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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
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 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
AURORA SPINE INC
  SUBSTANTIALLY EQUIVALENT 1
AXIS SPINE TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 2
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CARLSMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE SAS
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE, SAS
  SUBSTANTIALLY EQUIVALENT 2
EMINENT SPINE
  SUBSTANTIALLY EQUIVALENT 1
EVOLUTION SPINE
  SUBSTANTIALLY EQUIVALENT 3
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HD LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 2
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 2
NEUROSTRUCTURES
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 3
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
RELIANCE MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN MEDICAL (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 1
SPINEART
  SUBSTANTIALLY EQUIVALENT 2
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TITAN SPINE, INC
  SUBSTANTIALLY EQUIVALENT 2
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 171 171
2020 203 203
2021 221 221
2022 74 74
2023 67 67
2024 74 74

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 355 355
Migration 111 111
Break 69 69
Fracture 44 44
No Apparent Adverse Event 33 33
Patient Device Interaction Problem 31 31
Appropriate Term/Code Not Available 28 28
Detachment of Device or Device Component 20 20
Device-Device Incompatibility 19 19
Compatibility Problem 17 17
Material Separation 15 15
Device Dislodged or Dislocated 14 14
Insufficient Information 13 13
Positioning Problem 12 12
Mechanical Problem 10 10
Material Fragmentation 10 10
Migration or Expulsion of Device 9 9
Material Integrity Problem 9 9
Material Twisted/Bent 8 8
Loss of Osseointegration 7 7
Malposition of Device 7 7
Use of Device Problem 6 6
Difficult to Insert 6 6
Crack 5 5
Material Deformation 4 4
Device Appears to Trigger Rejection 4 4
Unintended Movement 4 4
Osseointegration Problem 4 4
Activation, Positioning or Separation Problem 4 4
Biocompatibility 4 4
Device Slipped 4 4
Difficult to Remove 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Component Missing 3 3
Difficult to Advance 3 3
Failure to Osseointegrate 3 3
Off-Label Use 3 3
Device Handling Problem 3 3
Entrapment of Device 3 3
Unstable 3 3
Contamination 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Mechanical Jam 2 2
Collapse 2 2
Misassembled 2 2
Naturally Worn 1 1
Loose or Intermittent Connection 1 1
Human-Device Interface Problem 1 1
Inadequate User Interface 1 1
Installation-Related Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 153 153
Pain 146 146
No Clinical Signs, Symptoms or Conditions 128 128
Non-union Bone Fracture 83 83
Insufficient Information 49 49
No Consequences Or Impact To Patient 41 41
Failure of Implant 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Nerve Damage 38 38
No Known Impact Or Consequence To Patient 36 36
Unspecified Infection 35 35
Unspecified Tissue Injury 31 31
Hematoma 30 30
Injury 29 29
Post Operative Wound Infection 29 29
Osteolysis 27 27
Dysphagia/ Odynophagia 21 21
Bone Fracture(s) 19 19
Impaired Healing 16 16
Cerebrospinal Fluid Leakage 13 13
Perforation of Vessels 11 11
Paresis 9 9
Stenosis 8 8
Weakness 8 8
No Information 7 7
Thrombosis 7 7
Physical Asymmetry 7 7
Hypoesthesia 7 7
Device Embedded In Tissue or Plaque 7 7
Blood Loss 6 6
Spinal Column Injury 6 6
Foreign Body In Patient 6 6
Malunion of Bone 5 5
Inadequate Osseointegration 5 5
Fatigue 5 5
Ossification 5 5
Abscess 4 4
No Patient Involvement 4 4
Hernia 4 4
Joint Laxity 4 4
Thrombosis/Thrombus 4 4
Abdominal Pain 4 4
Paralysis 4 4
Unspecified Nervous System Problem 4 4
Local Reaction 4 4
Hypersensitivity/Allergic reaction 4 4
Not Applicable 4 4
Cyst(s) 4 4
Ambulation Difficulties 3 3
Excessive Tear Production 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
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