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

MDR Year MDR Reports MDR Events
2018 3 3
2019 6 6
2021 2 2
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Break 2 2
Loose or Intermittent Connection 2 2
Use of Device Problem 1 1
Defective Device 1 1
Electrical /Electronic Property Problem 1 1
Output Problem 1 1
Protective Measures Problem 1 1
Insufficient Information 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 13 13
Bone Fracture(s) 4 4
Failure of Implant 1 1
Pain 1 1
Rupture 1 1
Hip Fracture 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ossur Americas II Sep-28-2022
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