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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device curette
Regulation Description Manual surgical instrument for general use.
Product CodeHTF
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2021 16 16
2022 8 8
2023 8 8
2024 8 8
2025 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Break 32 32
Material Integrity Problem 8 8
Fracture 6 6
Mechanical Problem 3 3
Packaging Problem 2 2
Contamination /Decontamination Problem 2 2
Crack 2 2
Unsealed Device Packaging 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Deformation 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Defective Device 1 1
Detachment of Device or Device Component 1 1
Material Separation 1 1
Entrapment of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 51 51
Insufficient Information 6 6
Spinal Column Injury 1 1
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 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
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