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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device assembly, knee/shank/ankle/foot, external
Product CodeISW
Regulation Number 890.3500
Device Class 2

MDR Year MDR Reports MDR Events
2019 6 6
2021 2 2
2022 2 2
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Insufficient Information 3 3
Break 2 2
Loose or Intermittent Connection 1 1
Defective Device 1 1
Inadequate User Interface 1 1
Naturally Worn 1 1
Physical Resistance/Sticking 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 10 10
Bone Fracture(s) 4 4
Pain 1 1
Rupture 1 1
Hip Fracture 1 1
Limb Fracture 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ossur Americas II Sep-28-2022
2 Ossur H / F II May-10-2024
3 Ossur H / F II Jan-25-2024
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