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
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
extractor
Regulation Description
Orthopedic manual surgical instrument.
Product Code
HWB
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
302
302
2021
322
322
2022
319
319
2023
350
350
2024
286
286
2025
105
105
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
770
770
Device-Device Incompatibility
365
365
Material Deformation
178
178
Material Twisted/Bent
161
161
Naturally Worn
134
134
Fracture
75
75
Mechanical Jam
59
59
Crack
53
53
Material Integrity Problem
30
30
No Apparent Adverse Event
19
19
Mechanical Problem
16
16
Entrapment of Device
12
12
Contamination /Decontamination Problem
12
12
Scratched Material
11
11
Detachment of Device or Device Component
9
9
Corroded
8
8
Appropriate Term/Code Not Available
8
8
Illegible Information
8
8
Physical Resistance/Sticking
7
7
Device Slipped
7
7
Difficult to Remove
6
6
Use of Device Problem
6
6
Adverse Event Without Identified Device or Use Problem
6
6
Difficult to Open or Close
6
6
Structural Problem
5
5
Defective Device
5
5
Unintended Movement
4
4
Material Fragmentation
3
3
Component Missing
3
3
Failure to Cut
3
3
Loose or Intermittent Connection
3
3
Device Damaged by Another Device
2
2
Mechanics Altered
2
2
Off-Label Use
2
2
Dull, Blunt
2
2
Degraded
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Device Difficult to Maintain
1
1
Device Handling Problem
1
1
Device Damaged Prior to Use
1
1
Activation Problem
1
1
Output Problem
1
1
Activation, Positioning or Separation Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Unintended Collision
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1246
1246
No Consequences Or Impact To Patient
216
216
Insufficient Information
188
188
No Code Available
52
52
Foreign Body In Patient
13
13
Not Applicable
9
9
No Patient Involvement
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
No Known Impact Or Consequence To Patient
7
7
Failure of Implant
6
6
Bone Fracture(s)
5
5
Pain
3
3
Unspecified Tissue Injury
3
3
Unspecified Infection
2
2
Muscle Weakness
2
2
Unspecified Nervous System Problem
2
2
Seroma
2
2
Injury
2
2
Numbness
2
2
Cerebrospinal Fluid Leakage
2
2
Rheumatoid Arthritis
1
1
Discomfort
1
1
Device Embedded In Tissue or Plaque
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Innomed, Inc.
II
May-01-2024
-
-