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TPLC - Total Product Life Cycle
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Device intervertebral fusion device with bone graft, cervical
Regulation Description Intervertebral body fusion device.
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 IMPLANTS, INC
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE INC.
  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
BESPOKE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
BLUSTONE SYNERGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARLSMED, INC
  SUBSTANTIALLY EQUIVALENT 1
CHOICESPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
CTL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
CUTTING EDGE SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEGEN MEDICAL
  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 1
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 2
JMT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
K&J CONSULTING
  SUBSTANTIALLY EQUIVALENT 1
K&J CONSULTING CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KAHTNU SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
KEOS
  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 1
NANOVIS LLC
  SUBSTANTIALLY EQUIVALENT 1
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
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 5
PAONAN BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PARADIGM SPINE
  SUBSTANTIALLY EQUIVALENT 1
RELIANCE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SAPPHIRE MEDICAL GROUP
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  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 1
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
SPINECRAFT, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SPINE
  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
XENCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG DECANS MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZSFAB
  SUBSTANTIALLY EQUIVALENT 1
ZSFAB INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 86 86
2021 161 161
2022 50 50
2023 36 36
2024 55 55
2025 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 192 192
Migration 57 57
Fracture 35 35
Break 27 27
Patient Device Interaction Problem 27 27
Malposition of Device 12 12
No Apparent Adverse Event 10 10
Device-Device Incompatibility 9 9
Migration or Expulsion of Device 9 9
Material Integrity Problem 7 7
Insufficient Information 6 6
Device Slipped 5 5
Loosening of Implant Not Related to Bone-Ingrowth 5 5
Material Deformation 5 5
Appropriate Term/Code Not Available 5 5
Loss of or Failure to Bond 4 4
Physical Resistance/Sticking 4 4
Device Dislodged or Dislocated 4 4
Detachment of Device or Device Component 4 4
Mechanical Problem 3 3
Patient-Device Incompatibility 3 3
Unintended Movement 3 3
Material Fragmentation 3 3
Device Appears to Trigger Rejection 3 3
Expulsion 2 2
Compatibility Problem 2 2
Mechanical Jam 2 2
Flaked 2 2
Corroded 2 2
Inaccurate Information 2 2
Use of Device Problem 2 2
Failure to Osseointegrate 2 2
Solder Joint Fracture 2 2
Loose or Intermittent Connection 1 1
Premature Separation 1 1
Human-Device Interface Problem 1 1
Material Protrusion/Extrusion 1 1
Inadequacy of Device Shape and/or Size 1 1
Material Separation 1 1
Device Handling Problem 1 1
Mechanics Altered 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Expiration Date Error 1 1
Collapse 1 1
Device Markings/Labelling Problem 1 1
Peeled/Delaminated 1 1
Separation Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 92 92
No Clinical Signs, Symptoms or Conditions 88 88
Dysphagia/ Odynophagia 58 58
Non-union Bone Fracture 32 32
No Consequences Or Impact To Patient 32 32
Neck Pain 31 31
Failure of Implant 27 27
Insufficient Information 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Nerve Damage 21 21
Numbness 17 17
Inadequate Pain Relief 17 17
Unspecified Infection 14 14
Hematoma 13 13
Unspecified Tissue Injury 12 12
Physical Asymmetry 12 12
Post Operative Wound Infection 11 11
No Known Impact Or Consequence To Patient 11 11
Osteolysis 10 10
Bone Fracture(s) 10 10
Fatigue 9 9
Swelling/ Edema 8 8
Muscular Rigidity 7 7
Intervertebral Disc Compression or Protrusion 7 7
Vertebral Fracture 6 6
No Code Available 6 6
Fall 5 5
Muscle Weakness 5 5
Implant Pain 5 5
Reaction 4 4
Discomfort 4 4
Perforation of Vessels 4 4
Cerebrospinal Fluid Leakage 4 4
Paresthesia 4 4
Spinal Cord Injury 4 4
Hypersensitivity/Allergic reaction 4 4
Tissue Damage 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Foreign Body In Patient 3 3
Thrombosis/Thrombus 3 3
Inflammation 3 3
Quadriplegia 3 3
Nervous System Injury 3 3
Pulmonary Embolism 3 3
Decreased Sensitivity 3 3
Ambulation Difficulties 3 3
Impaired Healing 3 3
Neck Stiffness 2 2
Arthritis 2 2
Joint Laxity 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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