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TPLC
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show TPLC since
2009
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2011
2012
2013
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
2014
793
793
2015
881
881
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
6618
6618
Material Twisted/Bent
2412
2412
Device-Device Incompatibility
1332
1332
Fracture
1074
1074
Material Deformation
794
794
Naturally Worn
712
712
Dull, Blunt
269
269
Material Fragmentation
267
267
Calibration Problem
247
247
Appropriate Term/Code Not Available
230
230
Material Integrity Problem
221
221
Device Operates Differently Than Expected
220
220
Contamination /Decontamination Problem
196
196
Crack
133
133
Entrapment of Device
127
127
Mechanical Problem
123
123
Mechanical Jam
122
122
Bent
107
107
Detachment of Device or Device Component
99
99
Detachment Of Device Component
90
90
Device Contamination with Chemical or Other Material
84
84
Compatibility Problem
70
70
Connection Problem
66
66
Failure To Adhere Or Bond
64
64
Difficult to Remove
54
54
Device Slipped
52
52
Component Missing
51
51
Use of Device Problem
48
48
Fitting Problem
46
46
Peeled/Delaminated
45
45
Adverse Event Without Identified Device or Use Problem
41
41
Unintended Movement
37
37
Packaging Problem
35
35
Loose or Intermittent Connection
35
35
Physical Resistance/Sticking
34
34
Material Separation
27
32
Device Stops Intermittently
25
25
Sticking
24
24
Material Distortion
23
23
Defective Device
23
23
Failure to Shut Off
21
21
No Apparent Adverse Event
21
21
Device Inoperable
20
20
Continuous Firing
20
20
Delivered as Unsterile Product
19
19
Insufficient Information
19
19
Corroded
18
18
Device Or Device Fragments Location Unknown
18
18
Device Damaged Prior to Use
17
17
Disassembly
16
16
Scratched Material
15
15
Improper or Incorrect Procedure or Method
11
11
Electrical /Electronic Property Problem
11
11
Illegible Information
11
11
Noise, Audible
10
10
Loss of Power
10
10
Failure to Calibrate
10
10
Manufacturing, Packaging or Shipping Problem
10
10
Material Disintegration
9
9
Material Split, Cut or Torn
9
9
Device Handling Problem
9
9
Torn Material
9
9
Failure to Run on Battery
8
8
Positioning Problem
8
8
Structural Problem
8
8
Defective Component
7
7
Separation Failure
7
7
Degraded
7
7
Device Reprocessing Problem
7
7
Device Difficult to Maintain
7
7
Component Falling
6
6
Activation, Positioning or Separation Problem
6
6
Failure to Align
6
6
Mechanics Altered
6
6
Device Dislodged or Dislocated
6
6
Device Damaged by Another Device
6
6
Residue After Decontamination
5
5
Device Issue
5
5
Failure to Disconnect
5
5
Shipping Damage or Problem
5
5
Device Remains Activated
5
5
Separation Problem
5
5
Incomplete or Inadequate Connection
4
4
Failure to Power Up
4
4
Nonstandard Device
4
4
Unsealed Device Packaging
4
4
Difficult to Insert
4
4
Deformation Due to Compressive Stress
4
4
Device Operational Issue
4
4
Device Markings/Labelling Problem
4
4
Power Problem
4
4
Material Torqued
3
3
Difficult to Advance
3
3
Failure to Cut
3
3
Failure to Discharge
3
3
Material Discolored
3
3
Failure To Run On AC/DC
3
3
Overheating of Device
3
3
Inadequacy of Device Shape and/or Size
3
3
Output Problem
3
3
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
3045
3045
No Known Impact Or Consequence To Patient
2963
2963
No Patient Involvement
1437
1437
No Information
548
548
No Code Available
456
456
Insufficient Information
375
375
Device Embedded In Tissue or Plaque
354
354
Foreign Body In Patient
348
348
Not Applicable
192
192
Sedation
53
53
Injury
34
34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
22
22
Patient Problem/Medical Problem
19
19
Failure of Implant
15
15
Blood Loss
9
9
Unspecified Tissue Injury
9
9
Pain
6
6
Hemorrhage/Bleeding
6
6
Bone Fracture(s)
4
4
Laceration(s)
4
4
Unspecified Infection
3
3
Spinal Cord Injury
3
3
Local Reaction
3
3
Perforation of Vessels
3
3
Reaction
2
2
Skull Fracture
2
2
Tissue Damage
2
2
Exsanguination
2
2
Fall
1
1
Foreign Body Reaction
1
1
Ossification
1
1
Arthritis
1
1
Erosion
1
1
Burn(s)
1
1
Death
1
1
Dysphagia/ Odynophagia
1
1
Emotional Changes
1
1
Infiltration into Tissue
1
1
Irritation
1
1
Nerve Damage
1
1
Paralysis
1
1
Fracture, Arm
1
1
Non-union Bone Fracture
1
1
Impaired Healing
1
1
Neck Pain
1
1
Test Result
1
1
Missing Value Reason
1
1
Joint Laxity
1
1
Skin Inflammation/ Irritation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aesculap Implant Systems LLC
II
Jul-19-2022
2
Ascension Orthopedics, Inc
II
Jun-26-2009
3
Biomet, Inc.
II
Sep-28-2012
4
Ebi, Llc
II
Jun-17-2014
5
Ebi, Llc
II
Nov-27-2013
6
Ebi, Llc
II
Mar-15-2013
7
Ebi, Llc
II
Dec-17-2012
8
Flower Orthopedics Corporation
II
Jun-01-2021
9
Greatbatch Medical
II
Jun-01-2016
10
Interventional Spine Inc
II
Oct-13-2011
11
Medtronic Sofamor Danek USA Inc
II
Jan-30-2014
12
Medtronic Sofamor Danek USA Inc
II
Sep-14-2013
13
Orthofix, Inc
II
Jun-01-2016
14
SpineFrontier, Inc.
II
Aug-13-2013
15
SpineFrontier, Inc.
II
Aug-08-2013
16
SpineFrontier, Inc.
II
Aug-08-2013
17
SpineFrontier, Inc.
II
Jul-05-2013
18
Synthes (USA) Products LLC
II
May-23-2018
19
Trilliant Surgical, LLC
II
Jan-10-2020
20
Wright Medical Technology Inc
II
Sep-22-2010
21
Zimmer Biomet, Inc.
II
Jul-04-2019
22
Zimmer Inc.
II
Jul-06-2011
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