TPLC - Total Product Life Cycle

• Device: orthosis, spine, plate, laminoplasty, metal
• Regulation Description: Spinal interlaminal fixation orthosis.
• Definition: This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.
• Product Code: NQW
• Regulation Number: 888.3050
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
CURITEVA, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC SOFAMOR DANEK
	SUBSTANTIALLY EQUIVALENT	1
VY SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2021	7	7
2022	16	16
2023	5	5
2024	15	15
2025	33	33

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	25	25
Adverse Event Without Identified Device or Use Problem	13	13
Patient-Device Incompatibility	9	9
Expiration Date Error	9	9
Difficult to Insert	5	5
Migration	3	3
Mechanical Problem	2	2
Wrong Label	2	2
Failure to Align	2	2
Product Quality Problem	2	2
Device Dislodged or Dislocated	2	2
Insufficient Information	1	1
Positioning Problem	1	1
Packaging Problem	1	1
Missing Information	1	1
Loose or Intermittent Connection	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	28	28
Device Embedded In Tissue or Plaque	20	20
Failure of Implant	8	8
Nerve Damage	6	6
Pain	6	6
Bone Fracture(s)	4	4
Insufficient Information	4	4
Cerebrospinal Fluid Leakage	3	3
Unspecified Infection	2	2
Paresis	2	2
Impaired Healing	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Nicks, cuts or tears of dura or other tissues by device	1	1
Ossification	1	1
Post Operative Wound Infection	1	1
Paralysis	1	1
Numbness	1	1
Dysphagia/ Odynophagia	1	1
Perforation of Vessels	1	1
Non-union Bone Fracture	1	1
Unspecified Tissue Injury	1	1
Spinal Cord Injury	1	1
Vertebral Fracture	1	1