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TPLC
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show TPLC since
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2024
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Device
prosthesis, intervertebral disc
Product Code
MJO
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
12
21
17
11
12
10
MDR Year
MDR Reports
MDR Events
2019
380
380
2020
345
345
2021
308
308
2022
265
265
2023
278
278
2024
245
245
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
343
343
Insufficient Information
285
285
Migration
274
274
Patient-Device Incompatibility
210
210
Patient Device Interaction Problem
144
144
Detachment of Device or Device Component
123
123
Migration or Expulsion of Device
72
72
Collapse
57
57
Appropriate Term/Code Not Available
56
56
Expulsion
55
55
Malposition of Device
53
53
Fracture
39
39
Positioning Problem
36
36
Loosening of Implant Not Related to Bone-Ingrowth
35
35
Osseointegration Problem
33
33
Device Dislodged or Dislocated
32
32
Break
29
29
Disconnection
26
26
Inadequacy of Device Shape and/or Size
25
25
Mechanical Problem
24
24
Device Handling Problem
24
24
Biocompatibility
20
20
Misassembled
19
19
Improper or Incorrect Procedure or Method
17
17
Unintended Movement
17
17
Use of Device Problem
14
14
Physical Resistance/Sticking
13
13
No Apparent Adverse Event
12
12
Device-Device Incompatibility
12
12
Off-Label Use
10
10
Material Fragmentation
10
10
Mechanical Jam
9
9
Loss of Osseointegration
9
9
Material Separation
8
8
Compatibility Problem
8
8
Material Twisted/Bent
8
8
Failure to Osseointegrate
7
7
Positioning Failure
7
7
Failure to Align
7
7
Loose or Intermittent Connection
6
6
Unstable
6
6
Naturally Worn
5
5
Component Missing
5
5
Device Slipped
4
4
Material Deformation
4
4
Mechanics Altered
3
3
Noise, Audible
3
3
Difficult to Remove
3
3
Therapeutic or Diagnostic Output Failure
3
3
Material Disintegration
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
346
346
Neck Pain
230
230
Insufficient Information
220
220
No Clinical Signs, Symptoms or Conditions
164
164
Osteolysis
150
150
No Code Available
136
136
No Known Impact Or Consequence To Patient
122
122
Ossification
113
113
Failure of Implant
97
97
No Consequences Or Impact To Patient
91
91
No Information
62
62
Unspecified Infection
61
61
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
59
59
Numbness
45
45
Dysphagia/ Odynophagia
36
36
Patient Problem/Medical Problem
29
29
Inflammation
24
24
Loss of Range of Motion
23
23
Inadequate Pain Relief
23
23
Implant Pain
20
20
Stenosis
20
20
Hypersensitivity/Allergic reaction
19
19
Vertebral Fracture
17
17
Joint Laxity
17
17
Paralysis
17
17
Spinal Column Injury
17
17
Muscle Weakness
16
16
Nerve Damage
15
15
Bone Fracture(s)
15
15
Joint Disorder
13
13
Metal Related Pathology
12
12
Neuropathy
12
12
Fall
11
11
Foreign Body In Patient
10
10
Headache
9
9
Bacterial Infection
9
9
Unspecified Musculoskeletal problem
9
9
Unspecified Blood or Lymphatic problem
9
9
Discomfort
8
8
Ambulation Difficulties
8
8
Spinal Cord Injury
8
8
Neuralgia
8
8
Hemorrhage/Bleeding
7
7
Dysphasia
7
7
Rash
7
7
Paresis
7
7
Cramp(s) /Muscle Spasm(s)
7
7
Abscess
7
7
Peritonitis
6
6
Peripheral Nervous Injury
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
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