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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)
2020 2021 2022 2023 2024 2025
10 3 2 2 3 0

MDR Year MDR Reports MDR Events
2020 206 206
2021 474 474
2022 345 345
2023 250 250
2024 159 159
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 621 621
Adverse Event Without Identified Device or Use Problem 471 471
Migration 212 212
Difficult to Open or Close 71 71
Lack of Effect 67 67
Device Dislodged or Dislocated 61 61
Material Twisted/Bent 28 28
Malposition of Device 13 13
Defective Device 11 11
Break 6 6
Mechanical Problem 5 5
Fracture 3 3
Insufficient Information 3 3
Appropriate Term/Code Not Available 3 3
Device Fell 2 2
Use of Device Problem 2 2
Expiration Date Error 2 2
Failure to Disconnect 1 1
Physical Resistance/Sticking 1 1
Retraction Problem 1 1
Human-Device Interface Problem 1 1
Detachment of Device or Device Component 1 1
Material Fragmentation 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 735 735
Pain 258 258
No Code Available 134 134
Insufficient Information 131 131
Bone Fracture(s) 81 81
Vertebral Fracture 55 55
Inadequate Pain Relief 47 47
Therapeutic Effects, Unexpected 42 42
Discomfort 35 35
Fall 28 28
Unspecified Infection 20 20
Numbness 19 19
No Known Impact Or Consequence To Patient 18 18
Complaint, Ill-Defined 17 17
Implant Pain 13 13
Cerebrospinal Fluid Leakage 8 8
Fluid Discharge 7 7
Paralysis 6 6
Muscle Weakness 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Impaired Healing 6 6
Dyspnea 5 5
Fever 5 5
Swelling/ Edema 5 5
Vomiting 4 4
Injury 4 4
Paresthesia 3 3
Balance Problems 3 3
Respiratory Insufficiency 3 3
Stenosis 3 3
Foreign Body In Patient 3 3
Hypoxia 3 3
Hemorrhage/Bleeding 3 3
Hematoma 3 3
Bradycardia 3 3
Bacterial Infection 3 3
Urinary Retention 3 3
Spinal Cord Injury 2 2
Confusion/ Disorientation 2 2
Neurological Deficit/Dysfunction 2 2
Respiratory Distress 2 2
Seroma 2 2
No Consequences Or Impact To Patient 2 2
Movement Disorder 2 2
Blood Loss 2 2
Hypersensitivity/Allergic reaction 2 2
Cardiac Arrest 2 2
Erosion 2 2
Airway Obstruction 2 2
Abscess 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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