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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device hook, surgical, general & plastic surgery
Regulation Description Manual surgical instrument for general use.
Product CodeGDG
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2016 14 14
2017 7 7
2018 11 11
2019 6 6
2020 9 9
2021 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Break 45 45
Fracture 7 7
Material Fragmentation 4 4
Detachment Of Device Component 4 4
Entrapment of Device 3 3
Device Slipped 2 2
Component Missing 1 1
Device Or Device Fragments Location Unknown 1 1
Device Operates Differently Than Expected 1 1
Material Split, Cut or Torn 1 1
Migration or Expulsion of Device 1 1
Difficult to Remove 1 1
Material Separation 1 1
No Audible Alarm 1 1
Compatibility Problem 1 1
Positioning Problem 1 1
Device Fell 1 1
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 16 16
No Consequences Or Impact To Patient 14 14
No Clinical Signs, Symptoms or Conditions 8 8
Device Embedded In Tissue or Plaque 7 7
No Patient Involvement 6 6
Foreign Body In Patient 5 5
No Information 3 3
Insufficient Information 3 3
No Code Available 1 1
Patient Problem/Medical Problem 1 1

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