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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
2018
1609
1609
2019
1550
1550
2020
1477
1477
2021
2006
2006
2022
2088
2088
2023
1557
1557
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
7370
7370
Crack
997
997
Naturally Worn
666
666
Fracture
586
586
Device-Device Incompatibility
550
550
Material Twisted/Bent
336
336
Material Deformation
176
176
Scratched Material
174
174
Contamination /Decontamination Problem
146
146
Material Integrity Problem
104
104
Adverse Event Without Identified Device or Use Problem
71
71
Mechanical Jam
70
70
No Apparent Adverse Event
67
67
Appropriate Term/Code Not Available
55
55
Detachment of Device or Device Component
52
52
Unintended Movement
46
46
Component Missing
38
38
Loose or Intermittent Connection
37
37
Entrapment of Device
32
32
Illegible Information
25
25
Physical Resistance/Sticking
24
24
Device Contamination with Chemical or Other Material
21
21
Material Discolored
20
20
Failure to Disconnect
19
19
Connection Problem
19
19
Mechanical Problem
16
16
Device Slipped
12
12
Dull, Blunt
12
12
Difficult to Remove
11
11
Use of Device Problem
9
9
Insufficient Information
8
8
Structural Problem
7
7
Material Fragmentation
7
7
Corroded
6
6
Off-Label Use
6
6
Device Damaged by Another Device
6
6
Compatibility Problem
6
6
Device Dislodged or Dislocated
5
5
Defective Device
5
5
Deformation Due to Compressive Stress
5
5
Fitting Problem
5
5
Disassembly
5
5
Device Reprocessing Problem
5
5
Flaked
4
4
Defective Component
4
4
Device Issue
4
4
Material Split, Cut or Torn
4
4
Separation Problem
4
4
Positioning Problem
3
3
Device Damaged Prior to Use
3
3
Delivered as Unsterile Product
3
3
Degraded
3
3
Bent
3
3
Detachment Of Device Component
2
2
Difficult to Insert
2
2
Material Rupture
2
2
Material Disintegration
2
2
Improper or Incorrect Procedure or Method
2
2
Problem with Sterilization
2
2
Failure to Cut
2
2
Device Difficult to Maintain
2
2
Osseointegration Problem
2
2
Failure to Clean Adequately
2
2
Difficult or Delayed Separation
1
1
Missing Information
1
1
Device Fell
1
1
Device Handling Problem
1
1
Missing Test Results
1
1
Patient Device Interaction Problem
1
1
Explosion
1
1
Therapeutic or Diagnostic Output Failure
1
1
Material Protrusion/Extrusion
1
1
Device Or Device Fragments Location Unknown
1
1
Blocked Connection
1
1
Activation, Positioning or Separation Problem
1
1
Separation Failure
1
1
Loss of Osseointegration
1
1
Solder Joint Fracture
1
1
Residue After Decontamination
1
1
Material Separation
1
1
Product Quality Problem
1
1
Peeled/Delaminated
1
1
Device Difficult to Setup or Prepare
1
1
Disconnection
1
1
Accessory Incompatible
1
1
Burst Container or Vessel
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5561
5561
No Consequences Or Impact To Patient
3980
3980
Insufficient Information
276
276
No Code Available
199
199
No Known Impact Or Consequence To Patient
187
187
Not Applicable
107
107
No Patient Involvement
89
89
No Information
49
49
Foreign Body In Patient
40
40
Device Embedded In Tissue or Plaque
8
8
Unspecified Infection
7
7
Pain
6
6
Injury
4
4
Failure of Implant
4
4
Bone Fracture(s)
3
3
Inadequate Osseointegration
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Unspecified Musculoskeletal problem
1
1
Osteopenia/ Osteoporosis
1
1
Patient Problem/Medical Problem
1
1
Hematoma
1
1
Thrombosis
1
1
Non-union Bone Fracture
1
1
Joint Disorder
1
1
Reaction
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
5
Zimmer Biomet, Inc.
II
Feb-14-2018
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