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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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

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

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