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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 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 206 206
2021 474 474
2022 345 345
2023 250 250
2024 62 62

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 575 575
Adverse Event Without Identified Device or Use Problem 443 443
Migration 199 199
Difficult to Open or Close 65 65
Device Dislodged or Dislocated 51 51
Lack of Effect 46 46
Material Twisted/Bent 26 26
Defective Device 11 11
Malposition of Device 11 11
Break 7 7
Mechanical Problem 4 4
Fracture 3 3
Insufficient Information 3 3
Appropriate Term/Code Not Available 3 3
Use of Device Problem 2 2
Expiration Date Error 2 2
Device Fell 2 2
Physical Resistance/Sticking 1 1
Failure to Disconnect 1 1
Retraction Problem 1 1
Material Fragmentation 1 1
Crack 1 1
Detachment of Device or Device Component 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 675 675
Pain 221 221
No Code Available 134 134
Insufficient Information 130 130
Bone Fracture(s) 77 77
Vertebral Fracture 55 55
Inadequate Pain Relief 47 47
Therapeutic Effects, Unexpected 42 42
Discomfort 35 35
Fall 25 25
Unspecified Infection 21 21
No Known Impact Or Consequence To Patient 18 18
Complaint, Ill-Defined 17 17
Numbness 14 14
Implant Pain 11 11
Cerebrospinal Fluid Leakage 8 8
Fluid Discharge 7 7
Paralysis 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Fever 5 5
Swelling/ Edema 5 5
Impaired Healing 5 5
Injury 4 4
Vomiting 4 4
Dyspnea 4 4
Hematoma 3 3
Hemorrhage/Bleeding 3 3
Bacterial Infection 3 3
Hypoxia 3 3
Muscle Weakness 3 3
Stenosis 3 3
Respiratory Insufficiency 3 3
Foreign Body In Patient 3 3
Confusion/ Disorientation 2 2
Blood Loss 2 2
Movement Disorder 2 2
No Consequences Or Impact To Patient 2 2
Spinal Cord Injury 2 2
Urinary Retention 2 2
Cardiac Arrest 2 2
Neurological Deficit/Dysfunction 2 2
Respiratory Distress 2 2
Seroma 2 2
Erosion 2 2
Bradycardia 2 2
Abscess 2 2
Airway Obstruction 2 2
Hypersensitivity/Allergic reaction 2 2
Low Blood Pressure/ Hypotension 1 1
Wound Dehiscence 1 1
Pulmonary Embolism 1 1
Apnea 1 1
Arrhythmia 1 1
Bruise/Contusion 1 1
Burn(s) 1 1
Skin Irritation 1 1
Scar Tissue 1 1
Rash 1 1
Nerve Damage 1 1
Muscle Spasm(s) 1 1
Failure of Implant 1 1
Incontinence 1 1
Urinary Tract Infection 1 1
Burning Sensation 1 1
Tingling 1 1
Arthralgia 1 1
Disability 1 1
Post Operative Wound Infection 1 1
Irregular Pulse 1 1
Claudication 1 1
Loss of consciousness 1 1
Thrombosis/Thrombus 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Skin Inflammation/ Irritation 1 1
Patient Problem/Medical Problem 1 1
No Information 1 1
Balance Problems 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
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