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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device driver, surgical, pin
Product CodeGFC
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 4 4
2021 8 8
2022 7 7
2023 7 7
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 14 14
Fracture 6 6
Detachment of Device or Device Component 2 2
Material Deformation 2 2
Excessive Heating 2 2
Premature Separation 1 1
Illegible Information 1 1
Material Twisted/Bent 1 1
Degraded 1 1
Fail-Safe Problem 1 1
Compatibility Problem 1 1
Material Fragmentation 1 1
Leak/Splash 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23 23
Insufficient Information 3 3
No Consequences Or Impact To Patient 2 2
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1

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