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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device screw, fixation, bone, non-spinal, metallic
Regulation Description Smooth or threaded metallic bone fixation fastener.
Product CodeNDJ
Regulation Number 888.3040
Device Class 2

MDR Year MDR Reports MDR Events
2020 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Loss of Osseointegration 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 7 7
Unspecified Infection 3 3
Pain 3 3
No Consequences Or Impact To Patient 1 1
Adhesion(s) 1 1
Sepsis 1 1
Inadequate Osseointegration 1 1

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