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TPLC
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Device
prosthesis, spinous process spacer/plate
Definition
This device is an interspinous spacer or spinous process plate that is implanted between the spinous processes or attached to the spinous process.
Product Code
NQO
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
2
10
3
2
2
1
MDR Year
MDR Reports
MDR Events
2019
2
2
2020
206
206
2021
474
474
2022
345
345
2023
250
250
2024
39
39
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Integrity Problem
565
565
Adverse Event Without Identified Device or Use Problem
436
436
Migration
198
198
Difficult to Open or Close
65
65
Device Dislodged or Dislocated
48
48
Lack of Effect
43
43
Material Twisted/Bent
26
26
Defective Device
11
11
Malposition of Device
11
11
Break
7
7
Mechanical Problem
4
4
Fracture
3
3
Insufficient Information
3
3
Appropriate Term/Code Not Available
3
3
Use of Device Problem
2
2
Expiration Date Error
2
2
Device Fell
2
2
Physical Resistance/Sticking
1
1
Failure to Disconnect
1
1
Retraction Problem
1
1
Material Fragmentation
1
1
Crack
1
1
Detachment of Device or Device Component
1
1
Human-Device Interface Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
663
663
Pain
214
214
No Code Available
134
134
Insufficient Information
129
129
Bone Fracture(s)
77
77
Vertebral Fracture
53
53
Inadequate Pain Relief
47
47
Therapeutic Effects, Unexpected
42
42
Discomfort
35
35
Fall
24
24
Unspecified Infection
21
21
No Known Impact Or Consequence To Patient
18
18
Complaint, Ill-Defined
17
17
Numbness
14
14
Implant Pain
11
11
Fluid Discharge
7
7
Cerebrospinal Fluid Leakage
7
7
Paralysis
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Fever
5
5
Swelling/ Edema
5
5
Impaired Healing
5
5
Injury
4
4
Vomiting
4
4
Dyspnea
4
4
Hematoma
3
3
Hemorrhage/Bleeding
3
3
Bacterial Infection
3
3
Hypoxia
3
3
Muscle Weakness
3
3
Stenosis
3
3
Respiratory Insufficiency
3
3
Foreign Body In Patient
3
3
Confusion/ Disorientation
2
2
Blood Loss
2
2
Movement Disorder
2
2
No Consequences Or Impact To Patient
2
2
Spinal Cord Injury
2
2
Urinary Retention
2
2
Cardiac Arrest
2
2
Neurological Deficit/Dysfunction
2
2
Respiratory Distress
2
2
Seroma
2
2
Erosion
2
2
Bradycardia
2
2
Abscess
2
2
Hypersensitivity/Allergic reaction
2
2
Low Blood Pressure/ Hypotension
1
1
Wound Dehiscence
1
1
Pulmonary Embolism
1
1
Airway Obstruction
1
1
Apnea
1
1
Arrhythmia
1
1
Bruise/Contusion
1
1
Burn(s)
1
1
Skin Irritation
1
1
Scar Tissue
1
1
Rash
1
1
Nerve Damage
1
1
Muscle Spasm(s)
1
1
Failure of Implant
1
1
Incontinence
1
1
Urinary Tract Infection
1
1
Burning Sensation
1
1
Tingling
1
1
Arthralgia
1
1
Disability
1
1
Post Operative Wound Infection
1
1
Irregular Pulse
1
1
Claudication
1
1
Loss of consciousness
1
1
Thrombosis/Thrombus
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Skin Inflammation/ Irritation
1
1
Patient Problem/Medical Problem
1
1
No Information
1
1
Balance Problems
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Neuromodulation Corporation
II
Jun-15-2023
2
Boston Scientific Neuromodulation Corporation
II
Nov-14-2022
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