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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
2019
1550
1550
2020
1477
1477
2021
2006
2006
2022
2086
2086
2023
2245
2245
2024
931
931
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
7409
7409
Crack
1011
1011
Naturally Worn
830
830
Device-Device Incompatibility
637
637
Fracture
571
571
Material Twisted/Bent
333
333
Scratched Material
186
186
Contamination /Decontamination Problem
182
182
Material Deformation
178
178
Material Integrity Problem
122
122
No Apparent Adverse Event
91
91
Mechanical Jam
73
73
Adverse Event Without Identified Device or Use Problem
67
67
Detachment of Device or Device Component
58
58
Unintended Movement
53
53
Entrapment of Device
36
36
Component Missing
31
31
Illegible Information
31
31
Physical Resistance/Sticking
23
23
Material Discolored
20
20
Failure to Disconnect
19
19
Mechanical Problem
17
17
Loose or Intermittent Connection
16
16
Device Slipped
12
12
Material Fragmentation
12
12
Appropriate Term/Code Not Available
12
12
Device Contamination with Chemical or Other Material
11
11
Manufacturing, Packaging or Shipping Problem
10
10
Difficult to Remove
10
10
Use of Device Problem
8
8
Corroded
8
8
Structural Problem
8
8
Compatibility Problem
6
6
Connection Problem
6
6
Insufficient Information
6
6
Off-Label Use
6
6
Defective Device
5
5
Deformation Due to Compressive Stress
5
5
Improper or Incorrect Procedure or Method
4
4
Fitting Problem
4
4
Device Dislodged or Dislocated
4
4
Positioning Problem
3
3
Material Separation
3
3
Dull, Blunt
3
3
Failure to Cut
2
2
Problem with Sterilization
2
2
Device Damaged Prior to Use
2
2
Flaked
2
2
Material Disintegration
2
2
Degraded
2
2
Separation Problem
2
2
Failure to Clean Adequately
2
2
Device Damaged by Another Device
2
2
Osseointegration Problem
2
2
Mechanics Altered
2
2
Activation, Positioning or Separation Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Missing Information
1
1
Difficult or Delayed Separation
1
1
Therapeutic or Diagnostic Output Failure
1
1
Device Handling Problem
1
1
Missing Test Results
1
1
Noise, Audible
1
1
Patient Device Interaction Problem
1
1
Material Split, Cut or Torn
1
1
Accessory Incompatible
1
1
Device Reprocessing Problem
1
1
Difficult to Insert
1
1
Product Quality Problem
1
1
Device Difficult to Setup or Prepare
1
1
Defective Component
1
1
Unstable
1
1
Solder Joint Fracture
1
1
Residue After Decontamination
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6965
6965
No Consequences Or Impact To Patient
2552
2552
Insufficient Information
526
526
No Code Available
183
183
No Known Impact Or Consequence To Patient
125
125
No Patient Involvement
64
64
Not Applicable
62
62
Foreign Body In Patient
36
36
No Information
13
13
Device Embedded In Tissue or Plaque
6
6
Unspecified Infection
5
5
Pain
5
5
Injury
4
4
Failure of Implant
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Bone Fracture(s)
2
2
Hematoma
1
1
Thrombosis
1
1
Non-union Bone Fracture
1
1
Reaction
1
1
Needle Stick/Puncture
1
1
Patient Problem/Medical Problem
1
1
Inadequate Osseointegration
1
1
Osteopenia/ Osteoporosis
1
1
Unspecified Musculoskeletal problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Enztec Limited
II
Jan-24-2020
2
Exactech, Inc.
II
Jun-30-2023
3
Exactech, Inc.
II
Sep-10-2019
4
XTANT Medical
II
Jul-04-2020
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