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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
Product CodeINN
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 17 62

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 57 57
Mechanical Problem 21 112
Mechanical Jam 21 88
Device Fell 16 76
Break 8 8
Sharp Edges 7 13
Detachment of Device or Device Component 7 7
Use of Device Problem 5 5
Insufficient Information 4 4
Fracture 4 4
Improper or Incorrect Procedure or Method 4 4
Collapse 2 2
Patient Device Interaction Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Misassembly by Users 2 2
Device Slipped 1 1
Unstable 1 1
Pressure Problem 1 1
Device Tipped Over 1 1
Crack 1 1
Unintended Movement 1 1
Defective Component 1 1
Defective Device 1 1
Positioning Failure 1 1
Structural Problem 1 2
Electrical Shorting 1 1
Component Misassembled 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 101 307
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
Encephalopathy 1 1
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
Contusion 1 1
Injury 1 1
Strangulation 1 1
Laceration(s) 1 1
Physical Entrapment 1 1
Pressure Sores 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
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