• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 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 3
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, 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 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
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 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 312 312
Migration 90 90
Break 42 42
Fracture 32 32
Patient Device Interaction Problem 32 32
Appropriate Term/Code Not Available 26 26
Detachment of Device or Device Component 18 18
Compatibility Problem 17 17
Material Separation 16 16
Device Dislodged or Dislocated 14 14
Device-Device Incompatibility 12 12
Insufficient Information 11 11
Mechanical Problem 10 10
Material Fragmentation 9 9
Material Integrity Problem 9 9
Use of Device Problem 8 8
Migration or Expulsion of Device 7 7
No Apparent Adverse Event 7 7
Loss of Osseointegration 7 7
Malposition of Device 6 6
Material Deformation 4 4
Activation, Positioning or Separation Problem 4 4
Osseointegration Problem 4 4
Positioning Problem 4 4
Crack 4 4
Biocompatibility 4 4
Material Twisted/Bent 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Unintended Movement 3 3
Failure to Osseointegrate 3 3
Unstable 3 3
Difficult to Remove 3 3
Off-Label Use 3 3
Collapse 2 2
Contamination 2 2
Misassembled 2 2
Patient-Device Incompatibility 2 2
Entrapment of Device 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Difficult to Insert 2 2
Mechanical Jam 2 2
Failure to Eject 1 1
Product Quality Problem 1 1
Difficult or Delayed Positioning 1 1
Expiration Date Error 1 1
Naturally Worn 1 1
Human-Device Interface Problem 1 1
Difficult to Advance 1 1
Misassembled During Installation 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 135 135
Pain 122 122
No Code Available 85 85
Non-union Bone Fracture 76 76
Insufficient Information 54 54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 39 39
Nerve Damage 35 35
Failure of Implant 32 32
Unspecified Tissue Injury 31 31
Post Operative Wound Infection 29 29
Unspecified Infection 28 28
Osteolysis 27 27
Hematoma 26 26
Dysphagia/ Odynophagia 20 20
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
Physical Asymmetry 7 7
Hypoesthesia 7 7
No Known Impact Or Consequence To Patient 7 7
Foreign Body In Patient 7 7
Device Embedded In Tissue or Plaque 6 6
Abdominal Pain 6 6
Spinal Column Injury 6 6
No Consequences Or Impact To Patient 6 6
Hypersensitivity/Allergic reaction 5 5
Malunion of Bone 5 5
Fatigue 5 5
Inadequate Osseointegration 5 5
Ossification 5 5
Hernia 4 4
Thrombosis/Thrombus 4 4
Unspecified Nervous System Problem 4 4
Joint Laxity 4 4
Cyst(s) 4 4
Paralysis 4 4
Blood Loss 4 4
Thrombosis 4 4
Excessive Tear Production 3 3
Speech Disorder 3 3
Not Applicable 3 3
Spinal Cord Injury 3 3
Tissue Damage 3 3
Seroma 3 3
Neuropathy 3 3
Swelling/ Edema 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
-
-