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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
Product CodeKXE
Regulation Number 888.3810
Device Class 2


Premarket Reviews
ManufacturerDecision
APTIS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 7 7
2020 5 5
2021 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 12 12
Installation-Related Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 5 5
Pain 4 4
Injury 2 2
Joint Dislocation 2 2
Post Operative Wound Infection 1 1
Inflammation 1 1
Nerve Damage 1 1
Neuropathy 1 1

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