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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, lumbar
Regulation Description Intervertebral body fusion device.
Definition Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Product CodeOVD
Regulation Number 888.3080
Device Class 2


Premarket Reviews
ManufacturerDecision
4WEB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
4WEB, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUITY SURGICAL DEVICES LLC
  SUBSTANTIALLY EQUIVALENT 1
ACUITY SURGICAL DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ASTURA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ATLAS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
AURORA SPINE INC
  SUBSTANTIALLY EQUIVALENT 1
AXIS SPINE TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 2
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CARLSMED, INC.
  SUBSTANTIALLY EQUIVALENT 4
CLARIANCE, SAS
  SUBSTANTIALLY EQUIVALENT 1
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
EMINENT SPINE
  SUBSTANTIALLY EQUIVALENT 1
EVOLUTION SPINE
  SUBSTANTIALLY EQUIVALENT 3
FOUNDATION SURGICAL GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HD LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 2
NEUROSTRUCTURES
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 4
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
NOVAPPROACH SPINE
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 4
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
OSSEUS FUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRO SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN MEDICAL (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 1
SPINEART
  SUBSTANTIALLY EQUIVALENT 1
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TITAN SPINE, INC
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 203 203
2021 221 221
2022 74 74
2023 67 67
2024 94 94
2025 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 312 312
Migration 91 91
Break 48 48
Fracture 34 34
Patient Device Interaction Problem 33 33
Appropriate Term/Code Not Available 26 26
Material Separation 20 20
Detachment of Device or Device Component 18 18
Compatibility Problem 17 17
Device Dislodged or Dislocated 15 15
Device-Device Incompatibility 12 12
Mechanical Problem 11 11
Insufficient Information 11 11
Material Integrity Problem 9 9
Material Fragmentation 9 9
Use of Device Problem 8 8
Loss of Osseointegration 7 7
Migration or Expulsion of Device 7 7
No Apparent Adverse Event 7 7
Malposition of Device 6 6
Biocompatibility 4 4
Activation, Positioning or Separation Problem 4 4
Osseointegration Problem 4 4
Crack 4 4
Positioning Problem 4 4
Material Deformation 4 4
Unstable 3 3
Off-Label Use 3 3
Unintended Movement 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Contamination 3 3
Difficult to Remove 3 3
Material Twisted/Bent 3 3
Failure to Osseointegrate 3 3
Mechanical Jam 2 2
Misassembled 2 2
Difficult to Insert 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Patient-Device Incompatibility 2 2
Collapse 2 2
Entrapment of Device 2 2
Difficult or Delayed Positioning 1 1
Device Damaged by Another Device 1 1
Unintended Ejection 1 1
Device Handling Problem 1 1
Product Quality Problem 1 1
Misassembled During Installation 1 1
Installation-Related Problem 1 1
Expiration Date Error 1 1
Difficult to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 146 146
Pain 122 122
No Code Available 85 85
Non-union Bone Fracture 76 76
Insufficient Information 57 57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 39 39
Nerve Damage 36 36
Failure of Implant 35 35
Unspecified Tissue Injury 31 31
Post Operative Wound Infection 29 29
Unspecified Infection 28 28
Osteolysis 27 27
Hematoma 26 26
Dysphagia/ Odynophagia 21 21
Injury 19 19
Impaired Healing 16 16
Bone Fracture(s) 15 15
Perforation of Vessels 11 11
Cerebrospinal Fluid Leakage 10 10
Stenosis 8 8
Paresis 8 8
Foreign Body In Patient 8 8
Hypoesthesia 7 7
Physical Asymmetry 7 7
No Known Impact Or Consequence To Patient 7 7
Device Embedded In Tissue or Plaque 6 6
Abdominal Pain 6 6
No Consequences Or Impact To Patient 6 6
Spinal Column Injury 6 6
Hypersensitivity/Allergic reaction 5 5
Inadequate Osseointegration 5 5
Fatigue 5 5
Malunion of Bone 5 5
Ossification 5 5
Joint Laxity 4 4
Hernia 4 4
Thrombosis 4 4
Paralysis 4 4
Thrombosis/Thrombus 4 4
Unspecified Nervous System Problem 4 4
Blood Loss 4 4
Cyst(s) 4 4
Excessive Tear Production 3 3
Seroma 3 3
Spinal Cord Injury 3 3
Bacterial Infection 3 3
Inflammation 3 3
Neuropathy 3 3
Tissue Damage 3 3
Speech Disorder 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Acuity Surgical Devices, LLC II Jun-11-2020
2 Alphatec Spine, Inc. II Feb-23-2024
3 Medacta Usa Inc II Apr-19-2023
4 Medicrea International II Aug-24-2023
5 Medtronic Sofamor Danek USA Inc II Jul-10-2023
6 Medtronic Sofamor Danek USA Inc II Oct-12-2021
7 Novapproach Spine LLC II Nov-17-2022
8 SPINEART SA II Apr-24-2023
9 Stryker Spine II Mar-31-2025
10 XTANT Medical Holdings, Inc II Feb-19-2025
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