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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device valve, prosthesis
Product CodeISP
Regulation Number 890.3420
Device Class 1

MDR Year MDR Reports MDR Events
2016 1 1
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Loose or Intermittent Connection 1 1
Device Difficult to Setup or Prepare 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 1 1
Bone Fracture(s) 1 1
Joint Dislocation 1 1
Collapse 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ossur Engineering, Inc II Sep-04-2009
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