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TPLC
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show TPLC since
2009
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2014
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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
2016
990
990
2017
1369
1369
2018
1468
1468
2019
2011
2011
2020
1644
1644
2021
2000
2000
2022
1721
1726
2023
1735
1735
2024
294
294
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
5585
5585
Material Twisted/Bent
2397
2397
Device-Device Incompatibility
1332
1332
Fracture
1004
1004
Material Deformation
723
723
Naturally Worn
689
689
Calibration Problem
247
247
Dull, Blunt
240
240
Material Integrity Problem
220
220
Appropriate Term/Code Not Available
215
215
Material Fragmentation
215
215
Contamination /Decontamination Problem
195
195
Crack
128
128
Entrapment of Device
123
123
Mechanical Problem
104
104
Mechanical Jam
104
104
Device Operates Differently Than Expected
98
98
Bent
87
87
Detachment of Device or Device Component
78
78
Device Contamination with Chemical or Other Material
72
72
Compatibility Problem
67
67
Connection Problem
65
65
Use of Device Problem
47
47
Peeled/Delaminated
41
41
Detachment Of Device Component
41
41
Component Missing
40
40
Difficult to Remove
38
38
Failure To Adhere Or Bond
36
36
Packaging Problem
35
35
Unintended Movement
34
34
Physical Resistance/Sticking
34
34
Fitting Problem
32
32
Loose or Intermittent Connection
31
31
Adverse Event Without Identified Device or Use Problem
31
31
Device Slipped
30
30
Material Separation
22
27
No Apparent Adverse Event
21
21
Delivered as Unsterile Product
19
19
Defective Device
18
18
Insufficient Information
17
17
Scratched Material
15
15
Material Distortion
15
15
Corroded
15
15
Disassembly
15
15
Device Damaged Prior to Use
12
12
Illegible Information
11
11
Failure to Calibrate
10
10
Material Disintegration
9
9
Material Split, Cut or Torn
9
9
Manufacturing, Packaging or Shipping Problem
8
8
Improper or Incorrect Procedure or Method
8
8
Electrical /Electronic Property Problem
8
8
Structural Problem
8
8
Sticking
7
7
Device Inoperable
7
7
Device Reprocessing Problem
7
7
Device Difficult to Maintain
7
7
Noise, Audible
6
6
Activation, Positioning or Separation Problem
6
6
Degraded
6
6
Failure to Align
5
5
Defective Component
5
5
Mechanics Altered
5
5
Device Damaged by Another Device
5
5
Device Handling Problem
5
5
Separation Problem
5
5
Incomplete or Inadequate Connection
4
4
Device Dislodged or Dislocated
4
4
Deformation Due to Compressive Stress
4
4
Device Issue
4
4
Unsealed Device Packaging
4
4
Nonstandard Device
3
3
Inadequacy of Device Shape and/or Size
3
3
Failure to Discharge
3
3
Material Discolored
3
3
Difficult to Insert
3
3
Failure to Cut
3
3
Failure to Disconnect
3
3
Device Markings/Labelling Problem
3
3
Device Sensing Problem
2
2
Separation Failure
2
2
Device Operational Issue
2
2
Device Fell
2
2
Premature Separation
2
2
Therapeutic or Diagnostic Output Failure
2
2
Output Problem
2
2
Positioning Problem
2
2
Power Problem
2
2
Labelling, Instructions for Use or Training Problem
2
2
Fluid/Blood Leak
2
2
Output above Specifications
2
2
Misassembled
2
2
Positioning Failure
2
2
Component Falling
2
2
Component Incompatible
2
2
Calibration Error
2
2
Unstable
2
2
Solder Joint Fracture
2
2
Microbial Contamination of Device
2
2
Dent in Material
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5470
5475
No Consequences Or Impact To Patient
2731
2731
No Known Impact Or Consequence To Patient
2153
2153
No Patient Involvement
1200
1200
No Information
479
479
No Code Available
383
383
Insufficient Information
375
375
Foreign Body In Patient
335
335
Device Embedded In Tissue or Plaque
220
220
Not Applicable
192
192
Injury
32
32
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
22
22
Patient Problem/Medical Problem
19
19
Failure of Implant
14
14
Unspecified Tissue Injury
9
9
Sedation
6
6
Hemorrhage/Bleeding
5
5
Blood Loss
5
5
Pain
4
4
Local Reaction
3
3
Bone Fracture(s)
3
3
Perforation of Vessels
3
3
Skull Fracture
2
2
Laceration(s)
2
2
Spinal Cord Injury
2
2
Exsanguination
2
2
Unspecified Infection
2
2
Nerve Damage
1
1
Paralysis
1
1
Dysphagia/ Odynophagia
1
1
Irritation
1
1
Skin Inflammation/ Irritation
1
1
Joint Laxity
1
1
Non-union Bone Fracture
1
1
Death
1
1
Foreign Body Reaction
1
1
Tissue Damage
1
1
Impaired Healing
1
1
Ossification
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
Greatbatch Medical
II
Jun-01-2016
4
Orthofix, Inc
II
Jun-01-2016
5
Synthes (USA) Products LLC
II
May-23-2018
6
Trilliant Surgical, LLC
II
Jan-10-2020
7
Zimmer Biomet, Inc.
II
Jul-04-2019
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