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TPLC
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show TPLC since
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2024
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Device
extractor
Product Code
HWB
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
71
71
2015
78
78
2016
162
162
2017
239
239
2018
287
287
2019
320
320
2020
302
302
2021
322
322
2022
319
319
2023
350
350
2024
49
49
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1286
1286
Device-Device Incompatibility
341
341
Material Twisted/Bent
218
218
Material Deformation
163
163
Naturally Worn
147
147
Fracture
131
131
Mechanical Jam
68
68
Crack
59
59
Appropriate Term/Code Not Available
53
53
Bent
45
45
Material Fragmentation
41
41
Material Integrity Problem
26
26
Device Operates Differently Than Expected
23
23
Scratched Material
19
19
Entrapment of Device
19
19
Mechanical Problem
19
19
Difficult to Remove
19
19
Adverse Event Without Identified Device or Use Problem
18
18
Dull, Blunt
17
17
Physical Resistance/Sticking
15
15
Corroded
14
14
Component Missing
13
13
Loose or Intermittent Connection
12
12
Detachment of Device or Device Component
12
12
Contamination /Decontamination Problem
11
11
Fitting Problem
10
10
Metal Shedding Debris
9
9
Connection Problem
9
9
No Apparent Adverse Event
9
9
Insufficient Information
6
6
Illegible Information
6
6
Device Damaged by Another Device
6
6
Device Slipped
6
6
Device Issue
5
5
Use of Device Problem
5
5
Unintended Movement
5
5
Difficult to Open or Close
4
4
Defective Device
4
4
Structural Problem
4
4
Disassembly
4
4
Difficult to Insert
3
3
Detachment Of Device Component
3
3
Failure to Align
3
3
Device Difficult to Maintain
3
3
Device Handling Problem
2
2
Component or Accessory Incompatibility
2
2
Mechanics Altered
2
2
Sticking
2
2
Peeled/Delaminated
2
2
Device Damaged Prior to Use
2
2
Improper or Incorrect Procedure or Method
1
1
Difficult To Position
1
1
Off-Label Use
1
1
Failure to Advance
1
1
Failure to Cut
1
1
Loss of or Failure to Bond
1
1
Failure To Adhere Or Bond
1
1
Degraded
1
1
Material Discolored
1
1
Disconnection
1
1
Misconnection
1
1
Unintended Collision
1
1
Material Distortion
1
1
Activation, Positioning or Separation Problem
1
1
Device Dislodged or Dislocated
1
1
Device Contamination with Chemical or Other Material
1
1
Human-Device Interface Problem
1
1
Compatibility Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Incomplete or Inadequate Connection
1
1
Activation Problem
1
1
Separation Problem
1
1
Misassembly by Users
1
1
Output Problem
1
1
Positioning Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1008
1008
No Consequences Or Impact To Patient
713
713
No Known Impact Or Consequence To Patient
270
270
No Information
159
159
No Code Available
143
143
No Patient Involvement
71
71
Insufficient Information
68
68
Not Applicable
42
42
Sedation
35
35
Device Embedded In Tissue or Plaque
32
32
Foreign Body In Patient
20
20
Failure of Implant
11
11
Bone Fracture(s)
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Blood Loss
5
5
Injury
4
4
Pain
4
4
Unspecified Infection
3
3
Discomfort
3
3
Non-union Bone Fracture
3
3
Muscle Weakness
2
2
Seroma
2
2
Tissue Damage
2
2
Cerebrospinal Fluid Leakage
2
2
Numbness
2
2
Patient Problem/Medical Problem
2
2
Unspecified Nervous System Problem
2
2
Unspecified Tissue Injury
2
2
Fall
1
1
Arthritis
1
1
Rheumatoid Arthritis
1
1
Joint Dislocation
1
1
Impaired Healing
1
1
Therapeutic Response, Decreased
1
1
Therapeutic Response, Increased
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Encore Medical, Lp
II
Dec-28-2010
2
Stryker Howmedica Osteonics Corp.
II
Apr-27-2010
3
Synthes, Inc.
II
Apr-25-2018
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