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TPLC
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show TPLC since
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Device
impactor
Product Code
HWA
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2017
1404
1404
2018
1609
1609
2019
1550
1550
2020
1477
1477
2021
2009
2009
2022
835
835
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
6366
6366
Crack
805
805
Fracture
519
519
Device-Device Incompatibility
364
364
Naturally Worn
363
363
Material Twisted/Bent
334
334
Scratched Material
146
146
Material Deformation
136
136
Appropriate Term/Code Not Available
130
130
Contamination /Decontamination Problem
114
114
Adverse Event Without Identified Device or Use Problem
63
63
Component Missing
47
47
Detachment of Device or Device Component
45
45
Loose or Intermittent Connection
43
43
Material Integrity Problem
42
42
Mechanical Jam
42
42
Connection Problem
38
38
Unintended Movement
33
33
Insufficient Information
32
32
Entrapment of Device
24
24
Physical Resistance/Sticking
23
23
Device Contamination with Chemical or Other Material
22
22
Difficult to Remove
19
19
Mechanical Problem
18
18
Dull, Blunt
16
16
Failure to Disconnect
15
15
Material Discolored
15
15
Disassembly
14
14
Material Fragmentation
12
12
Device Slipped
12
12
Use of Device Problem
10
10
Detachment Of Device Component
10
10
No Apparent Adverse Event
9
9
Illegible Information
9
9
Bent
7
7
Device Operates Differently Than Expected
7
7
Device Damaged by Another Device
7
7
Defective Device
6
6
Structural Problem
6
6
Corroded
6
6
Device Reprocessing Problem
6
6
Fitting Problem
6
6
Device Damaged Prior to Use
5
5
Defective Component
4
4
Degraded
4
4
Off-Label Use
4
4
Device Issue
4
4
Compatibility Problem
4
4
Separation Problem
4
4
Positioning Problem
4
4
Material Split, Cut or Torn
3
3
Flaked
3
3
Delivered as Unsterile Product
3
3
Device Difficult to Setup or Prepare
3
3
Difficult to Insert
2
2
Problem with Sterilization
2
2
Sticking
2
2
Material Rupture
2
2
Material Disintegration
2
2
Device Dislodged or Dislocated
2
2
Device Difficult to Maintain
2
2
Failure to Cut
2
2
Deformation Due to Compressive Stress
2
2
Failure to Clean Adequately
2
2
Difficult or Delayed Separation
1
1
Missing Information
1
1
Device Fell
1
1
Missing Test Results
1
1
Explosion
1
1
Delamination
1
1
Device Or Device Fragments Location Unknown
1
1
Blocked Connection
1
1
Separation Failure
1
1
Solder Joint Fracture
1
1
Split
1
1
Loss of Osseointegration
1
1
Osseointegration Problem
1
1
Material Protrusion/Extrusion
1
1
Device Disinfection Or Sterilization Issue
1
1
Fluid Leak
1
1
Failure to Discharge
1
1
Disconnection
1
1
Accessory Incompatible
1
1
Burst Container or Vessel
1
1
Improper or Incorrect Procedure or Method
1
1
Peeled/Delaminated
1
1
Pitted
1
1
Imprecision
1
1
Misconnection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
4231
4231
No Clinical Signs, Symptoms or Conditions
2880
2880
No Information
854
854
No Known Impact Or Consequence To Patient
526
526
No Code Available
206
206
Insufficient Information
146
146
Not Applicable
109
109
No Patient Involvement
105
105
Foreign Body In Patient
38
38
Device Embedded In Tissue or Plaque
13
13
Pain
6
6
Injury
4
4
Unspecified Infection
4
4
Failure of Implant
3
3
Bone Fracture(s)
3
3
Reaction
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Hematoma
1
1
Sedation
1
1
Non-union Bone Fracture
1
1
Joint Disorder
1
1
Thrombosis
1
1
Inadequate Osseointegration
1
1
Patient Problem/Medical Problem
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
Sep-10-2019
4
XTANT Medical
II
Jul-04-2020
5
Zimmer Biomet, Inc.
II
Feb-14-2018
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