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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
AESCULAP IMPLANT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 3
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
AMENDIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
APOLLO SPINE, INC.
  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
BINDER BIOMEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOGENNIX, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET SPINE
  SUBSTANTIALLY EQUIVALENT 2
BIOMET SPINE & BONE HEALING TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 3
CARLSMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
CENTINEL SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
CENTINEL SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 3
CHOICE SPINE, LP
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE SAS
  SUBSTANTIALLY EQUIVALENT 2
CLARIANCE, SAS
  SUBSTANTIALLY EQUIVALENT 2
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
CUSTOM SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
EMINENT SPINE
  SUBSTANTIALLY EQUIVALENT 1
EVOLUTION SPINE
  SUBSTANTIALLY EQUIVALENT 3
FBC DEVICE APS
  SUBSTANTIALLY EQUIVALENT 1
FRONTIER MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 7
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
GS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HD LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 1
INCITE INNOVATION LLC
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 3
K2M
  SUBSTANTIALLY EQUIVALENT 1
K2M INC.
  SUBSTANTIALLY EQUIVALENT 1
K2M, INC
  SUBSTANTIALLY EQUIVALENT 1
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 4
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
LANX, INC.
  SUBSTANTIALLY EQUIVALENT 2
LANX, LLC
  SUBSTANTIALLY EQUIVALENT 1
LDR SPINE USA
  SUBSTANTIALLY EQUIVALENT 1
LDR SPINE USA INC.
  SUBSTANTIALLY EQUIVALENT 2
LDR SPINE USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 2
MEDICREA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC SOFAMOR DANEK USA, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 2
NEUROSTRUCTURES
  SUBSTANTIALLY EQUIVALENT 1
NEUROSTRUCTURES, INC.
  SUBSTANTIALLY EQUIVALENT 2
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 3
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
NOVAPPROACH SPINE
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INC.
  SUBSTANTIALLY EQUIVALENT 4
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 9
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 1
OSSEUS FUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
OSTEO VASIVE LLC
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRO SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RELIANCE MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
RENOVIS SURGICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SIATS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN MEDICAL (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL USA
  SUBSTANTIALLY EQUIVALENT 2
SPINE SMITH PARTNERS L.P.
  SUBSTANTIALLY EQUIVALENT 2
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEART
  SUBSTANTIALLY EQUIVALENT 3
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINEOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 2
THEKEN SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
THEKEN SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
TITAN SPINE, INC
  SUBSTANTIALLY EQUIVALENT 2
TITAN SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
VGI, LLC
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 35 35
2015 43 43
2016 55 55
2017 72 72
2018 112 112
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 408 408
Break 158 158
Migration 114 114
Fracture 68 68
Migration or Expulsion of Device 38 38
No Apparent Adverse Event 36 36
Appropriate Term/Code Not Available 36 36
Patient Device Interaction Problem 31 31
Detachment of Device or Device Component 27 27
Device Dislodged or Dislocated 21 21
Unintended Movement 20 20
Device-Device Incompatibility 19 19
Positioning Problem 18 18
Compatibility Problem 17 17
Malposition of Device 17 17
Insufficient Information 17 17
Mechanical Problem 16 16
Crack 16 16
Material Separation 15 15
Material Deformation 15 15
Material Integrity Problem 15 15
Difficult to Insert 14 14
Material Fragmentation 13 13
Bent 12 12
Disassembly 11 11
Positioning Failure 11 11
Device Slipped 9 9
Device Operates Differently Than Expected 9 9
Activation, Positioning or Separation Problem 8 8
Material Twisted/Bent 8 8
Loss of Osseointegration 7 7
Mechanical Jam 7 7
Use of Device Problem 7 7
Loose or Intermittent Connection 7 7
Device Handling Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Unstable 5 5
Difficult to Remove 4 4
Device Appears to Trigger Rejection 4 4
Failure to Advance 4 4
Component Missing 4 4
Osseointegration Problem 4 4
Off-Label Use 4 4
Biocompatibility 4 4
Disconnection 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Difficult to Advance 3 3
Failure to Align 3 3
Collapse 3 3
Failure to Osseointegrate 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 202 202
Pain 173 173
No Known Impact Or Consequence To Patient 160 160
No Clinical Signs, Symptoms or Conditions 128 128
Non-union Bone Fracture 91 91
Failure of Implant 82 82
No Consequences Or Impact To Patient 65 65
Insufficient Information 49 49
Unspecified Infection 48 48
Nerve Damage 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
No Information 37 37
Post Operative Wound Infection 33 33
Injury 32 32
Unspecified Tissue Injury 31 31
Hematoma 30 30
Osteolysis 29 29
Dysphagia/ Odynophagia 24 24
Bone Fracture(s) 24 24
Impaired Healing 21 21
Device Embedded In Tissue or Plaque 13 13
Cerebrospinal Fluid Leakage 13 13
Perforation of Vessels 13 13
Stenosis 10 10
Paresis 10 10
Foreign Body In Patient 10 10
Weakness 10 10
Blood Loss 9 9
Not Applicable 8 8
Spinal Column Injury 8 8
Hypoesthesia 7 7
Physical Asymmetry 7 7
No Patient Involvement 7 7
Thrombosis 7 7
Malunion of Bone 5 5
Fall 5 5
Neurological Deficit/Dysfunction 5 5
Ossification 5 5
Fatigue 5 5
Inadequate Osseointegration 5 5
Wound Dehiscence 4 4
Abdominal Pain 4 4
Ambulation Difficulties 4 4
Tissue Damage 4 4
Unspecified Nervous System Problem 4 4
Paralysis 4 4
Seroma 4 4
Local Reaction 4 4
Death 4 4
Thrombosis/Thrombus 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Acuity Surgical Devices, LLC II Jun-11-2020
2 Alphatec Spine, Inc. II Feb-23-2024
3 Amendia, Inc II Dec-22-2016
4 Biomet Spine, LLC II Mar-25-2016
5 Biomet Spine, LLC II Jan-15-2015
6 Biomet Spine, LLC II Jan-15-2015
7 Biomet Spine, LLC II Jan-14-2015
8 Lanx, Inc. II Nov-26-2013
9 Medacta Usa Inc II Apr-19-2023
10 Medicrea International II Aug-24-2023
11 Medtronic Sofamor Danek USA Inc II Jul-10-2023
12 Medtronic Sofamor Danek USA Inc II Oct-12-2021
13 Novapproach Spine LLC II Nov-17-2022
14 SPINEART SA II Apr-24-2023
15 VGI Medical, LLC II Jun-05-2018
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