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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, wrist, hemi-, ulnar
Regulation Description Wrist joint ulnar (hemi-wrist) polymer prosthesis.
Product CodeKXE
Regulation Number 888.3810
Device Class 2

MDR Year MDR Reports MDR Events
2016 3 3
2017 5 5
2018 3 3
2019 7 7
2020 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13 13
Insufficient Information 3 3
Fracture 2 2
Migration or Expulsion of Device 2 2
Naturally Worn 1 1
Appropriate Term/Code Not Available 1 1
Break 1 1
Detachment Of Device Component 1 1
Material Erosion 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 6 6
No Code Available 6 6
No Information 4 4
Injury 2 2
Swelling 2 2
Bone Fracture(s) 2 2
Failure of Implant 1 1
Unspecified Infection 1 1
Inflammation 1 1
Nerve Damage 1 1
Neuropathy 1 1
Discomfort 1 1
Rash 1 1
Post Operative Wound Infection 1 1
Sleep Dysfunction 1 1
Fall 1 1

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