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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device wire, surgical
Product CodeLRN
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
T. KOROS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 17
No Known Device Problem 10
Material fragmentation 5
Unknown (for use when the device problem is not known) 3
Migration of device or device component 3
Fracture 2
Explanted 2
Mechanical jam 2
Sticking 2
Component(s), broken 2
Mechanical issue 1
Defective item 1
Malfunction 1
Peeled 1
Cable break 1
Wire(s), breakage of 1
Difficult to open or close 1
No code available 1
Bent 1
Device, or device fragments remain in patient 1
Total Device Problems 58

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