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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device trephine
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWK
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 13 13
2021 10 10
2022 5 5
2023 9 9
2024 8 8
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 42 42
Entrapment of Device 5 5
Material Integrity Problem 2 2
Device-Device Incompatibility 1 1
Use of Device Problem 1 1
Material Twisted/Bent 1 1
Fracture 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 33 33
Foreign Body In Patient 5 5
Insufficient Information 4 4
No Consequences Or Impact To Patient 4 4
No Patient Involvement 3 3
No Code Available 2 2
Injury 2 2

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