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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)
2019 2020 2021 2022 2023 2024
2 10 3 2 2 2

MDR Year MDR Reports MDR Events
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 597 597
Adverse Event Without Identified Device or Use Problem 457 457
Migration 203 203
Difficult to Open or Close 67 67
Device Dislodged or Dislocated 57 57
Lack of Effect 55 55
Material Twisted/Bent 27 27
Malposition of Device 12 12
Defective Device 11 11
Break 7 7
Mechanical Problem 4 4
Insufficient Information 3 3
Fracture 3 3
Appropriate Term/Code Not Available 3 3
Device Fell 2 2
Expiration Date Error 2 2
Use of Device Problem 2 2
Material Fragmentation 1 1
Human-Device Interface Problem 1 1
Physical Resistance/Sticking 1 1
Crack 1 1
Retraction Problem 1 1
Detachment of Device or Device Component 1 1
Failure to Disconnect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 701 701
Pain 242 242
No Code Available 134 134
Insufficient Information 130 130
Bone Fracture(s) 81 81
Vertebral Fracture 55 55
Inadequate Pain Relief 47 47
Therapeutic Effects, Unexpected 42 42
Discomfort 35 35
Fall 27 27
Unspecified Infection 21 21
Numbness 18 18
No Known Impact Or Consequence To Patient 18 18
Complaint, Ill-Defined 17 17
Implant Pain 12 12
Cerebrospinal Fluid Leakage 8 8
Fluid Discharge 7 7
Impaired Healing 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Paralysis 6 6
Fever 5 5
Swelling/ Edema 5 5
Dyspnea 5 5
Injury 4 4
Vomiting 4 4
Muscle Weakness 4 4
Stenosis 3 3
Balance Problems 3 3
Hematoma 3 3
Hypoxia 3 3
Paresthesia 3 3
Urinary Retention 3 3
Bacterial Infection 3 3
Hemorrhage/Bleeding 3 3
Respiratory Insufficiency 3 3
Foreign Body In Patient 3 3
Bradycardia 2 2
Abscess 2 2
No Consequences Or Impact To Patient 2 2
Erosion 2 2
Airway Obstruction 2 2
Spinal Cord Injury 2 2
Seroma 2 2
Confusion/ Disorientation 2 2
Movement Disorder 2 2
Cardiac Arrest 2 2
Neurological Deficit/Dysfunction 2 2
Blood Loss 2 2
Respiratory Distress 2 2
Hypersensitivity/Allergic reaction 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
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