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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device instrument, surgical, orthopedic, dc-powered motor and accessory/attachment
Product CodeKIJ
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2022 4 4
2023 6 6
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 10 10
Unintended Movement 4 4
Device Dislodged or Dislocated 2 2
Break 2 2
Entrapment of Device 1 1
Device Fell 1 1
Failure to Clean Adequately 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 1 1
Foreign Body In Patient 1 1

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