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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
2020 9 9
2021 18 18
2022 11 11
2023 6 6
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 25 25
Fracture 9 9
Material Fragmentation 8 8
Entrapment of Device 5 5
Device Slipped 2 2
Device-Device Incompatibility 2 2
Material Integrity Problem 2 2
Compatibility Problem 1 1
Material Split, Cut or Torn 1 1
Migration or Expulsion of Device 1 1
Positioning Problem 1 1
Difficult to Remove 1 1
Component Missing 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30 30
Foreign Body In Patient 12 12
Device Embedded In Tissue or Plaque 5 5
Insufficient Information 3 3
No Known Impact Or Consequence To Patient 2 2
No Patient Involvement 2 2
No Consequences Or Impact To Patient 2 2
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Dec-23-2024
2 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
3 Sklar Instruments II Jan-16-2025
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