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TPLC
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show TPLC since
2009
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2011
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2013
2014
2015
2016
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2019
2020
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2024
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Device
passer
Product Code
HWQ
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
10
10
2015
14
14
2016
28
28
2017
39
39
2018
64
64
2019
55
55
2020
171
171
2021
160
160
2022
63
63
2023
60
60
2024
26
26
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
373
373
Material Separation
54
54
Detachment of Device or Device Component
45
45
Mechanical Jam
36
36
Mechanical Problem
19
19
Failure to Advance
18
18
Fracture
16
16
Material Integrity Problem
14
14
Material Fragmentation
14
14
Detachment Of Device Component
13
13
Device Operates Differently Than Expected
13
13
Adverse Event Without Identified Device or Use Problem
12
12
Physical Resistance/Sticking
11
11
Material Deformation
10
10
Insufficient Information
9
9
Device Damaged Prior to Use
7
7
Firing Problem
6
6
Bent
6
6
Device Dislodged or Dislocated
6
6
Material Split, Cut or Torn
5
5
Difficult to Open or Close
5
5
Misassembled
5
5
Device Or Device Fragments Location Unknown
5
5
Activation, Positioning or Separation Problem
4
4
Delivered as Unsterile Product
4
4
No Apparent Adverse Event
4
4
Device Fell
4
4
Ejection Problem
4
4
Positioning Failure
4
4
Component Falling
3
3
Device-Device Incompatibility
3
3
Failure to Fire
3
3
Entrapment of Device
3
3
Nonstandard Device
3
3
Difficult to Remove
3
3
Metal Shedding Debris
3
3
Device Contamination with Chemical or Other Material
2
2
Device Packaging Compromised
2
2
Appropriate Term/Code Not Available
2
2
Failure to Cycle
2
2
Difficult to Insert
2
2
Unsealed Device Packaging
2
2
Separation Failure
2
2
Activation Problem
2
2
Difficult to Open or Remove Packaging Material
2
2
Separation Problem
2
2
Grounding Malfunction
1
1
Migration
1
1
Melted
1
1
Inaccurate Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
329
329
No Known Impact Or Consequence To Patient
225
225
No Consequences Or Impact To Patient
49
49
Foreign Body In Patient
31
31
No Information
29
29
Device Embedded In Tissue or Plaque
23
23
No Patient Involvement
14
14
Insufficient Information
7
7
Injury
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
No Code Available
3
3
Hypersensitivity/Allergic reaction
2
2
Pain
2
2
Tissue Damage
2
2
Unspecified Infection
1
1
Tingling
1
1
Failure of Implant
1
1
Rupture
1
1
Chills
1
1
Loss of Range of Motion
1
1
Numbness
1
1
Scar Tissue
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet, Inc.
II
May-26-2016
2
Biomet, Inc.
II
Dec-23-2015
3
Biomet, Inc.
II
Oct-09-2014
4
Biomet, Inc.
II
Jun-16-2014
5
Linvatec Corp. dba ConMed Linvatec
II
Aug-24-2010
6
Surgical Instrument Service And Savings, Inc.
II
Jul-01-2013
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