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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
ACUITY SURGICAL DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 3
ALPHATEC SPINE
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ATLAS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
AURORA SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
AVALIGN TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AXIS SPINE TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CARLSMED, INC.
  SUBSTANTIALLY EQUIVALENT 4
CLARIANCE, SAS
  SUBSTANTIALLY EQUIVALENT 1
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
EMINENT SPINE
  SUBSTANTIALLY EQUIVALENT 1
EVOLUTION SPINE
  SUBSTANTIALLY EQUIVALENT 3
FOUNDATION SURGICAL GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 2
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 4
NOVAPPROACH SPINE
  SUBSTANTIALLY EQUIVALENT 1
NOVAPPROACH SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NU VASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
OSSEUS FUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRO SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SOUTHERN MEDICAL (PTY) , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 221 221
2022 74 75
2023 67 71
2024 92 92
2025 50 50
2026 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 217 217
Migration 56 58
Break 53 53
Fracture 38 38
Material Separation 24 24
Appropriate Term/Code Not Available 23 23
Patient Device Interaction Problem 17 17
Compatibility Problem 15 17
Detachment of Device or Device Component 15 15
Mechanical Problem 13 13
Device Dislodged or Dislocated 11 11
Insufficient Information 11 11
Material Integrity Problem 9 9
Use of Device Problem 9 9
Material Fragmentation 8 8
Malposition of Device 6 6
Material Deformation 6 6
Device-Device Incompatibility 5 5
Positioning Problem 5 5
Biocompatibility 4 4
Activation, Positioning or Separation Problem 4 4
Osseointegration Problem 4 4
Off-Label Use 4 4
Crack 4 4
Loss of Osseointegration 3 3
No Apparent Adverse Event 3 3
Device Damaged by Another Device 3 3
Failure to Osseointegrate 3 3
Difficult to Insert 3 3
Difficult to Remove 3 3
Contamination 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Migration or Expulsion of Device 3 3
Unstable 3 3
Material Twisted/Bent 2 3
Misassembled 2 2
Collapse 2 2
Mechanical Jam 2 2
Entrapment of Device 2 2
Unintended Ejection 1 1
Misassembled During Installation 1 1
Difficult or Delayed Positioning 1 1
Expiration Date Error 1 1
Product Quality Problem 1 1
Defective Component 1 1
Unintended Movement 1 1
Patient-Device Incompatibility 1 1
Device Markings/Labelling Problem 1 1
Failure to Eject 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 168 171
Pain 66 66
Non-union Bone Fracture 65 65
Insufficient Information 64 66
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 40
Nerve Damage 28 28
Unspecified Tissue Injury 28 28
Osteolysis 25 25
Failure of Implant 22 22
Hematoma 22 22
Post Operative Wound Infection 22 22
Dysphagia/ Odynophagia 20 20
Bone Fracture(s) 12 12
Unspecified Infection 11 11
Perforation of Vessels 10 10
Foreign Body In Patient 10 10
Impaired Healing 9 9
Abdominal Pain 8 8
Physical Asymmetry 7 7
Paresis 6 6
Malunion of Bone 5 5
Stenosis 5 5
Paralysis 5 5
Unspecified Nervous System Problem 5 5
Ossification 5 5
Cerebrospinal Fluid Leakage 5 5
Fatigue 5 5
Device Embedded In Tissue or Plaque 5 5
Joint Laxity 4 4
Hypersensitivity/Allergic reaction 4 4
Swelling/ Edema 3 3
Implant Pain 3 3
Seroma 3 3
Inflammation 3 3
Thrombosis/Thrombus 3 3
Bacterial Infection 3 3
Loss of Range of Motion 3 3
Hernia 3 3
Discomfort 3 3
Inadequate Osseointegration 3 3
Speech Disorder 3 3
Spinal Cord Injury 3 3
Vertebral Fracture 3 3
Abscess 3 3
Neuropathy 3 3
Hemorrhage/Bleeding 2 2
Fall 2 2
Numbness 2 2
Paresthesia 2 2
Spinal Column Injury 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Alphatec Spine, Inc. II Feb-23-2024
2 Medacta Usa Inc II Apr-19-2023
3 Medicrea International II Aug-24-2023
4 Medtronic Sofamor Danek USA Inc II Jul-10-2023
5 Medtronic Sofamor Danek USA Inc II Oct-12-2021
6 Novapproach Spine LLC II Nov-17-2022
7 Novapproach Spine, LLC II May-20-2026
8 Omnia Medical II Sep-11-2025
9 Orthofix U.S. LLC III Dec-11-2025
10 SPINEART SA II Apr-24-2023
11 Stryker Spine II Mar-31-2025
12 XTANT Medical Holdings, Inc II Feb-19-2025
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