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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 2
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
ZHEJIANG DECANS MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 186 186
2022 200 203
2023 148 148
2024 142 142
2025 136 136
2026 43 43

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 130 131
Break 122 122
Fracture 108 108
Material Integrity Problem 100 100
Patient Device Interaction Problem 55 56
Migration 53 53
Mechanical Problem 43 43
Compatibility Problem 42 42
Detachment of Device or Device Component 31 31
Insufficient Information 25 25
Difficult to Insert 22 22
Crack 17 17
Failure to Osseointegrate 15 15
Material Fragmentation 14 14
Manufacturing, Packaging or Shipping Problem 13 13
Material Twisted/Bent 13 13
Physical Resistance/Sticking 11 11
Improper or Incorrect Procedure or Method 11 11
Loss of Osseointegration 8 8
Material Separation 8 8
Activation, Positioning or Separation Problem 8 8
Material Deformation 7 7
Device-Device Incompatibility 7 7
Device Dislodged or Dislocated 7 7
Use of Device Problem 6 6
Malposition of Device 6 6
Positioning Problem 6 6
Osseointegration Problem 5 5
Loosening of Implant Not Related to Bone-Ingrowth 5 5
Patient-Device Incompatibility 5 5
Migration or Expulsion of Device 5 5
Product Quality Problem 5 5
Difficult to Remove 4 4
No Apparent Adverse Event 4 4
Premature Separation 3 3
Mechanical Jam 3 3
Mechanics Altered 3 3
Misassembly by Users 3 3
Off-Label Use 2 2
Separation Failure 2 2
Failure to Cut 2 2
Defective Device 1 1
Device Damaged Prior to Use 1 1
Component Missing 1 1
Expulsion 1 1
Device Damaged by Another Device 1 1
Material Puncture/Hole 1 1
Unintended Collision 1 1
Accessory Incompatible 1 1
Device Appears to Trigger Rejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 516 516
Insufficient Information 85 85
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
Foreign Body In Patient 13 13
Non-union Bone Fracture 12 12
Post Operative Wound Infection 11 11
No Consequences Or Impact To Patient 9 9
Physical Asymmetry 9 9
Ossification 9 9
Nerve Damage 8 8
Spinal Cord Injury 7 7
Cerebrospinal Fluid Leakage 7 7
Hematoma 7 7
Paralysis 7 7
Dysphasia 5 5
Airway Obstruction 5 5
Inadequate Osseointegration 5 5
Swelling/ Edema 5 5
Unspecified Tissue Injury 5 5
Numbness 5 5
Unspecified Infection 4 4
Metal Related Pathology 4 4
Subluxation 4 4
Device Embedded In Tissue or Plaque 3 3
Discomfort 3 3
Unspecified Musculoskeletal problem 3 3
Speech Disorder 3 3
Loss of Range of Motion 2 2
Thrombosis/Thrombus 2 2
Unspecified Nervous System Problem 2 2
Stenosis 2 2
Hemorrhage/Bleeding 2 3
Burning Sensation 1 2
Spinal Column Injury 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Fall 1 1
Hematemesis 1 1
Renal Impairment 1 1
Osteopenia/ Osteoporosis 1 1
Implant Pain 1 1
Abscess 1 1
Muscle Weakness 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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