Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
replacement, ossicular prosthesis, total
Product Code
ETA
Regulation Number
874.3495
Device Class
2
Premarket Reviews
Manufacturer
Decision
AUDIO TECHNOLOGIES S.R.L.
SUBSTANTIALLY EQUIVALENT
1
GRACE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
6
6
2015
5
5
2016
12
12
2017
9
9
2019
9
9
2020
1
1
2022
4
4
2023
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
13
13
Material Fragmentation
9
9
Adverse Event Without Identified Device or Use Problem
8
8
Extrusion
5
5
Material Separation
4
4
Unexpected Therapeutic Results
3
3
Loose or Intermittent Connection
3
3
Detachment of Device or Device Component
2
2
Device Operates Differently Than Expected
1
1
Device Dislodged or Dislocated
1
1
Inadequacy of Device Shape and/or Size
1
1
Use of Device Problem
1
1
Fitting Problem
1
1
Device Damaged Prior to Use
1
1
Component Missing
1
1
Migration or Expulsion of Device
1
1
Device remains implanted
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Material Disintegration
1
1
Entrapment of Device
1
1
Fracture
1
1
Packaging Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Failure of Implant
14
14
No Consequences Or Impact To Patient
12
12
No Known Impact Or Consequence To Patient
7
7
Hearing Loss
6
6
No Clinical Signs, Symptoms or Conditions
5
5
Hearing Impairment
2
2
Erosion
2
2
Perforation
2
2
Therapeutic Response, Decreased
2
2
Impaired Healing
1
1
Foreign Body In Patient
1
1
Device Embedded In Tissue or Plaque
1
1
No Code Available
1
1
Unspecified Ear or Labyrinth Problem
1
1
Implant Pain
1
1
Therapeutic Effects, Unexpected
1
1
Vertigo
1
1
Dizziness
1
1
Bone Fracture(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Heinz Kurz GmbH Medizintechnik
II
Jun-30-2011
2
Medtronic Xomed, Inc.
II
Sep-26-2013
-
-