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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suture, recombinant technology
Definition Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.
Product CodeNWJ
Regulation Number 878.4494
Device Class 2


Premarket Reviews
ManufacturerDecision
TEPHA, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 8 8
2021 1 1
2022 7 7
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 9 9
Difficult to Open or Remove Packaging Material 4 4
Material Integrity Problem 3 3
Detachment of Device or Device Component 3 3
Packaging Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Break 2 2
Fracture 2 2
Melted 2 2
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
No Known Impact Or Consequence To Patient 4 4
Wound Dehiscence 3 3
No Consequences Or Impact To Patient 3 3
No Patient Involvement 1 1

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