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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
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
AESCULAP IMPLANT SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP IMPLANT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET SPINE (AKA EBI, LLC)
  SUBSTANTIALLY EQUIVALENT 1
CHOICE SPINE, LP
  SUBSTANTIALLY EQUIVALENT 1
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
NEUROVENTION LLC
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC. (DBA RTI SURGICAL, INC.)
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRUM SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 1
VY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 5 5
2015 11 11
2016 7 7
2017 19 19
2018 5 5
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
Adverse Event Without Identified Device or Use Problem 20 20
Migration or Expulsion of Device 13 13
Device Markings/Labelling Problem 12 12
Expiration Date Error 9 9
Break 8 8
Migration 6 6
Device Dislodged or Dislocated 6 6
Difficult to Insert 5 5
Product Quality Problem 2 2
Mechanical Problem 2 2
Failure to Align 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
No Apparent Adverse Event 1 1
Structural Problem 1 1
Loose or Intermittent Connection 1 1
Disassembly 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 23 23
No Clinical Signs, Symptoms or Conditions 17 17
No Patient Involvement 12 12
No Code Available 7 7
Paralysis 6 6
Pain 5 5
Nerve Damage 4 4
Cerebrospinal Fluid Leakage 4 4
Bone Fracture(s) 4 4
Insufficient Information 4 4
Impaired Healing 3 3
No Consequences Or Impact To Patient 2 2
Injury 2 2
Paresis 2 2
Unspecified Infection 2 2
Post Operative Wound Infection 2 2
Quadriplegia 1 1
Unspecified Tissue Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Muscle Weakness 1 1
Failure of Implant 1 1
Fall 1 1
Scar Tissue 1 1
Perforation of Vessels 1 1
Non-union Bone Fracture 1 1
Numbness 1 1
Neck Pain 1 1

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