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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeNQO
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 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 567 567
Adverse Event Without Identified Device or Use Problem 519 519
Migration 198 198
Difficult to Open or Close 66 66
Device Dislodged or Dislocated 52 52
Lack of Effect 43 43
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 663 663
Pain 268 269
No Code Available 156 156
Insufficient Information 129 129
Bone Fracture(s) 102 102
Inadequate Pain Relief 58 58
Vertebral Fracture 53 53
Therapeutic Effects, Unexpected 42 42
Discomfort 38 38
No Known Impact Or Consequence To Patient 32 32
Unspecified Infection 30 30
Fall 24 24
Stenosis 19 19
Numbness 19 20
Complaint, Ill-Defined 17 17
Cerebrospinal Fluid Leakage 12 12
Implant Pain 11 11
No Information 8 8
Claudication 8 8
Neurological Deficit/Dysfunction 7 7
Fluid Discharge 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Injury 6 6
Paralysis 6 6
Hemorrhage/Bleeding 6 7
Failure of Implant 5 5
Fever 5 5
Impaired Healing 5 5
Swelling/ Edema 5 5
Foreign Body In Patient 4 4
Urinary Retention 4 4
Vomiting 4 4
Dyspnea 4 4
Hematoma 4 4
Hypoxia 3 3
Muscle Weakness 3 3
Abscess 3 3
Bacterial Infection 3 3
Incontinence 3 3
Patient Problem/Medical Problem 3 3
Ambulation Difficulties 3 3
Respiratory Insufficiency 3 3
Device Embedded In Tissue or Plaque 2 2
Prolapse 2 2
Movement Disorder 2 2
Respiratory Distress 2 2
Seroma 2 2
Tingling 2 2
Dysphasia 2 2
No Consequences Or Impact To Patient 2 2
Perforation of Vessels 2 2
Therapeutic Response, Decreased 2 3
Confusion/ Disorientation 2 2
Blood Loss 2 2
Spinal Cord Injury 2 2
Post Operative Wound Infection 2 2
Erosion 2 2
Bradycardia 2 2
Cyst(s) 2 2
Cardiac Arrest 2 2
Hypersensitivity/Allergic reaction 2 2
Low Blood Pressure/ Hypotension 1 1
Impotence 1 1
Nausea 1 1
Nerve Damage 1 1
Inflammation 1 2
Muscle Spasm(s) 1 1
Loss of Range of Motion 1 1
Rash 1 1
Wound Dehiscence 1 1
Ossification 1 1
Pulmonary Embolism 1 1
Emotional Changes 1 2
Bruise/Contusion 1 1
Burn(s) 1 1
Airway Obstruction 1 1
Apnea 1 1
Arrhythmia 1 1
Irregular Pulse 1 1
Loss of consciousness 1 1
Inadequate Osseointegration 1 1
Dysuria 1 2
Ulcer 1 1
Arthralgia 1 1
Disability 1 1
Osteolysis 1 1
Weakness 1 1
Burning Sensation 1 1
Urinary Tract Infection 1 1
Tissue Damage 1 1
Skin Irritation 1 1
Spinal Column Injury 1 1
Swelling 1 1
Scar Tissue 1 1
Thrombosis/Thrombus 1 1
Constipation 1 2
Balance Problems 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Skin Inflammation/ Irritation 1 1
Sleep Dysfunction 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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