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TPLC
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show TPLC since
2009
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2014
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2024
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Device
prosthesis, intervertebral disc
Product Code
MJO
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
1
6
11
6
12
25
11
14
15
9
12
21
17
11
12
3
MDR Year
MDR Reports
MDR Events
2014
328
328
2015
724
724
2016
161
161
2017
277
277
2018
369
369
2019
380
380
2020
345
345
2021
308
308
2022
265
265
2023
278
278
2024
46
46
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1145
1145
Migration or Expulsion of Device
447
447
Insufficient Information
290
290
Migration
246
246
Patient-Device Incompatibility
223
223
Detachment of Device or Device Component
153
153
Patient Device Interaction Problem
142
142
Appropriate Term/Code Not Available
126
126
Device Dislodged or Dislocated
107
107
Break
107
107
Malposition of Device
92
92
Positioning Problem
72
72
Unintended Movement
61
61
Collapse
58
58
Material Separation
55
55
Expulsion
55
55
Disassembly
54
54
Mechanical Problem
50
50
Improper or Incorrect Procedure or Method
41
41
Fracture
39
39
Inadequacy of Device Shape and/or Size
36
36
Disconnection
35
35
Device Operates Differently Than Expected
34
34
Device Handling Problem
31
31
Loosening of Implant Not Related to Bone-Ingrowth
31
31
Device Slipped
30
30
Loose or Intermittent Connection
28
28
Misassembled
27
27
Osseointegration Problem
25
25
Mechanical Jam
22
22
Use of Device Problem
22
22
Biocompatibility
20
20
Detachment Of Device Component
20
20
Physical Resistance/Sticking
17
17
Material Fragmentation
15
15
Fitting Problem
15
15
No Apparent Adverse Event
13
13
Material Deformation
12
12
Device-Device Incompatibility
12
12
Positioning Failure
12
12
Difficult to Insert
11
11
Failure to Align
11
11
Material Twisted/Bent
11
11
Failure to Osseointegrate
10
10
Unstable
9
9
Device Inoperable
9
9
Off-Label Use
9
9
Difficult to Remove
9
9
Compatibility Problem
9
9
Difficult To Position
8
8
Failure To Adhere Or Bond
8
8
Component Falling
7
7
Loss of Osseointegration
7
7
Component Missing
6
6
Sticking
6
6
Metal Shedding Debris
6
6
Failure to Cut
6
6
Material Disintegration
6
6
Mechanics Altered
5
5
Naturally Worn
5
5
Noise, Audible
5
5
Material Integrity Problem
4
4
Material Split, Cut or Torn
4
4
Entrapment of Device
4
4
Device Operational Issue
4
4
Incomplete or Missing Packaging
3
3
Unintended System Motion
3
3
Misassembled During Installation
3
3
Device Fell
3
3
Output Problem
3
3
Packaging Problem
3
3
Installation-Related Problem
3
3
Therapeutic or Diagnostic Output Failure
3
3
Misassembly by Users
2
2
Material Protrusion/Extrusion
2
2
Separation Problem
2
2
Peeled/Delaminated
2
2
Sensing Intermittently
2
2
Failure to Sense
2
2
Structural Problem
2
2
Defective Component
2
2
Defective Device
2
2
Physical Resistance
2
2
Failure to Advance
2
2
Failure to Disconnect
2
2
Separation Failure
1
1
Device Packaging Compromised
1
1
Device Sensing Problem
1
1
Blocked Connection
1
1
Deformation Due to Compressive Stress
1
1
Connection Problem
1
1
Activation, Positioning or Separation Problem
1
1
Microbial Contamination of Device
1
1
Material Perforation
1
1
Device Issue
1
1
Unraveled Material
1
1
Shelf Life Exceeded
1
1
Material Rupture
1
1
Product Quality Problem
1
1
No Device Output
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
862
862
No Code Available
680
680
No Known Impact Or Consequence To Patient
454
455
Failure of Implant
377
378
Neck Pain
325
325
No Consequences Or Impact To Patient
219
219
Ossification
216
216
Insufficient Information
180
180
No Clinical Signs, Symptoms or Conditions
130
130
Impaired Healing
126
126
Osteolysis
121
121
No Information
117
117
Loss of Range of Motion
83
83
Numbness
79
79
Unspecified Infection
68
68
Bone Fracture(s)
63
63
Dysphagia/ Odynophagia
59
59
Stenosis
54
54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
54
54
Nerve Damage
51
51
Neuropathy
47
47
Inflammation
37
37
Patient Problem/Medical Problem
33
33
Discomfort
32
32
Reaction
32
32
Weakness
31
31
Neurological Deficit/Dysfunction
30
30
Injury
28
28
Muscle Weakness
26
26
Tingling
25
25
Hypersensitivity/Allergic reaction
24
24
Headache
24
24
Fall
23
23
Arthritis
22
22
Spinal Column Injury
22
22
Hematoma
21
21
Inadequate Pain Relief
21
21
Paralysis
17
17
Joint Disorder
16
16
Post Operative Wound Infection
16
16
Joint Laxity
16
16
Vertebral Fracture
15
15
Limited Mobility Of The Implanted Joint
15
15
Device Embedded In Tissue or Plaque
15
15
Neck Stiffness
15
15
Abscess
14
14
Foreign Body In Patient
14
14
Metal Related Pathology
12
12
Implant Pain
12
12
Rash
11
11
Muscle Spasm(s)
11
11
Non-union Bone Fracture
11
11
Complaint, Ill-Defined
11
11
Bacterial Infection
10
10
Cyst(s)
10
10
Laceration(s)
9
9
Hemorrhage/Bleeding
9
9
Swelling
9
9
Hernia
9
9
Tissue Damage
9
9
Disability
9
9
Spinal Cord Injury
9
9
No Patient Involvement
9
9
Unspecified Blood or Lymphatic problem
9
9
Inadequate Osseointegration
8
8
Ambulation Difficulties
8
8
Joint Dislocation
8
8
Dysphasia
8
8
Nausea
8
8
Paresis
8
8
Undesired Nerve Stimulation
8
8
Fatigue
8
8
Cerebrospinal Fluid Leakage
7
7
Irritation
7
7
Scar Tissue
7
7
Quadriplegia
7
7
Cramp(s) /Muscle Spasm(s)
7
7
Decreased Sensitivity
7
7
Constipation
6
6
Intervertebral Disc Compression or Protrusion
6
6
Neuralgia
6
6
Peripheral Nervous Injury
6
6
Osteopenia/ Osteoporosis
6
6
Disc Impingement
6
6
Sedation
6
6
Dyskinesia
6
6
Peritonitis
6
6
Hypoesthesia
6
6
Death
6
6
Wound Dehiscence
6
6
Abdominal Pain
5
5
Erosion
5
5
Erythema
5
5
Apnea
5
5
Dizziness
5
5
Thrombosis
5
5
Paresthesia
5
5
Paraplegia
5
5
Unspecified Musculoskeletal problem
5
5
Unspecified Tissue Injury
5
5
Recalls
Manufacturer
Recall Class
Date Posted
1
Centinel Spine, Inc.
II
Apr-09-2021
2
Medicrea International
II
Aug-24-2023
3
Medtronic Sofamor Danek USA Inc
II
May-04-2018
4
NuVasive Inc
II
Jul-22-2022
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