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
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
prosthesis, intervertebral disc
Product Code
MJO
Device Class
3
Premarket Approvals (PMA)
2020
2021
2022
2023
2024
2025
21
17
11
12
13
1
MDR Year
MDR Reports
MDR Events
2020
345
345
2021
308
308
2022
263
263
2023
278
278
2024
315
315
2025
29
29
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
311
311
Migration
257
257
Insufficient Information
220
220
Patient-Device Incompatibility
181
181
Patient Device Interaction Problem
132
132
Detachment of Device or Device Component
91
91
Migration or Expulsion of Device
68
68
Expulsion
54
54
Collapse
43
43
Appropriate Term/Code Not Available
41
41
Malposition of Device
37
37
Osseointegration Problem
35
35
Loosening of Implant Not Related to Bone-Ingrowth
33
33
Fracture
31
31
Mechanical Problem
24
24
Inadequacy of Device Shape and/or Size
24
24
Biocompatibility
19
19
Device Dislodged or Dislocated
17
17
Unintended Movement
14
14
Positioning Problem
14
14
Use of Device Problem
14
14
Improper or Incorrect Procedure or Method
13
13
Break
13
13
Off-Label Use
10
10
Loss of Osseointegration
10
10
Material Fragmentation
9
9
Physical Resistance/Sticking
9
9
Failure to Align
7
7
Compatibility Problem
7
7
No Apparent Adverse Event
6
6
Failure to Osseointegrate
5
5
Naturally Worn
5
5
Unstable
4
4
Material Deformation
4
4
Scratched Material
3
3
Difficult to Remove
3
3
Therapeutic or Diagnostic Output Failure
3
3
Material Twisted/Bent
3
3
Mechanics Altered
3
3
Material Separation
3
3
Material Split, Cut or Torn
2
2
Device-Device Incompatibility
2
2
Entrapment of Device
2
2
Expiration Date Error
2
2
Structural Problem
2
2
Material Disintegration
2
2
Noise, Audible
2
2
Human-Device Interface Problem
2
2
Output Problem
2
2
Installation-Related Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
290
290
Insufficient Information
239
239
No Clinical Signs, Symptoms or Conditions
192
192
Neck Pain
188
188
Osteolysis
148
148
Ossification
99
99
Failure of Implant
97
97
No Code Available
70
70
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
62
62
Unspecified Infection
55
55
No Known Impact Or Consequence To Patient
39
39
Numbness
35
35
Dysphagia/ Odynophagia
32
32
Implant Pain
26
26
Inflammation
24
24
Inadequate Pain Relief
23
23
Stenosis
20
20
Hypersensitivity/Allergic reaction
20
20
No Information
19
19
Vertebral Fracture
18
18
Spinal Column Injury
17
17
Muscle Weakness
17
17
Joint Laxity
17
17
Loss of Range of Motion
15
15
Nerve Damage
14
14
Paralysis
14
14
Bone Fracture(s)
14
14
Metal Related Pathology
13
13
Joint Disorder
13
13
Neuropathy
12
12
Patient Problem/Medical Problem
12
12
Fall
11
11
Unspecified Musculoskeletal problem
10
10
Unspecified Blood or Lymphatic problem
9
9
Foreign Body In Patient
9
9
No Consequences Or Impact To Patient
9
9
Neuralgia
8
8
Headache
8
8
Spinal Cord Injury
7
7
Bacterial Infection
7
7
Abscess
7
7
Cramp(s) /Muscle Spasm(s)
7
7
Paresis
7
7
Hemorrhage/Bleeding
7
7
Peritonitis
6
6
Erosion
6
6
Ambulation Difficulties
6
6
Intervertebral Disc Compression or Protrusion
6
6
Peripheral Nervous Injury
6
6
Joint Dislocation
6
6
Recalls
Manufacturer
Recall Class
Date Posted
1
Centinel Spine, Inc.
II
Sep-24-2024
2
Centinel Spine, Inc.
II
Apr-09-2021
3
Medicrea International
II
Aug-24-2023
4
NuVasive Inc
II
Jul-22-2022
-
-