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TPLC
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show TPLC since
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2024
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Device
assembly, knee/shank/ankle/foot, external
Product Code
ISW
Regulation Number
890.3500
Device Class
2
MDR Year
MDR Reports
MDR Events
2016
10
10
2017
4
4
2018
3
3
2019
6
6
2021
2
2
2022
2
2
2023
1
1
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
7
7
Device Operates Differently Than Expected
7
7
Insufficient Information
4
4
Loose or Intermittent Connection
3
3
Break
3
3
Improper or Incorrect Procedure or Method
1
1
Deformation Due to Compressive Stress
1
1
Electrical /Electronic Property Problem
1
1
Naturally Worn
1
1
Output Problem
1
1
Physical Resistance/Sticking
1
1
Unintended Movement
1
1
Defective Device
1
1
Human Factors Issue
1
1
Material Twisted/Bent
1
1
Use of Device Problem
1
1
Fracture
1
1
Protective Measures Problem
1
1
Inadequate User Interface
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Fall
21
21
Bone Fracture(s)
6
6
Hip Fracture
3
3
No Consequences Or Impact To Patient
3
3
Damage to Ligament(s)
2
2
Rupture
2
2
Limb Fracture
2
2
Failure of Implant
1
1
Head Injury
1
1
Contusion
1
1
Injury
1
1
Burn(s)
1
1
Concussion
1
1
Laceration(s)
1
1
Pain
1
1
Unspecified Tissue Injury
1
1
Bruise/Contusion
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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