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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device trousers, anti-shock
Product CodeLHX
Regulation Number 870.5800
Device Class 2

MDR Year MDR Reports MDR Events
2019 26 26
2020 2 2
2021 5 5
2022 14 14
2023 23 23
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Break 27 27
Fracture 24 24
Loosening of Implant Not Related to Bone-Ingrowth 9 9
Adverse Event Without Identified Device or Use Problem 7 7
Insufficient Information 4 4
Migration or Expulsion of Device 3 3
Detachment of Device or Device Component 2 2
Loose or Intermittent Connection 2 2
Material Deformation 2 2
Crack 1 1
Material Separation 1 1
Failure to Advance 1 1
Device Dislodged or Dislocated 1 1
Appropriate Term/Code Not Available 1 1
Mechanical Problem 1 1
Naturally Worn 1 1
Scratched Material 1 1
Positioning Failure 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24 24
No Consequences Or Impact To Patient 23 23
Pain 10 10
Foreign Body In Patient 7 7
Failure of Implant 5 5
Loss of Range of Motion 5 5
Insufficient Information 5 5
Rheumatoid Arthritis 4 4
Joint Dislocation 4 4
Bone Fracture(s) 4 4
Subluxation 4 4
Non-union Bone Fracture 4 4
No Patient Involvement 2 2
Unequal Limb Length 2 2
Erosion 2 2
No Code Available 1 1
No Known Impact Or Consequence To Patient 1 1
Connective Tissue Disease 1 1
Hemorrhage/Bleeding 1 1

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