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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
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
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 1
JMT CO., LTD
  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 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 182 182
Migration 51 51
Fracture 32 32
Patient Device Interaction Problem 26 26
Break 20 20
Malposition of Device 11 11
No Apparent Adverse Event 10 10
Migration or Expulsion of Device 8 8
Material Integrity Problem 7 7
Device-Device Incompatibility 7 7
Insufficient Information 6 6
Appropriate Term/Code Not Available 5 5
Device Slipped 5 5
Physical Resistance/Sticking 4 4
Detachment of Device or Device Component 4 4
Device Dislodged or Dislocated 4 4
Material Fragmentation 3 3
Loss of or Failure to Bond 3 3
Device Appears to Trigger Rejection 3 3
Unintended Movement 3 3
Flaked 2 2
Expulsion 2 2
Mechanical Problem 2 2
Compatibility Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Solder Joint Fracture 2 2
Mechanical Jam 2 2
Failure to Osseointegrate 2 2
Loose or Intermittent Connection 1 1
Peeled/Delaminated 1 1
Collapse 1 1
Patient-Device Incompatibility 1 1
Premature Separation 1 1
Device Contaminated During Manufacture or Shipping 1 1
Activation, Positioning or Separation Problem 1 1
Material Separation 1 1
Mechanics Altered 1 1
Inadequacy of Device Shape and/or Size 1 1
Separation Problem 1 1
Inaccurate Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Expiration Date Error 1 1
Human-Device Interface Problem 1 1
Device Handling Problem 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 89 89
No Clinical Signs, Symptoms or Conditions 64 64
Dysphagia/ Odynophagia 55 55
No Consequences Or Impact To Patient 32 32
Non-union Bone Fracture 30 30
Neck Pain 28 28
Failure of Implant 25 25
Insufficient Information 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Nerve Damage 17 17
Numbness 16 16
Inadequate Pain Relief 15 15
Unspecified Infection 13 13
Hematoma 13 13
Physical Asymmetry 12 12
Unspecified Tissue Injury 11 11
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
Intervertebral Disc Compression or Protrusion 7 7
Muscular Rigidity 7 7
Vertebral Fracture 6 6
Swelling/ Edema 6 6
No Code Available 6 6
Fall 5 5
Implant Pain 5 5
Perforation of Vessels 4 4
Spinal Cord Injury 4 4
Reaction 4 4
Hypersensitivity/Allergic reaction 4 4
Muscle Weakness 4 4
Discomfort 4 4
Cerebrospinal Fluid Leakage 4 4
Foreign Body In Patient 3 3
Impaired Healing 3 3
Thrombosis/Thrombus 3 3
Decreased Sensitivity 3 3
Tissue Damage 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Pulmonary Embolism 3 3
Ambulation Difficulties 3 3
Nervous System Injury 3 3
Quadriplegia 3 3
Inflammation 3 3
Scar Tissue 2 2
Joint Laxity 2 2
Anemia 2 2
Arthritis 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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