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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthosis, lumbo-sacral
Product CodeIPY
Regulation Number 890.3490
Device Class 1

MDR Year MDR Reports MDR Events
2015 2 2
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Sharp Edges 2 2
Material Frayed 1 1
Device Operates Differently Than Expected 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 2 2
Laceration(s) 2 2
Pain 1 1
Numbness 1 1
Abrasion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ossur H / F II Mar-31-2016
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