• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device orthosis, spine, plate, laminoplasty, metal
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 1
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
VY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 8 8
2020 2 2
2021 7 7
2022 16 16
2023 5 5
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Expiration Date Error 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Migration 6 6
Device Dislodged or Dislocated 5 5
Difficult to Insert 5 5
Migration or Expulsion of Device 3 3
Product Quality Problem 2 2
Failure to Align 2 2
Mechanical Problem 2 2
Break 1 1
Loose or Intermittent Connection 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
No Known Impact Or Consequence To Patient 7 7
Insufficient Information 4 4
Nerve Damage 4 4
Pain 4 4
Paralysis 3 3
Bone Fracture(s) 3 3
Cerebrospinal Fluid Leakage 2 2
Paresis 2 2
Perforation of Vessels 1 1
No Consequences Or Impact To Patient 1 1
Non-union Bone Fracture 1 1
Impaired Healing 1 1
Numbness 1 1
Post Operative Wound Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Failure of Implant 1 1
Unspecified Tissue Injury 1 1

-
-