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TPLC
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show TPLC since
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Device
walker, mechanical
Product Code
ITJ
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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