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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device burr, orthopedic
Product CodeHTT
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2018 2 2
2019 2 2
2020 2 2
2021 2 2
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Detachment of Device or Device Component 2 2
Overheating of Device 1 1
Physical Resistance/Sticking 1 1
Corroded 1 1
Material Discolored 1 1
Power Problem 1 1
Fracture 1 1
Device Operates Differently Than Expected 1 1
Retraction Problem 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 5 5
No Known Impact Or Consequence To Patient 3 3
No Consequences Or Impact To Patient 1 1
Burn(s) 1 1
No Information 1 1

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