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TPLC
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show TPLC since
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Device
apparatus, traction, non-powered
Product Code
HST
Regulation Number
888.5850
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
25
25
2019
32
32
2020
37
37
2021
40
40
2022
26
26
2023
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
33
33
Device-Device Incompatibility
22
22
Adverse Event Without Identified Device or Use Problem
14
14
Positioning Failure
11
11
Unintended Movement
11
11
Unstable
8
8
Material Twisted/Bent
8
8
Positioning Problem
7
7
Detachment Of Device Component
6
6
Mechanical Problem
5
5
Use of Device Problem
5
5
Mechanical Jam
5
5
Material Deformation
5
5
Detachment of Device or Device Component
5
5
Physical Resistance/Sticking
5
5
Insufficient Information
4
4
Device Slipped
3
3
Degraded
2
2
Material Separation
2
2
Fracture
2
2
Material Fragmentation
2
2
Loose or Intermittent Connection
2
2
Device Markings/Labelling Problem
2
2
Device Operates Differently Than Expected
2
2
Therapeutic or Diagnostic Output Failure
2
2
Appropriate Term/Code Not Available
2
2
Patient Device Interaction Problem
1
1
Device Fell
1
1
Physical Property Issue
1
1
Material Integrity Problem
1
1
Material Protrusion/Extrusion
1
1
Naturally Worn
1
1
Device Unsafe to Use in Environment
1
1
Device Dislodged or Dislocated
1
1
Electromagnetic Compatibility Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Peeled/Delaminated
1
1
Material Too Rigid or Stiff
1
1
Crack
1
1
Inadequate or Insufficient Training
1
1
Fitting Problem
1
1
Failure to Align
1
1
Defective Device
1
1
Patient-Device Incompatibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
69
69
No Known Impact Or Consequence To Patient
42
42
No Consequences Or Impact To Patient
22
22
No Patient Involvement
14
14
Foreign Body In Patient
4
4
Pain
3
3
Bone Fracture(s)
2
2
Laceration(s)
2
2
Nerve Damage
2
2
Injury
2
2
Hip Fracture
2
2
No Code Available
2
2
Insufficient Information
2
2
Numbness
1
1
Device Embedded In Tissue or Plaque
1
1
Abrasion
1
1
Eye Injury
1
1
Fall
1
1
Swelling
1
1
Visual Impairment
1
1
Visual Disturbances
1
1
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