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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)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
4
3
1
2
2
2
5
4
5
9
2
10
3
2
2
1
MDR Year
MDR Reports
MDR Events
2014
42
42
2015
33
33
2016
31
31
2017
34
34
2018
17
17
2019
2
2
2020
206
206
2021
474
474
2022
345
345
2023
250
250
2024
33
33
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Integrity Problem
565
565
Adverse Event Without Identified Device or Use Problem
519
519
Migration
195
195
Difficult to Open or Close
65
65
Device Dislodged or Dislocated
51
51
Lack of Effect
42
42
Material Twisted/Bent
26
26
Migration or Expulsion of Device
24
24
Insufficient Information
22
22
Malposition of Device
13
13
Break
12
12
Defective Device
11
11
Fracture
8
8
Improper or Incorrect Procedure or Method
6
6
Use of Device Problem
4
4
Mechanical Problem
4
4
Appropriate Term/Code Not Available
4
4
Difficult or Delayed Positioning
3
3
Material Fragmentation
3
3
Unstable
2
2
Expiration Date Error
2
2
Patient-Device Incompatibility
2
2
Activation, Positioning or Separation Problem
2
2
Device Fell
2
2
Device Handling Problem
1
1
Physical Resistance/Sticking
1
1
Human-Device Interface Problem
1
1
No Pressure
1
1
Osseointegration Problem
1
1
Unintended Movement
1
1
No Apparent Adverse Event
1
1
Detachment of Device or Device Component
1
1
Failure to Disconnect
1
1
Crack
1
1
Nonstandard Device
1
1
Retraction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
659
659
Pain
264
265
No Code Available
156
156
Insufficient Information
128
128
Bone Fracture(s)
102
102
Inadequate Pain Relief
58
58
Vertebral Fracture
53
53
Therapeutic Effects, Unexpected
42
42
Discomfort
37
37
No Known Impact Or Consequence To Patient
32
32
Unspecified Infection
30
30
Fall
24
24
Numbness
19
20
Stenosis
19
19
Complaint, Ill-Defined
17
17
Cerebrospinal Fluid Leakage
12
12
Implant Pain
11
11
Claudication
8
8
No Information
8
8
Neurological Deficit/Dysfunction
7
7
Fluid Discharge
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Hemorrhage/Bleeding
6
7
Injury
6
6
Paralysis
6
6
Fever
5
5
Swelling/ Edema
5
5
Impaired Healing
5
5
Failure of Implant
5
5
Urinary Retention
4
4
Foreign Body In Patient
4
4
Dyspnea
4
4
Hematoma
4
4
Vomiting
4
4
Ambulation Difficulties
3
3
Abscess
3
3
Bacterial Infection
3
3
Hypoxia
3
3
Patient Problem/Medical Problem
3
3
Respiratory Insufficiency
3
3
Muscle Weakness
3
3
Incontinence
3
3
Dysphasia
2
2
Respiratory Distress
2
2
Post Operative Wound Infection
2
2
Perforation of Vessels
2
2
No Consequences Or Impact To Patient
2
2
Bradycardia
2
2
Movement Disorder
2
2
Confusion/ Disorientation
2
2
Spinal Cord Injury
2
2
Cyst(s)
2
2
Seroma
2
2
Tingling
2
2
Therapeutic Response, Decreased
2
3
Hypersensitivity/Allergic reaction
2
2
Erosion
2
2
Prolapse
2
2
Device Embedded In Tissue or Plaque
2
2
Cardiac Arrest
2
2
Blood Loss
2
2
Balance Problems
1
1
Nerve Damage
1
1
Skin Irritation
1
1
Irregular Pulse
1
1
Rash
1
1
Wound Dehiscence
1
1
Low Blood Pressure/ Hypotension
1
1
Dysuria
1
2
Osteolysis
1
1
Loss of consciousness
1
1
Disability
1
1
Urinary Tract Infection
1
1
Bruise/Contusion
1
1
Skin Inflammation/ Irritation
1
1
Apnea
1
1
Loss of Range of Motion
1
1
Inflammation
1
2
Burn(s)
1
1
Muscle Spasm(s)
1
1
Impotence
1
1
Thrombosis/Thrombus
1
1
Pulmonary Embolism
1
1
Swelling
1
1
Constipation
1
2
Arthralgia
1
1
Tissue Damage
1
1
Nausea
1
1
Arrhythmia
1
1
Spinal Column Injury
1
1
Ulcer
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Sleep Dysfunction
1
1
Emotional Changes
1
2
Airway Obstruction
1
1
Burning Sensation
1
1
Scar Tissue
1
1
Weakness
1
1
Inadequate Osseointegration
1
1
Ossification
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
3
Theragenics Corporation
II
Mar-31-2009
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