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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
Product CodeEMJ
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2014 19 19
2015 44 44
2016 85 85
2017 59 59
2018 68 68
2019 73 73
2020 39 39
2021 65 65
2022 46 46
2023 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 449 449
Break 91 91
Bent 9 9
Crack 8 8
Material Fragmentation 5 5
Off-Label Use 3 3
Material Separation 1 1
Device Inoperable 1 1
Use of Device Problem 1 1
Device Or Device Fragments Location Unknown 1 1
Detachment of Device or Device Component 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Insufficient Information 1 1
Degraded 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 204 204
No Consequences Or Impact To Patient 161 161
No Clinical Signs, Symptoms or Conditions 134 134
No Information 18 18
No Code Available 13 13
Foreign Body In Patient 10 10
No Patient Involvement 7 7
Insufficient Information 2 2
Device Embedded In Tissue or Plaque 1 1
Injury 1 1
Needle Stick/Puncture 1 1
Foreign Body Reaction 1 1
Unspecified Infection 1 1
Laceration(s) 1 1
Pain 1 1

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