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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device trephine
Product CodeHWK
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2014 5 5
2015 5 5
2016 6 6
2017 7 7
2018 14 14
2019 12 12
2020 13 13
2021 10 10
2022 5 5
2023 9 9
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 77 77
Entrapment of Device 7 7
Material Twisted/Bent 3 3
Material Fragmentation 2 2
Material Integrity Problem 2 2
Difficult to Insert 1 1
Material Separation 1 1
Use of Device Problem 1 1
Device Or Device Fragments Location Unknown 1 1
Device-Device Incompatibility 1 1
Material Deformation 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Appropriate Term/Code Not Available 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26 26
No Known Impact Or Consequence To Patient 18 18
No Patient Involvement 13 13
Foreign Body In Patient 11 11
No Consequences Or Impact To Patient 9 9
No Code Available 6 6
Injury 3 3
Device Embedded In Tissue or Plaque 2 2
No Information 2 2
Sedation 1 1
Unspecified Infection 1 1
Laceration(s) 1 1
Insufficient Information 1 1

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