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TPLC
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show TPLC since
2009
2010
2011
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2013
2014
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2016
2017
2018
2019
2020
2021
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2024
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Device
screwdriver
Product Code
HXX
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2017
1369
1369
2018
1468
1468
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
5314
5314
Material Twisted/Bent
2623
2623
Device-Device Incompatibility
1477
1477
Fracture
1001
1001
Material Deformation
758
758
Naturally Worn
688
688
Calibration Problem
253
253
Material Integrity Problem
237
237
Contamination /Decontamination Problem
216
216
Dull, Blunt
202
202
Appropriate Term/Code Not Available
194
194
Material Fragmentation
133
133
Entrapment of Device
132
132
Crack
129
129
Mechanical Jam
107
107
Mechanical Problem
106
106
Detachment of Device or Device Component
81
81
Device Contamination with Chemical or Other Material
73
73
Compatibility Problem
69
69
Connection Problem
63
63
Bent
61
61
Device Operates Differently Than Expected
52
52
Use of Device Problem
47
47
Peeled/Delaminated
39
39
Unintended Movement
39
39
Physical Resistance/Sticking
35
35
Packaging Problem
35
35
Component Missing
34
34
Difficult to Remove
33
33
Adverse Event Without Identified Device or Use Problem
31
31
Device Slipped
28
28
Defective Device
26
26
No Apparent Adverse Event
26
26
Loose or Intermittent Connection
25
25
Failure To Adhere Or Bond
24
24
Detachment Of Device Component
21
21
Fitting Problem
20
20
Delivered as Unsterile Product
19
19
Material Separation
18
23
Scratched Material
17
17
Corroded
16
16
Insufficient Information
15
15
Illegible Information
14
14
Disassembly
13
13
Device Damaged Prior to Use
12
12
Structural Problem
10
10
Material Split, Cut or Torn
9
9
Device Difficult to Setup or Prepare
9
9
Material Disintegration
9
9
Failure to Calibrate
9
9
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6212
6217
No Consequences Or Impact To Patient
2698
2698
No Known Impact Or Consequence To Patient
1512
1512
No Patient Involvement
1083
1083
Insufficient Information
491
491
No Information
360
360
No Code Available
353
353
Foreign Body In Patient
335
335
Not Applicable
191
191
Device Embedded In Tissue or Plaque
174
174
Injury
31
31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
22
22
Patient Problem/Medical Problem
17
17
Failure of Implant
14
14
Unspecified Tissue Injury
9
9
Blood Loss
5
5
Hemorrhage/Bleeding
5
5
Pain
4
4
Bone Fracture(s)
3
3
Local Reaction
3
3
Sedation
3
3
Perforation of Vessels
3
3
Unspecified Infection
2
2
Skull Fracture
2
2
Exsanguination
2
2
Perforation
2
2
Laceration(s)
2
2
Spinal Cord Injury
2
2
Impaired Healing
1
1
Skin Inflammation/ Irritation
1
1
Foreign Body Reaction
1
1
Ossification
1
1
Irritation
1
1
Paralysis
1
1
Nerve Damage
1
1
Non-union Bone Fracture
1
1
Dysphagia/ Odynophagia
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
Synthes (USA) Products LLC
II
May-23-2018
5
Trilliant Surgical, LLC
II
Jan-10-2020
6
Zimmer Biomet, Inc.
II
Jul-04-2019
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