Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
template
Product Code
HWT
Regulation Number
888.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
741
741
2020
938
938
2021
2177
2177
2022
2096
2096
2023
2601
2601
2024
475
475
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
4228
4228
Naturally Worn
1353
1353
Device-Device Incompatibility
1170
1170
Scratched Material
919
919
Crack
683
683
Detachment of Device or Device Component
568
568
Material Deformation
424
424
Material Twisted/Bent
398
398
Contamination /Decontamination Problem
300
300
Illegible Information
267
267
Fracture
263
263
Material Integrity Problem
188
188
Material Discolored
140
140
Mechanical Jam
134
134
Peeled/Delaminated
127
127
Component Missing
84
84
Adverse Event Without Identified Device or Use Problem
84
84
Unintended Movement
60
60
Entrapment of Device
59
59
No Apparent Adverse Event
58
58
Use of Device Problem
53
53
Corroded
43
43
Incorrect Measurement
41
41
Failure to Cut
40
40
Physical Resistance/Sticking
36
36
Appropriate Term/Code Not Available
23
23
Structural Problem
22
22
Dull, Blunt
18
18
Mechanical Problem
16
16
Loose or Intermittent Connection
15
15
Device Dislodged or Dislocated
15
15
Insufficient Information
13
13
Improper or Incorrect Procedure or Method
10
10
Compatibility Problem
9
9
Connection Problem
8
8
Difficult to Open or Close
8
8
Off-Label Use
8
8
Difficult to Remove
8
8
Material Fragmentation
7
7
Loss of Osseointegration
7
7
Inadequacy of Device Shape and/or Size
6
6
Difficult or Delayed Separation
6
6
Migration
5
5
Device Slipped
5
5
Loss of or Failure to Bond
5
5
Difficult to Insert
4
4
Fitting Problem
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Positioning Problem
4
4
Separation Problem
4
4
Material Split, Cut or Torn
3
3
Defective Device
3
3
Difficult to Advance
3
3
Device Damaged Prior to Use
3
3
Degraded
3
3
Tear, Rip or Hole in Device Packaging
2
2
Pitted
2
2
Device Markings/Labelling Problem
2
2
Device Contaminated During Manufacture or Shipping
2
2
Malposition of Device
2
2
Patient-Device Incompatibility
2
2
Deformation Due to Compressive Stress
2
2
Device Handling Problem
2
2
Patient Device Interaction Problem
2
2
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Device Difficult to Maintain
1
1
Difficult to Open or Remove Packaging Material
1
1
Packaging Problem
1
1
Mechanics Altered
1
1
Lack of Maintenance Documentation or Guidelines
1
1
Device Damaged by Another Device
1
1
Failure to Align
1
1
Expiration Date Error
1
1
Failure to Disconnect
1
1
Separation Failure
1
1
Flaked
1
1
Material Disintegration
1
1
Display Difficult to Read
1
1
Labelling, Instructions for Use or Training Problem
1
1
Delivered as Unsterile Product
1
1
Inaccurate Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
7086
7086
No Consequences Or Impact To Patient
1264
1264
Insufficient Information
350
350
No Code Available
125
125
No Patient Involvement
95
95
Not Applicable
65
65
No Known Impact Or Consequence To Patient
64
64
No Information
29
29
Foreign Body In Patient
25
25
Pain
23
23
Bone Fracture(s)
14
14
Unspecified Infection
11
11
Limb Fracture
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Injury
6
6
Joint Dislocation
5
5
Joint Laxity
4
4
Loss of Range of Motion
4
4
Cyst(s)
3
3
Metal Related Pathology
3
3
Unspecified Tissue Injury
3
3
Physical Asymmetry
3
3
Bruise/Contusion
2
2
Device Embedded In Tissue or Plaque
2
2
Osteolysis
2
2
Failure of Implant
2
2
Laceration(s)
2
2
Nerve Damage
1
1
Infiltration into Tissue
1
1
Inflammation
1
1
Synovitis
1
1
Discomfort
1
1
Pulmonary Embolism
1
1
Adhesion(s)
1
1
Death
1
1
Fall
1
1
Foreign Body Reaction
1
1
Ambulation Difficulties
1
1
Depression
1
1
Non-union Bone Fracture
1
1
Patient Problem/Medical Problem
1
1
Inadequate Osseointegration
1
1
Unspecified Musculoskeletal problem
1
1
Swelling/ Edema
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DePuy Orthopaedics, Inc.
II
Jul-20-2022
2
Materialise USA LLC
II
Aug-24-2022
-
-