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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Product CodeKTZ
Regulation Number 888.4150
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2022 2 2
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 5 5
Break 1 1
Fracture 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
No Consequences Or Impact To Patient 2 2

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