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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device appliance, fixation, nail/blade/plate combination, single component
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeKTW
Regulation Number 888.3030
Device Class 2

Device Problems
Adverse Event Without Identified Device or Use Problem 43
Break 32
Migration or Expulsion of Device 12
Fitting Problem 7
Device Operates Differently Than Expected 4
Device-Device Incompatibility 4
Appropriate Term/Code Not Available 3
Unintended Movement 3
Sticking 2
Dull, Blunt 1
Mechanical Jam 1
Device Dislodged or Dislocated 1
Material Deformation 1
Material Twisted / Bent 1
Bent 1
Device Slipped 1
No Apparent Adverse Event 1
Failure to Align 1
Total Device Problems 119


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