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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device wire, surgical
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeLRN
Regulation Number 888.3030
Device Class 2


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 38
Material fragmentation 13
No Known Device Problem 11
Unknown (for use when the device problem is not known) 3
Migration of device or device component 3
Overheating of device or device component 2
Component(s), broken 2
Explanted 2
Fracture 2
Sticking 2
Mechanical jam 2
No code available 1
Bent 1
Mechanical issue 1
Wire(s), breakage of 1
Malfunction 1
Defective item 1
Difficult to open or close 1
Cable break 1
Peeled 1
Device, or device fragments remain in patient 1
Total Device Problems 90

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