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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeNQW
Regulation Number 888.3050
Device Class 2


Premarket Reviews
ManufacturerDecision
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
2026 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 31 31
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
Entrapment of Device 1 1
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 32 32
Device Embedded In Tissue or Plaque 21 21
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Impaired Healing 1 1
Nicks, cuts or tears of dura or other tissues by device 1 1
Post Operative Wound Infection 1 1
Ossification 1 1
Paralysis 1 1
Foreign Body In Patient 1 1
Numbness 1 1
Unspecified Tissue Injury 1 1
Perforation of Vessels 1 1
Non-union Bone Fracture 1 1
Dysphagia/ Odynophagia 1 1
Vertebral Fracture 1 1
Spinal Cord Injury 1 1

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