TPLC - Total Product Life Cycle

• Device: chair, adjustable, mechanical
• Product Code: INN
• Regulation Number: 890.3100
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2019	29	37
2020	43	59
2021	30	67
2022	32	90
2023	22	86
2024	8	12

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Fragmentation	55	55
Mechanical Jam	19	71
Mechanical Problem	19	85
Device Fell	16	76
Break	8	8
Detachment of Device or Device Component	6	6
Sharp Edges	6	11
Insufficient Information	4	4
Improper or Incorrect Procedure or Method	4	4
Fracture	4	4
Use of Device Problem	4	4
Adverse Event Without Identified Device or Use Problem	2	2
Collapse	2	2
Patient Device Interaction Problem	2	2
Misassembly by Users	2	2
Positioning Failure	1	1
Unintended Movement	1	1
Pressure Problem	1	1
Electrical Shorting	1	1
Crack	1	1
Device Slipped	1	1
Defective Device	1	1
Component Misassembled	1	1
Device Dislodged or Dislocated	1	4
Device Tipped Over	1	1
Structural Problem	1	2
Device Contaminated at the User Facility	1	1
Defective Component	1	1
Unstable	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	93	258
No Known Impact Or Consequence To Patient	28	28
No Patient Involvement	13	35
Fall	9	9
Insufficient Information	6	6
No Consequences Or Impact To Patient	5	5
Bone Fracture(s)	3	3
Pain	3	3
Tooth Fracture	2	2
Strangulation	1	1
Urinary Tract Infection	1	1
Abrasion	1	1
Contusion	1	1
Encephalopathy	1	1
Head Injury	1	1
Laceration(s)	1	1
Damage to Ligament(s)	1	1
Pressure Sores	1	1
Injury	1	1
Bowel Perforation	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Vertebral Fracture	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Altimate Medical, Inc.	II	Jan-04-2023
2	R82 A/S	II	Feb-08-2022
3	Stryker Medical Division of Stryker Corporation	II	Aug-06-2021