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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
Product CodeGDG
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 9 9
2021 18 18
2022 11 11
2023 6 6
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 25 25
Fracture 10 10
Material Fragmentation 7 7
Entrapment of Device 4 4
Material Integrity Problem 2 2
Device Slipped 2 2
Component Missing 1 1
Detachment of Device or Device Component 1 1
Device-Device Incompatibility 1 1
Compatibility Problem 1 1
Migration or Expulsion of Device 1 1
Difficult to Remove 1 1
Material Separation 1 1
Positioning Problem 1 1
Material Split, Cut or Torn 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 22
Foreign Body In Patient 11 11
Device Embedded In Tissue or Plaque 6 6
No Known Impact Or Consequence To Patient 5 5
Insufficient Information 3 3
No Consequences Or Impact To Patient 3 3
No Patient Involvement 2 2
Patient Problem/Medical Problem 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
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