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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
2020 39 39
2021 65 65
2022 46 46
2023 45 45
2024 27 27
2025 43 43
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 220 220
Naturally Worn 21 21
Break 13 13
Crack 8 8
Material Fragmentation 4 4
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
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 201 201
No Known Impact Or Consequence To Patient 37 37
No Consequences Or Impact To Patient 18 18
Foreign Body In Patient 8 8
No Patient Involvement 2 2
Insufficient Information 2 2
Needle Stick/Puncture 1 1
Laceration(s) 1 1
Pain 1 1
Device Embedded In Tissue or Plaque 1 1

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