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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, tendon, passive
Product CodeHXA
Regulation Number 888.3025
Device Class 2

MDR Year MDR Reports MDR Events
2014 1 1
2016 1 1
2018 1 1
2019 3 3
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Packaging Problem 1 1
Device Expiration Issue 1 1
Device Disinfection Or Sterilization Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 2 2
No Known Impact Or Consequence To Patient 2 2
Nerve Damage 2 2
No Code Available 1 1
No Patient Involvement 1 1
Pain 1 1

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