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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 2
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
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 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 334 334
Migration 107 107
Break 68 68
Fracture 42 42
No Apparent Adverse Event 33 33
Patient Device Interaction Problem 31 31
Appropriate Term/Code Not Available 28 28
Device-Device Incompatibility 19 19
Compatibility Problem 17 17
Detachment of Device or Device Component 16 16
Device Dislodged or Dislocated 14 14
Positioning Problem 12 12
Insufficient Information 11 11
Material Separation 10 10
Mechanical Problem 10 10
Migration or Expulsion of Device 9 9
Material Fragmentation 9 9
Material Integrity Problem 9 9
Material Twisted/Bent 8 8
Loss of Osseointegration 7 7
Use of Device Problem 6 6
Malposition of Device 5 5
Difficult to Insert 5 5
Crack 5 5
Device Appears to Trigger Rejection 4 4
Device Slipped 4 4
Biocompatibility 4 4
Activation, Positioning or Separation Problem 4 4
Osseointegration Problem 4 4
Unintended Movement 4 4
Device Handling Problem 3 3
Material Deformation 3 3
Component Missing 3 3
Difficult to Advance 3 3
Unstable 3 3
Failure to Osseointegrate 3 3
Difficult to Remove 3 3
Off-Label Use 3 3
Entrapment of Device 3 3
Misassembled 2 2
Collapse 2 2
Contamination 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Mechanical Jam 2 2
Naturally Worn 1 1
Installation-Related Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Difficult to Maintain 1 1
Material Split, Cut or Torn 1 1
Failure to Eject 1 1
Misassembled During Installation 1 1
Difficult or Delayed Positioning 1 1
Disconnection 1 1
Loose or Intermittent Connection 1 1
Unintended Ejection 1 1
Product Quality Problem 1 1
Fitting Problem 1 1
Patient-Device Incompatibility 1 1
Expiration Date Error 1 1
Human-Device Interface Problem 1 1
Inadequate User Interface 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 153 153
Pain 133 133
No Clinical Signs, Symptoms or Conditions 113 113
Non-union Bone Fracture 82 82
Insufficient Information 44 44
No Consequences Or Impact To Patient 41 41
Failure of Implant 38 38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Nerve Damage 37 37
No Known Impact Or Consequence To Patient 36 36
Unspecified Infection 33 33
Unspecified Tissue Injury 31 31
Post Operative Wound Infection 29 29
Injury 29 29
Hematoma 28 28
Osteolysis 24 24
Bone Fracture(s) 17 17
Dysphagia/ Odynophagia 17 17
Impaired Healing 14 14
Perforation of Vessels 11 11
Cerebrospinal Fluid Leakage 11 11
Paresis 9 9
Weakness 8 8
Thrombosis 7 7
Stenosis 7 7
Hypoesthesia 7 7
Device Embedded In Tissue or Plaque 7 7
Physical Asymmetry 7 7
No Information 7 7
Blood Loss 6 6
Foreign Body In Patient 6 6
Inadequate Osseointegration 5 5
Spinal Column Injury 5 5
Ossification 5 5
Fatigue 5 5
Malunion of Bone 5 5
Hypersensitivity/Allergic reaction 4 4
Abscess 4 4
Cyst(s) 4 4
Local Reaction 4 4
Paralysis 4 4
No Patient Involvement 4 4
Not Applicable 4 4
Ambulation Difficulties 3 3
Excessive Tear Production 3 3
Hernia 3 3
Tissue Damage 3 3
Loss of Range of Motion 3 3
Seroma 3 3
Neuropathy 3 3
Bacterial Infection 3 3
Hemorrhage/Bleeding 3 3
Wound Dehiscence 3 3
Thrombosis/Thrombus 3 3
Joint Laxity 3 3
Swelling/ Edema 3 3
Calcium Deposits/Calcification 2 2
Arthritis 2 2
Pulmonary Embolism 2 2
Inflammation 2 2
Neurological Deficit/Dysfunction 2 2
Incontinence 2 2
Venipuncture 2 2
Reaction 2 2
Numbness 2 2
Decreased Sensitivity 2 2
Discomfort 2 2
Unspecified Nervous System Problem 2 2
Embolism/Embolus 1 1
Paresthesia 1 1
Fibrosis 1 1
Patient Problem/Medical Problem 1 1
Claudication 1 1
Spinal Cord Injury 1 1
Disability 1 1
Urinary Frequency 1 1
Muscular Rigidity 1 1
Necrosis 1 1
Stroke/CVA 1 1
Fall 1 1
Implant Pain 1 1

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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