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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
2018 126 126
2019 114 114
2020 117 117
2021 82 82
2022 114 114
2023 132 132

Device Problems MDRs with this Device Problem Events in those MDRs
Break 158 158
Adverse Event Without Identified Device or Use Problem 76 76
Fracture 56 56
Collapse 38 38
Insufficient Information 33 33
Detachment of Device or Device Component 33 33
Appropriate Term/Code Not Available 31 31
Use of Device Problem 30 30
Unintended Movement 29 29
Material Fragmentation 24 24
Material Integrity Problem 22 22
Material Twisted/Bent 20 20
Solder Joint Fracture 18 18
Mechanical Problem 16 16
Sharp Edges 12 12
Device Slipped 11 11
Improper or Incorrect Procedure or Method 8 8
Defective Component 7 7
Unstable 7 7
Crack 7 7
Device Tipped Over 7 7
Loose or Intermittent Connection 6 6
Detachment Of Device Component 6 6
Material Separation 6 6
Device Damaged Prior to Use 5 5
Device Dislodged or Dislocated 5 5
Device Fell 5 5
Patient Device Interaction Problem 5 5
Defective Device 4 4
Component Missing 4 4
Failure to Align 4 4
Component Falling 3 3
Unintended System Motion 3 3
Off-Label Use 3 3
Human-Device Interface Problem 3 3
Mechanical Jam 3 3
Device Operates Differently Than Expected 3 3
Device Unsafe to Use in Environment 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Material Deformation 2 2
No Apparent Adverse Event 2 2
Material Protrusion/Extrusion 2 2
Protective Measures Problem 2 2
Device Handling Problem 2 2
Misassembled During Installation 2 2
Product Quality Problem 2 2
Structural Problem 2 2
Unintended Collision 2 2
Sticking 2 2
Accessory Incompatible 1 1
Inadequacy of Device Shape and/or Size 1 1
Failure to Advance 1 1
Self-Activation or Keying 1 1
Device Maintenance Issue 1 1
Degraded 1 1
Material Frayed 1 1
Labelling, Instructions for Use or Training Problem 1 1
Separation Problem 1 1
Physical Resistance/Sticking 1 1
Misassembly by Users 1 1
Difficult to Open or Close 1 1
Mechanics Altered 1 1
Naturally Worn 1 1
Inadequate User Interface 1 1
Installation-Related Problem 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Folded 1 1
Patient-Device Incompatibility 1 1
Device Misassembled During Manufacturing /Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 327 327
Bone Fracture(s) 128 128
Laceration(s) 104 104
Head Injury 50 50
Bruise/Contusion 50 50
No Clinical Signs, Symptoms or Conditions 33 33
Pain 28 28
Injury 28 28
Hip Fracture 26 26
No Known Impact Or Consequence To Patient 22 22
Insufficient Information 19 19
Limb Fracture 12 12
Fracture, Arm 12 12
Concussion 12 12
Easy Bruising 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Joint Dislocation 8 8
Vertebral Fracture 7 7
Neck Pain 6 6
Abrasion 6 6
Damage to Ligament(s) 6 6
No Consequences Or Impact To Patient 5 5
Muscle/Tendon Damage 5 5
Swelling/ Edema 5 5
Skin Tears 4 4
No Code Available 4 4
Spinal Column Injury 4 4
Hematoma 4 4
Contusion 3 3
Brain Injury 3 3
Tooth Fracture 3 3
Unspecified Tissue Injury 3 3
Multiple Fractures 2 2
Eye Injury 2 2
No Patient Involvement 2 2
Post Traumatic Wound Infection 2 2
Patient Problem/Medical Problem 2 2
Death 2 2
Hemorrhage/Bleeding 2 2
Headache 2 2
Swelling 2 2
Loss of Vision 2 2
Loss of consciousness 2 2
Weakness 1 1
Rupture 1 1
Vertigo 1 1
Strangulation 1 1
Pneumonia 1 1
Loss of Range of Motion 1 1
Scar Tissue 1 1
Hearing Loss 1 1
Wound Dehiscence 1 1
Chest Pain 1 1
Hemorrhage, Cerebral 1 1
Intracranial Hemorrhage 1 1
Hemorrhage, Subdural 1 1
Erythema 1 1
Memory Loss/Impairment 1 1
Disc Impingement 1 1
Foreign Body In Patient 1 1
Balance Problems 1 1
No Information 1 1
Physical Entrapment 1 1
Ambulation Difficulties 1 1
Cognitive Changes 1 1
Sweating 1 1
Skin Infection 1 1
Drug Resistant Bacterial Infection 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 Nova Ortho-Med Inc II Dec-21-2020
6 R82 A/S II May-04-2020
7 SVS LLC II Nov-20-2018
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