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TPLC
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Device
prosthesis, partial ossicular replacement
Regulation Description
Partial ossicular replacement prosthesis.
Product Code
ETB
Regulation Number
874.3450
Device Class
2
Premarket Reviews
Manufacturer
Decision
MED-EL ELEKTROMEDIZINISCHE GERÄTE GMBH
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2020
4
4
2021
1
1
2022
6
6
2023
1
1
2024
3
3
2025
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Migration
2
2
Shipping Damage or Problem
2
2
Material Deformation
2
2
Insufficient Information
1
1
Material Twisted/Bent
1
1
Difficult to Open or Close
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Separation Problem
1
1
Temperature Problem
1
1
Sparking
1
1
Mechanical Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
9
9
Insufficient Information
3
3
Inadequate Pain Relief
1
1
Hearing Impairment
1
1
Inflammation
1
1
Foreign Body In Patient
1
1
No Known Impact Or Consequence To Patient
1
1
Partial Hearing Loss
1
1
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Olympus Corporation of the Americas
II
Aug-14-2020
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