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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 spatula, orthopedic
Regulation Description Manual surgical instrument for general use.
Product CodeHXR
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 1 1
Contamination of Device Ingredient or Reagent 1 1
Break 1 1
Device Expiration Issue 1 1
Migration or Expulsion of Device 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
Failure to Anastomose 1 1
Unspecified Infection 1 1

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