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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tape, measuring, rulers and calipers
Regulation Description Manual surgical instrument for general use.
Product CodeFTY
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2021 161 161
2022 93 93
2023 9 9
2024 12 12
2025 9 9
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 226 226
Fracture 29 29
Naturally Worn 14 14
Crack 10 10
Material Twisted/Bent 6 6
Detachment of Device or Device Component 6 6
Component Missing 5 5
Material Deformation 4 4
Labelling, Instructions for Use or Training Problem 4 4
Scratched Material 3 3
Unintended Movement 2 2
Material Fragmentation 2 2
Mechanical Jam 2 2
Device-Device Incompatibility 1 1
Device Damaged Prior to Use 1 1
Device Markings/Labelling Problem 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Mechanics Altered 1 1
Calibration Problem 1 1
Incorrect Measurement 1 1
Material Separation 1 1
Connection Problem 1 1
Difficult to Open or Close 1 1
Corroded 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 279 279
Insufficient Information 6 6

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