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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device elevator, surgical, dental
Regulation Description Dental hand instrument.
Product CodeEMJ
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2018 68 68
2019 73 73
2020 39 39
2021 65 65
2022 46 46
2023 45 45
2024 27 27
2025 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 348 348
Break 19 19
Crack 8 8
Material Fragmentation 5 5
Material Integrity Problem 2 2
Degraded 1 1
Material Twisted/Bent 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Device Or Device Fragments Location Unknown 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 174 174
No Consequences Or Impact To Patient 116 116
No Known Impact Or Consequence To Patient 62 62
No Information 10 10
Foreign Body In Patient 10 10
No Patient Involvement 6 6
Insufficient Information 2 2
Device Embedded In Tissue or Plaque 2 2
Injury 1 1
Needle Stick/Puncture 1 1
Pain 1 1
Laceration(s) 1 1

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