TPLC - Total Product Life Cycle

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Device	chair, adjustable, mechanical
Regulation Description	Mechanical chair.
Product Code	INN
Regulation Number	890.3100
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Fragmentation	44	44
Mechanical Problem	25	124
Mechanical Jam	22	106
Device Fell	17	81
Sharp Edges	9	19
Detachment of Device or Device Component	8	8
Break	5	5
Insufficient Information	4	4
Fracture	4	4
Use of Device Problem	3	3
Unstable	2	2
Device Tipped Over	2	2
Collapse	2	2
Patient Device Interaction Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Misassembly by Users	2	2
Improper or Incorrect Procedure or Method	2	2
Pressure Problem	1	1
Crack	1	1
Unintended Movement	1	1
Defective Device	1	1
Positioning Failure	1	1
Electrical Shorting	1	1
Device Dislodged or Dislocated	1	4
Device Contaminated at the User Facility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	116	362
No Known Impact Or Consequence To Patient	10	10
No Patient Involvement	8	22
Fall	7	7
Insufficient Information	6	6
No Consequences Or Impact To Patient	5	5
Pain	4	4
Bone Fracture(s)	2	2
Tooth Fracture	2	2
Damage to Ligament(s)	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Bowel Perforation	1	1
Head Injury	1	1
Abrasion	1	1
Strangulation	1	1
Laceration(s)	1	1
Physical Entrapment	1	1
Vertebral Fracture	1	1
Urinary Tract Infection	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