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TPLC
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show TPLC since
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2024
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Device
filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Product Code
NEK
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
3
4
4
6
6
1
4
3
5
2
6
4
3
4
4
0
MDR Year
MDR Reports
MDR Events
2014
1926
1926
2015
1732
1732
2016
1528
1528
2017
799
799
2018
178
178
2019
37
37
2020
31
31
2021
23
23
2022
8
8
2023
14
14
2024
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
6107
6107
Insufficient Information
66
66
Appropriate Term/Code Not Available
20
20
Device Operates Differently Than Expected
18
18
Migration or Expulsion of Device
16
16
Off-Label Use
12
12
Break
11
11
Patient-Device Incompatibility
8
8
Osseointegration Problem
5
5
Malposition of Device
4
4
Microbial Contamination of Device
3
3
Nonstandard Device
3
3
Improper or Incorrect Procedure or Method
3
3
Leak/Splash
2
2
Failure to Osseointegrate
2
2
Aspiration Issue
2
2
Device Dislodged or Dislocated
2
2
Therapeutic or Diagnostic Output Failure
2
2
Patient Device Interaction Problem
1
1
Migration
1
1
Extrusion
1
1
Device Contamination with Chemical or Other Material
1
1
Human-Device Interface Problem
1
1
Structural Problem
1
1
Fitting Problem
1
1
Inaudible or Unclear Audible Prompt/Feedback
1
1
Device Slipped
1
1
Problem with Sterilization
1
1
Use of Device Problem
1
1
Device Emits Odor
1
1
Difficult To Position
1
1
Device Reprocessing Problem
1
1
Collapse
1
1
Entrapment of Device
1
1
Device Expiration Issue
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Injury
3121
3121
Pain
2208
2208
Neuropathy
969
969
Numbness
713
713
Stenosis
627
627
Ambulation Difficulties
596
596
Ossification
588
588
Weakness
508
508
No Code Available
451
451
Tingling
439
439
Neck Pain
395
395
Loss of Range of Motion
300
300
Swelling
283
283
Nerve Damage
270
270
Muscle Spasm(s)
257
257
Headache
211
211
Sleep Dysfunction
204
204
Dysphagia/ Odynophagia
191
191
Burning Sensation
174
174
Inflammation
157
157
High Blood Pressure/ Hypertension
141
141
Depression
140
140
Cyst(s)
116
116
Chest Pain
114
114
Dyspnea
108
108
Nausea
106
106
Edema
102
102
Inadequate Pain Relief
97
97
Osteolysis
92
92
Unspecified Infection
88
88
Fatigue
81
81
Seroma
81
81
Discomfort
79
79
Incontinence
77
77
Dizziness
71
71
Hematoma
65
65
Arthritis
65
65
Respiratory Distress
62
62
Vomiting
61
61
Neck Stiffness
58
58
Cramp(s)
57
57
Post Operative Wound Infection
50
50
Fever
48
48
Urinary Tract Infection
47
47
Anxiety
46
46
Muscle Weakness
43
43
Nerve Proximity Nos (Not Otherwise Specified)
40
40
Disc Impingement
38
38
Hernia
38
38
Pneumonia
38
38
Scarring
35
35
Abdominal Pain
33
33
Chronic Obstructive Pulmonary Disease (COPD)
33
33
Disability
33
33
Dysphasia
32
32
Bone Fracture(s)
32
32
Paralysis
32
32
Thyroid Problems
29
29
Palpitations
29
29
Rash
27
27
Diarrhea
27
27
Wound Dehiscence
27
27
Bronchitis
26
26
Sore Throat
26
26
No Known Impact Or Consequence To Patient
25
25
Anemia
24
24
Neurological Deficit/Dysfunction
23
23
Arachnoiditis, Spinal
23
23
Weight Changes
22
22
Urinary Retention
20
20
Scar Tissue
20
20
Fall
20
20
No Information
19
19
Bacterial Infection
18
18
Failure of Implant
18
18
Arthralgia
18
18
Joint Swelling
17
17
Chills
17
17
Osteopenia/ Osteoporosis
17
17
Sweating
17
17
Respiratory Tract Infection
17
17
Patient Problem/Medical Problem
17
17
Dysuria
17
17
Shaking/Tremors
15
15
Malaise
15
15
Tachycardia
15
15
Asthma
15
15
Sinus Perforation
14
14
Myalgia
14
14
Cancer
14
14
Ulcer
13
13
Urinary Frequency
13
13
Syncope
13
13
Contusion
13
13
Death
13
13
Hearing Loss
13
13
Calcium Deposits/Calcification
12
12
Apnea
12
12
Abscess
12
12
Distress
12
12
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Sofamor Danek USA Inc
II
Nov-09-2018
2
Medtronic Sofamor Danek USA Inc
II
Jun-25-2013
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