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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device trephine
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWK
Regulation Number 888.4540
Device Class 1

Device Problems
Break 39
Entrapment of Device 4
Fracture 1
Material Fragmentation 1
Device-Device Incompatibility 1
Adverse Event Without Identified Device or Use Problem 1
Material Deformation 1
Material Twisted / Bent 1
Total Device Problems 49


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