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
screwdriver
Product Code
HXX
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
2011
2011
2020
1644
1644
2021
2000
2000
2022
1721
1726
2023
1736
1736
2024
1152
1152
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3855
3855
Material Twisted/Bent
2465
2465
Device-Device Incompatibility
1419
1419
Fracture
808
808
Material Deformation
605
605
Naturally Worn
563
563
Calibration Problem
251
251
Material Integrity Problem
221
221
Contamination /Decontamination Problem
187
187
Entrapment of Device
122
122
Crack
95
95
Mechanical Jam
94
94
Mechanical Problem
87
87
Detachment of Device or Device Component
73
73
Compatibility Problem
69
69
Material Fragmentation
60
60
Connection Problem
55
55
Appropriate Term/Code Not Available
44
44
Use of Device Problem
43
43
Unintended Movement
38
38
Packaging Problem
34
34
Physical Resistance/Sticking
32
32
Component Missing
27
27
No Apparent Adverse Event
26
26
Adverse Event Without Identified Device or Use Problem
26
26
Defective Device
25
25
Device Slipped
22
22
Device Contamination with Chemical or Other Material
20
20
Delivered as Unsterile Product
19
19
Material Separation
17
22
Scratched Material
16
16
Difficult to Remove
16
16
Illegible Information
14
14
Corroded
14
14
Loose or Intermittent Connection
13
13
Dull, Blunt
10
10
Failure to Calibrate
9
9
Device Difficult to Setup or Prepare
9
9
Device Damaged Prior to Use
9
9
Electrical /Electronic Property Problem
8
8
Structural Problem
7
7
Material Disintegration
7
7
Degraded
7
7
Noise, Audible
7
7
Fitting Problem
7
7
Device Difficult to Maintain
6
6
Material Split, Cut or Torn
6
6
Manufacturing, Packaging or Shipping Problem
6
6
Device Reprocessing Problem
6
6
Device Handling Problem
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6208
6213
No Consequences Or Impact To Patient
1837
1837
No Patient Involvement
686
686
No Known Impact Or Consequence To Patient
506
506
Insufficient Information
491
491
Foreign Body In Patient
263
263
No Code Available
200
200
Device Embedded In Tissue or Plaque
94
94
Not Applicable
87
87
No Information
79
79
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
22
22
Injury
21
21
Failure of Implant
9
9
Unspecified Tissue Injury
9
9
Patient Problem/Medical Problem
8
8
Hemorrhage/Bleeding
5
5
Pain
4
4
Blood Loss
3
3
Perforation of Vessels
3
3
Skull Fracture
2
2
Bone Fracture(s)
2
2
Exsanguination
2
2
Perforation
2
2
Spinal Cord Injury
2
2
Impaired Healing
1
1
Unspecified Infection
1
1
Skin Inflammation/ Irritation
1
1
Ossification
1
1
Paralysis
1
1
Nerve Damage
1
1
Laceration(s)
1
1
Joint Laxity
1
1
Tissue Damage
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aesculap Implant Systems LLC
II
Jul-19-2022
2
Flower Orthopedics Corporation
II
Jun-01-2021
3
Synthes (USA) Products LLC
II
May-28-2024
4
Trilliant Surgical, LLC
II
Jan-10-2020
5
Zimmer Biomet, Inc.
II
Jul-04-2019
-
-