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TPLC
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Device
prosthesis, partial ossicular replacement
Product Code
ETB
Regulation Number
874.3450
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
6
6
2020
4
4
2021
1
1
2022
6
6
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
2
2
Material Deformation
2
2
Migration
2
2
Sparking
1
1
Separation Problem
1
1
Break
1
1
Mechanical Problem
1
1
Malposition of Device
1
1
Insufficient Information
1
1
Unsealed Device Packaging
1
1
Shipping Damage or Problem
1
1
Material Twisted/Bent
1
1
Difficult or Delayed Positioning
1
1
Failure to Fire
1
1
Difficult to Open or Close
1
1
Temperature Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
7
7
No Consequences Or Impact To Patient
3
3
Insufficient Information
2
2
Nerve Damage
2
2
No Known Impact Or Consequence To Patient
2
2
No Information
1
1
Partial Hearing Loss
1
1
Pain
1
1
Inadequate Pain Relief
1
1
Skin Tears
1
1
Foreign Body In Patient
1
1
Burn(s)
1
1
Facial Nerve Paralysis
1
1
Granuloma
1
1
Hearing Impairment
1
1
Inflammation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Olympus Corporation of the Americas
II
Aug-14-2020
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