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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 2

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 113 113

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 599 599
Adverse Event Without Identified Device or Use Problem 540 540
Migration 203 203
Difficult to Open or Close 68 68
Device Dislodged or Dislocated 61 61
Lack of Effect 55 55
Material Twisted/Bent 27 27
Migration or Expulsion of Device 24 24
Insufficient Information 22 22
Malposition of Device 14 14
Break 12 12
Defective Device 11 11
Fracture 8 8
Improper or Incorrect Procedure or Method 6 6
Mechanical Problem 4 4
Use of Device Problem 4 4
Appropriate Term/Code Not Available 4 4
Material Fragmentation 3 3
Difficult or Delayed Positioning 3 3
Unstable 2 2
Activation, Positioning or Separation Problem 2 2
Patient-Device Incompatibility 2 2
Device Fell 2 2
Expiration Date Error 2 2
Unintended Movement 1 1
Nonstandard Device 1 1
Human-Device Interface Problem 1 1
No Pressure 1 1
Device Handling Problem 1 1
Physical Resistance/Sticking 1 1
Crack 1 1
Detachment of Device or Device Component 1 1
No Apparent Adverse Event 1 1
Retraction Problem 1 1
Failure to Disconnect 1 1
Osseointegration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 701 701
Pain 296 297
No Code Available 156 156
Insufficient Information 130 130
Bone Fracture(s) 106 106
Inadequate Pain Relief 58 58
Vertebral Fracture 55 55
Therapeutic Effects, Unexpected 42 42
Discomfort 38 38
No Known Impact Or Consequence To Patient 32 32
Unspecified Infection 30 30
Fall 27 27
Numbness 23 24
Stenosis 19 19
Complaint, Ill-Defined 17 17
Cerebrospinal Fluid Leakage 13 13
Implant Pain 12 12
Claudication 8 8
No Information 8 8
Fluid Discharge 7 7
Neurological Deficit/Dysfunction 7 7
Impaired Healing 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Paralysis 6 6
Injury 6 6
Hemorrhage/Bleeding 6 7
Swelling/ Edema 5 5
Failure of Implant 5 5
Dyspnea 5 5
Urinary Retention 5 5
Fever 5 5
Hematoma 4 4
Muscle Weakness 4 4
Vomiting 4 4
Foreign Body In Patient 4 4
Respiratory Insufficiency 3 3
Bacterial Infection 3 3
Abscess 3 3
Incontinence 3 3
Patient Problem/Medical Problem 3 3
Balance Problems 3 3
Paresthesia 3 3
Ambulation Difficulties 3 3
Hypoxia 3 3
Perforation of Vessels 2 2
Tingling 2 2
Hypersensitivity/Allergic reaction 2 2
Prolapse 2 2
Therapeutic Response, Decreased 2 3
Seroma 2 2

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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