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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
2020 112 112
2021 161 161
2022 93 93
2023 9 9
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Break 322 322
Fracture 26 26
Crack 16 16
Naturally Worn 14 14
Material Twisted/Bent 6 6
Component Missing 5 5
Detachment of Device or Device Component 5 5
Material Fragmentation 4 4
Labelling, Instructions for Use or Training Problem 4 4
Material Deformation 3 3
Material Separation 3 3
Scratched Material 2 2
Mechanical Jam 2 2
Device Damaged Prior to Use 1 1
Device Markings/Labelling Problem 1 1
Unintended Movement 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Mechanics Altered 1 1
Misassembled 1 1
Solder Joint Fracture 1 1
No Apparent Adverse Event 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 305 305
No Patient Involvement 38 38
No Known Impact Or Consequence To Patient 31 31
No Consequences Or Impact To Patient 15 15
Insufficient Information 6 6
No Information 3 3

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