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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intervertebral fusion device with integrated fixation, 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 with or without supplemental fixation.
Product CodeOVE
Regulation Number 888.3080
Device Class 2


Premarket Reviews
ManufacturerDecision
4WEB MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
4WEB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
ACUITY SURGICAL DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE IMPLANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BESPOKE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
BLUSTONE SYNERGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CHOICE SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
CLARIANCE
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE, SA
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
DIO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDISONINNO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELEVATION SPINE
  SUBSTANTIALLY EQUIVALENT 1
EMINENT SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
EVOLUTION SPINE
  SUBSTANTIALLY EQUIVALENT 2
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
INNOSYS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NANOHIVE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRO SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAGICO VA USA, LLC
  SUBSTANTIALLY EQUIVALENT 2
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
SIGNUS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN MEDICAL (PTY) , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ANALYTICS & GEOMETRICAL IMPLANT CO, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
SPINEUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION, S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
U&I CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
XENCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 186 186
2022 200 203
2023 148 148
2024 142 142
2025 136 136
2026 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 129 130
Break 119 119
Fracture 103 103
Material Integrity Problem 99 99
Patient Device Interaction Problem 55 56
Migration 50 50
Compatibility Problem 42 42
Mechanical Problem 42 42
Detachment of Device or Device Component 26 26
Insufficient Information 25 25
Difficult to Insert 22 22
Crack 17 17
Failure to Osseointegrate 15 15
Material Fragmentation 14 14
Material Twisted/Bent 13 13
Manufacturing, Packaging or Shipping Problem 12 12
Improper or Incorrect Procedure or Method 11 11
Physical Resistance/Sticking 11 11
Activation, Positioning or Separation Problem 8 8
Loss of Osseointegration 8 8
Material Separation 8 8
Device-Device Incompatibility 7 7
Device Dislodged or Dislocated 7 7
Malposition of Device 6 6
Positioning Problem 6 6
Use of Device Problem 6 6
Material Deformation 6 6
Migration or Expulsion of Device 5 5
Loosening of Implant Not Related to Bone-Ingrowth 5 5
Product Quality Problem 5 5
No Apparent Adverse Event 4 4
Patient-Device Incompatibility 4 4
Difficult to Remove 4 4
Premature Separation 3 3
Misassembly by Users 3 3
Mechanics Altered 3 3
Failure to Cut 2 2
Separation Failure 2 2
Off-Label Use 2 2
Mechanical Jam 2 2
Osseointegration Problem 2 2
Device Damaged by Another Device 1 1
Difficult or Delayed Positioning 1 1
Component Missing 1 1
Positioning Failure 1 1
Device Handling Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Misassembled During Installation 1 1
Scratched Material 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 497 497
Insufficient Information 81 81
Pain 51 51
Failure of Implant 48 48
Dysphagia/ Odynophagia 43 44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 41
Osteolysis 21 21
Neck Pain 20 21
Bone Fracture(s) 18 18
Malunion of Bone 13 13
Non-union Bone Fracture 12 12
Foreign Body In Patient 12 12
Post Operative Wound Infection 11 11
No Consequences Or Impact To Patient 9 9
Physical Asymmetry 9 9
Ossification 9 9
Spinal Cord Injury 7 7
Cerebrospinal Fluid Leakage 7 7
Hematoma 7 7
Paralysis 7 7
Nerve Damage 7 7
Dysphasia 5 5
Airway Obstruction 5 5
Swelling/ Edema 5 5
Unspecified Tissue Injury 5 5
Numbness 5 5
Metal Related Pathology 4 4
Subluxation 4 4
Device Embedded In Tissue or Plaque 3 3
Speech Disorder 3 3
Unspecified Musculoskeletal problem 3 3
Discomfort 3 3
Hemorrhage/Bleeding 2 3
Stenosis 2 2
Loss of Range of Motion 2 2
Thrombosis/Thrombus 2 2
Unspecified Nervous System Problem 2 2
Inadequate Osseointegration 2 2
Unspecified Infection 2 2
Burning Sensation 1 2
Spinal Column Injury 1 1
Hematemesis 1 1
Fall 1 1
Osteopenia/ Osteoporosis 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Implant Pain 1 1
Muscle Weakness 1 1
Nicks, cuts or tears of dura or other tissues by device 1 1
Perforation of Vessels 1 1
Perforation of Esophagus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 K2M, Inc II Oct-13-2021
2 Medtronic Sofamor Danek USA Inc II Oct-12-2021
3 Stryker Spine II Sep-23-2024
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