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 Code	NQO
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
3	2	2	3	1	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	1258	1258
Adverse Event Without Identified Device or Use Problem	408	408
Difficult to Open or Close	168	168
Migration	167	167
Lack of Effect	84	84
Device Dislodged or Dislocated	61	61
Material Twisted/Bent	45	45
Physical Resistance/Sticking	16	16
Defective Device	12	12
Break	7	7
Malposition of Device	7	7
Nonstandard Device	5	5
Use of Device Problem	4	4
Mechanical Problem	3	3
Expiration Date Error	3	3
Fracture	3	3
Insufficient Information	2	2
Device Fell	2	2
Appropriate Term/Code Not Available	2	2
Material Fragmentation	1	1
Human-Device Interface Problem	1	1
Failure to Disconnect	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1430	1430
Pain	230	230
Insufficient Information	135	135
Vertebral Fracture	64	64
Inadequate Pain Relief	46	46
Foreign Body In Patient	43	43
Bone Fracture(s)	40	40
Discomfort	28	28
Fall	24	24
Numbness	13	13
Implant Pain	13	13
Unspecified Infection	12	12
No Code Available	11	11
Muscle Weakness	7	7
Cerebrospinal Fluid Leakage	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Swelling/ Edema	5	5
Impaired Healing	5	5
Therapeutic Effects, Unexpected	5	5
Paralysis	4	4
Dyspnea	4	4
Fluid Discharge	4	4
Respiratory Insufficiency	3	3
Balance Problems	3	3
Movement Disorder	3	3
Paresthesia	3	3
Fever	3	3
Hematoma	3	3
Hemorrhage/Bleeding	3	3
Bacterial Infection	3	3
Bradycardia	3	3
Hypoxia	3	3
Vomiting	3	3
Urinary Retention	2	2
Erosion	2	2
Abscess	2	2
Airway Obstruction	2	2
Confusion/ Disorientation	2	2
Complaint, Ill-Defined	2	2
Spinal Cord Injury	2	2
Post Operative Wound Infection	1	1
Irregular Pulse	1	1
Arthralgia	1	1
Thrombosis/Thrombus	1	1
Nervous System Injury	1	1
No Known Impact Or Consequence To Patient	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Skin Inflammation/ Irritation	1	1
Arrhythmia	1	1
Wound Dehiscence	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Neuromodulation Corporation	II	Sep-02-2025
2	Boston Scientific Neuromodulation Corporation	II	Jun-15-2023
3	Boston Scientific Neuromodulation Corporation	II	Nov-14-2022