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TPLC - Total Product Life Cycle
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Device intervertebral fusion device with bone graft, cervical
Definition Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Product CodeODP
Regulation Number 888.3080
Device Class 2


Premarket Reviews
ManufacturerDecision
4WEB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACRO COMPOSITES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ACUITY SURGICAL DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE DEVICE, INC. (ADI) D/B/A RESTOR3D
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE IMPLANTS, INC
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE IMPLANTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ADDIVATION MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTFX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ATLAS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
AURORA SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BACK 2 BASICS DIRECT, LLC
  SUBSTANTIALLY EQUIVALENT 1
BESPOKE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
BLUSTONE SYNERGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHOICESPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
CHOICESPINE, LP
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
CTL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SPINE
  SUBSTANTIALLY EQUIVALENT 1
EMINENT SPINE
  SUBSTANTIALLY EQUIVALENT 1
FLOSPINE
  SUBSTANTIALLY EQUIVALENT 1
G SURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
GBS COMMONWEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
GS MEDICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAPPE SPINE
  SUBSTANTIALLY EQUIVALENT 1
HT MEDICAL D.B.A. XENIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 1
IMPLANET, S.A.
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 3
INTEGRITY SPINE
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
JMT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
K&J CONSULTING CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KAHTNU SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
KEOS
  SUBSTANTIALLY EQUIVALENT 1
LEGEND SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
LNTELIVATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
LUCERO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDITECH SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDYNUS INC.
  SUBSTANTIALLY EQUIVALENT 1
MET ONE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 2
NANOVIS LLC
  SUBSTANTIALLY EQUIVALENT 2
NEUROSTRUCTURES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NGMEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 3
NUVASIVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 5
PAONAN BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PARADIGM SPINE
  SUBSTANTIALLY EQUIVALENT 1
RELIANCE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
REPUBLIC SPINE, L.L.C.
  SUBSTANTIALLY EQUIVALENT 1
SAPPHIRE MEDICAL GROUP
  SUBSTANTIALLY EQUIVALENT 2
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SILONY MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SOLCO BIOMEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN MEDICAL (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEART
  SUBSTANTIALLY EQUIVALENT 2
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
SPINECRAFT, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 1
TITAN SPINE, INC
  SUBSTANTIALLY EQUIVALENT 2
TYBER MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
U&I CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ULRICH MEDICAL USA
  SUBSTANTIALLY EQUIVALENT 1
ULRICH MEDICAL USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
VY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 5
WENZEL SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
ZSFAB INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 140 140
2020 86 86
2021 161 161
2022 50 50
2023 36 36
2024 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 233 233
Migration 58 58
Fracture 41 41
Break 39 39
Patient Device Interaction Problem 26 26
Malposition of Device 21 21
No Apparent Adverse Event 14 14
Migration or Expulsion of Device 12 12
Insufficient Information 9 9
Material Integrity Problem 7 7
Device-Device Incompatibility 7 7
Device Dislodged or Dislocated 6 6
Unintended Movement 6 6
Appropriate Term/Code Not Available 6 6
Device Slipped 5 5
Physical Resistance/Sticking 4 4
Detachment of Device or Device Component 3 3
Failure to Osseointegrate 3 3
Device Appears to Trigger Rejection 3 3
Material Fragmentation 3 3
Loose or Intermittent Connection 2 2
Material Deformation 2 2
Mechanical Problem 2 2
Expulsion 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Flaked 2 2
Mechanical Jam 2 2
Compatibility Problem 2 2
Solder Joint Fracture 2 2
Separation Problem 1 1
Patient-Device Incompatibility 1 1
Premature Separation 1 1
Unexpected Therapeutic Results 1 1
Activation, Positioning or Separation Problem 1 1
Material Separation 1 1
Loss of or Failure to Bond 1 1
Device Contaminated During Manufacture or Shipping 1 1
Nonstandard Device 1 1
Device Handling Problem 1 1
Product Quality Problem 1 1
Material Protrusion/Extrusion 1 1
Inaccurate Information 1 1
Expiration Date Error 1 1
Human-Device Interface Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 103 103
Dysphagia/ Odynophagia 60 60
No Clinical Signs, Symptoms or Conditions 58 58
Non-union Bone Fracture 46 46
No Code Available 44 44
No Consequences Or Impact To Patient 39 39
Neck Pain 37 37
No Known Impact Or Consequence To Patient 32 32
Failure of Implant 29 29
Nerve Damage 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Inadequate Pain Relief 17 17
Insufficient Information 16 16
Unspecified Infection 16 16
Hematoma 15 15
Cerebrospinal Fluid Leakage 14 14
Numbness 13 13
Post Operative Wound Infection 12 12
Physical Asymmetry 12 12
Unspecified Tissue Injury 10 10
Osteolysis 10 10
Bone Fracture(s) 9 9
Fatigue 8 8
Muscular Rigidity 7 7
Vertebral Fracture 6 6
Intervertebral Disc Compression or Protrusion 6 6
Muscle Weakness 6 6
Joint Disorder 5 5
Calcium Deposits/Calcification 5 5
Hypersensitivity/Allergic reaction 5 5
Reaction 4 4
Implant Pain 4 4
Impaired Healing 4 4
Loss of Range of Motion 4 4
Discomfort 4 4
Patient Problem/Medical Problem 3 3
Decreased Sensitivity 3 3
Fall 3 3
Injury 3 3
Foreign Body In Patient 3 3
Quadriplegia 3 3
Spinal Cord Injury 3 3
Tissue Damage 3 3
Dyspnea 3 3
Device Embedded In Tissue or Plaque 2 2
Nervous System Injury 2 2
Perforation of Vessels 2 2
Pulmonary Embolism 2 2
Paralysis 2 2
Swelling/ Edema 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Medicrea International II Aug-24-2023
2 XTANT Medical III Nov-06-2020
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