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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

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 29 29
Mechanical Problem 26 141
Mechanical Jam 23 150
Device Fell 16 75
Sharp Edges 12 25
Detachment of Device or Device Component 7 7
Unstable 6 21
Insufficient Information 4 4
Use of Device Problem 4 4
Device Tipped Over 2 2
Patient Device Interaction Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Fracture 2 2
Crack 1 1
Positioning Failure 1 1
Electrical Shorting 1 1
No Apparent Adverse Event 1 1
Protective Measures Problem 1 1
Appropriate Term/Code Not Available 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 121 450
Insufficient Information 5 5
Fall 4 4
Pain 3 3
Limb Fracture 2 2
Device Embedded In Tissue or Plaque 2 2
Damage to Ligament(s) 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Bone Fracture(s) 1 1
Head Injury 1 1
Tooth Fracture 1 1
Strangulation 1 1
Laceration(s) 1 1
Physical Entrapment 1 1
Skin Tears 1 1
Pressure Sores 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
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