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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device chair, adjustable, mechanical
Regulation Description Mechanical chair.
Product CodeINN
Regulation Number 890.3100
Device Class 1

MDR Year MDR Reports MDR Events
2021 30 67
2022 32 90
2023 22 86
2024 25 88
2025 35 142
2026 19 57

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 31 155
Material Fragmentation 29 29
Mechanical Jam 25 178
Device Fell 18 78
Sharp Edges 14 29
Detachment of Device or Device Component 7 7
Unstable 6 21
Insufficient Device Problem Information 4 4
Use of Device Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Device Tipped Over 2 2
Patient Device Interaction Problem 2 2
Fracture 2 2
Appropriate Device Problem Term/Code Not Available 1 1
Unintended Movement 1 1
Crack 1 1
No Apparent Adverse Event 1 1
Dent in Material 1 1
Electrical Shorting 1 1
Material Integrity Problem 1 1
Positioning Failure 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 135 502
Insufficient Information 6 6
Fall 5 5
Pain 4 4
Limb Fracture 2 2
Skin Tears 2 2
Device Embedded In Tissue or Plaque 2 2
Bone Fracture(s) 1 1
Damage to Ligament(s) 1 1
Hip Fracture 1 1
Pressure Sore/Ulcer 1 1
Physical Entrapment 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1
Laceration(s) 1 1
Vertebral Fracture 1 1
Heart Failure/Congestive Heart Failure 1 1
Strangulation 1 1
Tooth Fracture 1 1
Ambulation or Postural Difficulties 1 1
Head Injury 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 Raz Design Inc II Mar-06-2026
4 Stryker Medical Division of Stryker Corporation II Aug-06-2021
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