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TPLC
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show TPLC since
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2024
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Device
impactor
Product Code
HWA
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2016
857
857
2017
1404
1404
2018
1609
1609
2019
1550
1550
2020
1477
1477
2021
2006
2006
2022
2086
2086
2023
2245
2245
2024
1307
1307
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
10544
10544
Crack
1298
1298
Naturally Worn
943
943
Fracture
827
827
Device-Device Incompatibility
702
702
Material Twisted/Bent
337
337
Material Deformation
213
213
Scratched Material
204
204
Contamination /Decontamination Problem
191
191
Appropriate Term/Code Not Available
164
164
Material Integrity Problem
125
125
No Apparent Adverse Event
106
106
Mechanical Jam
98
98
Detachment of Device or Device Component
74
74
Adverse Event Without Identified Device or Use Problem
72
72
Unintended Movement
62
62
Component Missing
57
57
Loose or Intermittent Connection
52
52
Connection Problem
40
40
Insufficient Information
39
39
Entrapment of Device
38
38
Failure to Disconnect
34
34
Illegible Information
33
33
Material Fragmentation
30
30
Mechanical Problem
28
28
Disassembly
28
28
Physical Resistance/Sticking
24
24
Difficult to Remove
24
24
Device Contamination with Chemical or Other Material
22
22
Material Discolored
21
21
Detachment Of Device Component
16
16
Dull, Blunt
16
16
Device Operates Differently Than Expected
14
14
Device Slipped
14
14
Fitting Problem
13
13
Bent
12
12
Corroded
11
11
Manufacturing, Packaging or Shipping Problem
11
11
Structural Problem
9
9
Use of Device Problem
9
9
Device Damaged by Another Device
8
8
Device Reprocessing Problem
7
7
Device Dislodged or Dislocated
7
7
Compatibility Problem
7
7
Off-Label Use
6
6
Defective Device
6
6
Device Damaged Prior to Use
5
5
Improper or Incorrect Procedure or Method
5
5
Device Issue
5
5
Deformation Due to Compressive Stress
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
7243
7243
No Consequences Or Impact To Patient
4314
4314
No Information
1154
1154
No Known Impact Or Consequence To Patient
963
963
Insufficient Information
641
641
No Code Available
214
214
No Patient Involvement
131
131
Not Applicable
110
110
Foreign Body In Patient
56
56
Device Embedded In Tissue or Plaque
24
24
Pain
8
8
Unspecified Infection
7
7
Injury
6
6
Failure of Implant
4
4
Bone Fracture(s)
3
3
Sedation
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Inadequate Osseointegration
2
2
Reaction
2
2
Patient Problem/Medical Problem
1
1
Limited Mobility Of The Implanted Joint
1
1
Joint Disorder
1
1
Unspecified Musculoskeletal problem
1
1
Hematoma
1
1
Osteopenia/ Osteoporosis
1
1
Ossification
1
1
Foreign Body Reaction
1
1
Oversedation
1
1
Needle Stick/Puncture
1
1
Thrombosis
1
1
Host-Tissue Reaction
1
1
Non-union Bone Fracture
1
1
Tissue Damage
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Encore Medical, Lp
II
Mar-08-2017
2
Enztec Limited
II
Jan-24-2020
3
Exactech, Inc.
II
Jun-30-2023
4
Exactech, Inc.
II
Sep-10-2019
5
Greatbatch Medical
I
Nov-29-2016
6
Stryker Howmedica Osteonics Corp.
II
Oct-07-2016
7
XTANT Medical
II
Jul-04-2020
8
Zimmer Biomet, Inc.
II
Feb-14-2018
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