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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pin, fixation, smooth, metallic
Regulation Description Smooth or threaded metallic bone fixation fastener.
Product CodeNDL
Regulation Number 888.3040
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2026 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 28 28
Unexpected Therapeutic Results 12 12
Material Rupture 4 4
Device Dislodged or Dislocated 3 3
Inaccurate Information 1 1
Fracture 1 1
Break 1 1
Material Twisted/Bent 1 1
Patient Device Interaction Problem 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 39 39
No Clinical Signs, Symptoms or Conditions 4 4
Nonunion/Delayed-union Bone Fracture 2 2
Subluxation 2 2
Pain 1 1
Failure of Implant 1 1
Joint Laxity 1 1
Malunion of Bone 1 1
Wound Dehiscence 1 1

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