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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
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, INC.
  SUBSTANTIALLY EQUIVALENT 2
4WEB, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE IMPLANTS, INC
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ATLAS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BESPOKE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
BLUSTONE SYNERGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
CHOICESPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
CLARIANCE
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE, SA
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 2
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 1
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 2
GS MEDICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
HUVEXEL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
INNOSYS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 2
MEDICREA INTERNATIONAL S. A.
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NANOHIVE MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
NEUROSTRUCTURES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAGICO VA USA, LLC
  SUBSTANTIALLY EQUIVALENT 2
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
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 SAS
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION, S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
TITAN SPINE, INC
  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
2019 169 169
2020 162 162
2021 192 192
2022 200 200
2023 150 150
2024 96 96

Device Problems MDRs with this Device Problem Events in those MDRs
Break 161 161
Adverse Event Without Identified Device or Use Problem 160 160
Fracture 120 120
Material Integrity Problem 102 102
Migration 52 52
Mechanical Problem 51 51
Difficult to Insert 40 40
Patient Device Interaction Problem 39 39
Detachment of Device or Device Component 38 38
Compatibility Problem 38 38
Material Twisted/Bent 35 35
Insufficient Information 33 33
Physical Resistance/Sticking 24 24
Crack 20 20
Device-Device Incompatibility 17 17
Improper or Incorrect Procedure or Method 11 11
Positioning Problem 11 11
Failure to Osseointegrate 11 11
Material Fragmentation 10 10
Use of Device Problem 9 9
Manufacturing, Packaging or Shipping Problem 8 8
Loss of Osseointegration 8 8
Appropriate Term/Code Not Available 8 8
Material Deformation 8 8
Activation, Positioning or Separation Problem 7 7
Mechanical Jam 7 7
No Apparent Adverse Event 6 6
Malposition of Device 6 6
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Unintended Movement 5 5
Device Dislodged or Dislocated 5 5
Migration or Expulsion of Device 5 5
Difficult to Remove 4 4
Component Missing 3 3
Defective Component 3 3
Entrapment of Device 3 3
Loose or Intermittent Connection 3 3
Misassembly by Users 3 3
Device Slipped 2 2
Device Fell 2 2
Separation Failure 2 2
Device Difficult to Maintain 2 2
Complete Blockage 2 2
Device Damaged by Another Device 2 2
Installation-Related Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Premature Separation 2 2
Partial Blockage 2 2
Positioning Failure 1 1
Failure to Cut 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 391 391
No Consequences Or Impact To Patient 138 138
No Known Impact Or Consequence To Patient 111 111
Insufficient Information 53 53
Failure of Implant 46 46
Dysphagia/ Odynophagia 45 45
Pain 42 42
No Code Available 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Neck Pain 23 23
Osteolysis 21 21
Bone Fracture(s) 20 20
Non-union Bone Fracture 15 15
Foreign Body Sensation in Eye 12 12
Nerve Damage 12 12
Paralysis 11 11
Hematoma 10 10
Foreign Body In Patient 9 9
Ossification 9 9
Physical Asymmetry 9 9
Cerebrospinal Fluid Leakage 8 8
Unspecified Tissue Injury 8 8
Swollen Glands 8 8
Malunion of Bone 8 8
Post Operative Wound Infection 8 8
Quadriplegia 7 7
No Information 6 6
Injury 6 6
Unspecified Infection 6 6
Burning Sensation 5 5
Airway Obstruction 5 5
No Patient Involvement 5 5
Dysphasia 5 5
Swelling/ Edema 4 4
Subluxation 4 4
Swollen Lymph Nodes 4 4
Patient Problem/Medical Problem 4 4
Unspecified Musculoskeletal problem 3 3
Spinal Cord Injury 3 3
Hemorrhage/Bleeding 2 2
Discomfort 2 2
Numbness 2 2
Loss of Range of Motion 2 2
Thrombosis/Thrombus 2 2
Spinal Column Injury 2 2
Neurological Deficit/Dysfunction 2 2
Inadequate Osseointegration 2 2
Speech Disorder 2 2
Swelling 1 1
Unspecified Nervous System Problem 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 SpineFrontier, Inc. II Jul-12-2019
4 Stryker Spine II Sep-23-2024
5 U&I CORP. II Apr-29-2020
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