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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apparatus, traction, non-powered
Product CodeHST
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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