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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 2
ACUITY SURGICAL DEVICES LLC
  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 3
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
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 1
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 5
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 SAS
  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
2020 162 162
2021 186 186
2022 200 201
2023 148 148
2024 142 142
2025 120 120

Device Problems MDRs with this Device Problem Events in those MDRs
Break 154 154
Adverse Event Without Identified Device or Use Problem 133 133
Fracture 130 130
Material Integrity Problem 108 108
Migration 59 59
Mechanical Problem 53 53
Patient Device Interaction Problem 53 53
Compatibility Problem 42 42
Difficult to Insert 38 38
Detachment of Device or Device Component 29 29
Material Twisted/Bent 25 25
Insufficient Information 22 22
Physical Resistance/Sticking 18 18
Crack 18 18
Failure to Osseointegrate 16 16
Material Fragmentation 14 14
Device-Device Incompatibility 12 12
Manufacturing, Packaging or Shipping Problem 12 12
Improper or Incorrect Procedure or Method 11 11
Material Deformation 9 9
Activation, Positioning or Separation Problem 8 8
Loss of Osseointegration 8 8
Material Separation 8 8
Use of Device Problem 8 8
Device Dislodged or Dislocated 7 7
Malposition of Device 6 6
Positioning Problem 6 6
Mechanical Jam 5 5
No Apparent Adverse Event 5 5
Loosening of Implant Not Related to Bone-Ingrowth 5 5
Product Quality Problem 4 4
Difficult to Remove 4 4
Unintended Movement 4 4
Patient-Device Incompatibility 4 4
Migration or Expulsion of Device 4 4
Mechanics Altered 3 3
Misassembly by Users 3 3
Premature Separation 3 3
Loose or Intermittent Connection 3 3
Entrapment of Device 3 3
Component Missing 2 2
Device Fell 2 2
Failure to Cut 2 2
Labelling, Instructions for Use or Training Problem 2 2
Separation Failure 2 2
Osseointegration Problem 2 2
Misassembled During Installation 1 1
Scratched Material 1 1
Defective Device 1 1
Positioning Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 491 491
No Consequences Or Impact To Patient 89 89
Insufficient Information 79 79
Pain 55 55
Failure of Implant 53 53
No Known Impact Or Consequence To Patient 52 52
Dysphagia/ Odynophagia 42 43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 40
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
No Code Available 11 11
Physical Asymmetry 9 9
Ossification 9 9
Post Operative Wound Infection 8 8
Spinal Cord Injury 7 7
Cerebrospinal Fluid Leakage 7 7
Hematoma 7 7
Paralysis 7 7
Nerve Damage 7 7
Injury 6 6
Dysphasia 5 5
Airway Obstruction 5 5
Metal Related Pathology 5 5
Unspecified Tissue Injury 5 5
Numbness 5 5
Swelling/ Edema 4 4
Subluxation 4 4
Device Embedded In Tissue or Plaque 3 3
Speech Disorder 3 3
Inadequate Osseointegration 3 3
Unspecified Musculoskeletal problem 3 3
Discomfort 3 3
Quadriplegia 2 2
Hemorrhage/Bleeding 2 2
Stenosis 2 2
Loss of Range of Motion 2 2
Thrombosis/Thrombus 2 2
Unspecified Nervous System Problem 2 2
Patient Problem/Medical Problem 2 2
Unspecified Infection 2 2
Burning Sensation 1 2
Spinal Column Injury 1 1
Neurological Deficit/Dysfunction 1 1
Fall 1 1
Hematemesis 1 1
Cramp(s) /Muscle Spasm(s) 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
4 U&I CORP. II Apr-29-2020
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