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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device walker, mechanical
Product CodeITJ
Regulation Number 890.3825
Device Class 1

MDR Year MDR Reports MDR Events
2020 117 117
2021 81 81
2022 114 114
2023 140 140
2024 84 84

Device Problems MDRs with this Device Problem Events in those MDRs
Break 102 102
Fracture 49 49
Adverse Event Without Identified Device or Use Problem 45 45
Appropriate Term/Code Not Available 44 44
Mechanical Problem 40 40
Insufficient Information 31 31
Material Integrity Problem 23 23
Use of Device Problem 22 22
Unintended Movement 20 20
Material Twisted/Bent 18 18
Detachment of Device or Device Component 17 17
Material Fragmentation 15 15
Collapse 13 13
Sharp Edges 13 13
Solder Joint Fracture 11 11
Improper or Incorrect Procedure or Method 7 7
Defective Component 7 7
Crack 5 5
Off-Label Use 4 4
Loose or Intermittent Connection 4 4
Patient Device Interaction Problem 4 4
Component Missing 4 4
Failure to Align 4 4
Device Dislodged or Dislocated 4 4
Device Slipped 3 3
Device Damaged Prior to Use 3 3
Device Fell 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Unintended System Motion 3 3
Unintended Collision 2 2
Mechanical Jam 2 2
Naturally Worn 2 2
Human-Device Interface Problem 2 2
Protective Measures Problem 2 2
No Apparent Adverse Event 2 2
Material Protrusion/Extrusion 2 2
Material Separation 2 2
Product Quality Problem 2 2
Material Deformation 2 2
Device Unsafe to Use in Environment 2 2
Structural Problem 2 2
Defective Device 2 2
Unstable 2 2
Material Frayed 2 2
Device Handling Problem 1 1
Misassembly by Users 1 1
Failure to Advance 1 1
Degraded 1 1
Misassembled During Installation 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 210 210
Laceration(s) 98 98
Bone Fracture(s) 83 83
No Clinical Signs, Symptoms or Conditions 43 43
Bruise/Contusion 42 42
Head Injury 39 39
Pain 27 27
Insufficient Information 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Limb Fracture 15 15
Hip Fracture 14 14
Concussion 14 14
Damage to Ligament(s) 10 10
Easy Bruising 10 10
Vertebral Fracture 8 8
Abrasion 7 7
Joint Dislocation 6 6
Swelling/ Edema 6 6
Skin Tears 5 5
Muscle/Tendon Damage 5 5
Neck Pain 5 5
No Consequences Or Impact To Patient 4 4
Brain Injury 4 4
No Known Impact Or Consequence To Patient 4 4
Injury 4 4
Unspecified Tissue Injury 3 3
Hematoma 3 3
Tooth Fracture 3 3
Hemorrhage/Bleeding 2 2
Headache 2 2
Multiple Fractures 2 2
Vertigo 1 1
Strangulation 1 1
No Patient Involvement 1 1
Erythema 1 1
Foreign Body In Patient 1 1
Spinal Column Injury 1 1
Cognitive Changes 1 1
Scar Tissue 1 1
Balance Problems 1 1
Eye Injury 1 1
Physical Entrapment 1 1
Perforation 1 1
Non-union Bone Fracture 1 1
Skull Fracture 1 1
Memory Loss/Impairment 1 1
Myocardial Infarction 1 1
Drug Resistant Bacterial Infection 1 1
Convulsion/Seizure 1 1
Sweating 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Breg Inc II Nov-03-2023
2 Compass Health Brands (Corporate Office) II Jan-19-2022
3 Invacare Corporation II Aug-23-2023
4 James Leckey Design Ltd II May-27-2021
5 Medical Depot Inc. II Jul-12-2024
6 Nova Ortho-Med Inc II Oct-17-2024
7 Nova Ortho-Med Inc II Dec-21-2020
8 R82 A/S II May-04-2020
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