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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, bending or contouring
Product CodeHXP
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2019 4 4
2020 10 10
2021 19 19
2022 11 11
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 26 26
Mechanical Problem 8 8
Device-Device Incompatibility 7 7
Connection Problem 3 3
Corroded 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Crack 1 1
Loose or Intermittent Connection 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38 38
No Consequences Or Impact To Patient 7 7
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 1 1
Not Applicable 1 1
No Code Available 1 1

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