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TPLC
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show TPLC since
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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
1736
1736
2024
715
715
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
6790
6790
Material Twisted/Bent
2542
2542
Device-Device Incompatibility
1414
1414
Fracture
1124
1124
Material Deformation
827
827
Naturally Worn
716
716
Dull, Blunt
269
269
Material Fragmentation
267
267
Calibration Problem
249
249
Appropriate Term/Code Not Available
241
241
Material Integrity Problem
225
225
Device Operates Differently Than Expected
220
220
Contamination /Decontamination Problem
203
203
Crack
138
138
Entrapment of Device
128
128
Mechanical Problem
126
126
Mechanical Jam
126
126
Bent
107
107
Detachment of Device or Device Component
102
102
Detachment Of Device Component
90
90
Device Contamination with Chemical or Other Material
84
84
Compatibility Problem
71
71
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
49
49
Fitting Problem
46
46
Peeled/Delaminated
45
45
Adverse Event Without Identified Device or Use Problem
41
41
Unintended Movement
39
39
Packaging Problem
35
35
Loose or Intermittent Connection
35
35
Physical Resistance/Sticking
34
34
Defective Device
31
31
Material Separation
27
32
Device Stops Intermittently
25
25
Sticking
24
24
Material Distortion
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
Illegible Information
12
12
Electrical /Electronic Property Problem
11
11
Improper or Incorrect Procedure or Method
11
11
Failure to Calibrate
10
10
Structural Problem
10
10
Manufacturing, Packaging or Shipping Problem
10
10
Loss of Power
10
10
Noise, Audible
10
10
Torn Material
9
9
Material Split, Cut or Torn
9
9
Device Handling Problem
9
9
Material Disintegration
9
9
Failure to Run on Battery
8
8
Positioning Problem
8
8
Mechanics Altered
7
7
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
Failure to Align
6
6
Device Dislodged or Dislocated
6
6
Activation, Positioning or Separation Problem
6
6
Device Damaged by Another Device
6
6
Residue After Decontamination
5
5
Device Issue
5
5
Failure to Disconnect
5
5
Material Discolored
5
5
Nonstandard Device
5
5
Device Remains Activated
5
5
Shipping Damage or Problem
5
5
Separation Problem
5
5
Incomplete or Inadequate Connection
4
4
Failure to Power Up
4
4
Off-Label Use
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
Output Problem
3
3
Difficult to Advance
3
3
Failure to Cut
3
3
Inadequacy of Device Shape and/or Size
3
3
Failure to Discharge
3
3
Failure To Run On AC/DC
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5829
5834
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
439
439
Device Embedded In Tissue or Plaque
354
354
Foreign Body In Patient
353
353
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
4
4
Spinal Cord Injury
3
3
Local Reaction
3
3
Perforation of Vessels
3
3
Perforation
2
2
Skull Fracture
2
2
Tissue Damage
2
2
Reaction
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
Neck Pain
1
1
Test Result
1
1
Fracture, Arm
1
1
Non-union Bone Fracture
1
1
Impaired Healing
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-28-2024
19
Synthes (USA) Products LLC
II
May-23-2018
20
Trilliant Surgical, LLC
II
Jan-10-2020
21
Wright Medical Technology Inc
II
Sep-22-2010
22
Zimmer Biomet, Inc.
II
Jul-04-2019
23
Zimmer Inc.
II
Jul-06-2011
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