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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device septal stapler/absorbable staples
Definition To approximate soft tissues by means of absorbable staples delivered via a pre-loaded stapler delivery system for use during nasal septal surgery, with or without cartilage reinserted. To connect internal nasal tissues to aid healing during nasal septum reconstruction.
Product CodeOLL
Regulation Number 878.4750
Device Class 2

MDR Year MDR Reports MDR Events
2019 2 2
2020 1 1
2022 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Break 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Adhesion(s) 1 1
Inflammation 1 1
Foreign Body In Patient 1 1
Insufficient Information 1 1
Eye Injury 1 1
Nasal Obstruction 1 1

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