed Activation	1	1
Misassembly by Users	1	1
Insufficient Information	1	1
Mechanics Altered	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	119	119
No Clinical Signs, Symptoms or Conditions	39	94
No Consequences Or Impact To Patient	24	24
No Patient Involvement	16	27
Fall	2	3
Bruise/Contusion	1	1
Physical Entrapment	1	1
No Information	1	1

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