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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device drills, burrs, trephines and accessories (simple powered), reprocessed
Definition Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Product CodeNLN
Regulation Number 882.4310
Device Class 2

MDR Year MDR Reports MDR Events
2015 1 1
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Thermal Decomposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 2 2
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

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