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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 22 22
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Break 26 26
Fracture 23 23
Loosening of Implant Not Related to Bone-Ingrowth 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Insufficient Information 3 3
Migration or Expulsion of Device 3 3
Loose or Intermittent Connection 2 2
Material Deformation 2 2
Naturally Worn 1 1
Scratched Material 1 1
Appropriate Term/Code Not Available 1 1
Mechanical Problem 1 1
Crack 1 1
Positioning Failure 1 1
Material Separation 1 1
Use of Device Problem 1 1
Failure to Advance 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 23 23
No Clinical Signs, Symptoms or Conditions 23 23
Pain 10 10
Foreign Body In Patient 6 6
Loss of Range of Motion 5 5
Failure of Implant 5 5
Insufficient Information 4 4
Subluxation 4 4
Non-union Bone Fracture 4 4
Joint Dislocation 4 4
Rheumatoid Arthritis 4 4
Bone Fracture(s) 4 4
No Patient Involvement 2 2
Unequal Limb Length 2 2
No Known Impact Or Consequence To Patient 1 1
No Code Available 1 1
Hemorrhage/Bleeding 1 1
Erosion 1 1
Connective Tissue Disease 1 1

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