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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device passer, wire, orthopedic
Regulation Description Orthopedic manual surgical instrument.
Product CodeHXI
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 5 5
2021 2 2
2022 8 8
2023 12 12
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 16 16
Detachment of Device or Device Component 5 5
Fracture 5 5
Patient Device Interaction Problem 2 2
Material Fragmentation 2 2
Defective Device 1 1
Difficult to Remove 1 1
Use of Device Problem 1 1
Material Separation 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
Foreign Body In Patient 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Insufficient Information 4 4
Blister 3 3
Rash 3 3
Rheumatoid Arthritis 1 1
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Device Embedded In Tissue or Plaque 1 1

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