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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, cervical
Definition Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Product CodeOVE
Regulation Number 888.3080
Device Class 2


Premarket Reviews
ManufacturerDecision
4WEB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
4WEB, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE IMPLANTS, INC
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP IMPLANT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMENDIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
APOLLO SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ATLAS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BESPOKE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET SPINE
  SUBSTANTIALLY EQUIVALENT 2
BLUSTONE SYNERGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
CENTINEL SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 4
CHOICE SPINE, LP
  SUBSTANTIALLY EQUIVALENT 2
CHOICE SPINE, LP.
  SUBSTANTIALLY EQUIVALENT 1
CHOICESPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
CLARIANCE
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE, SA
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 2
CTL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DIO MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
EBI, LLC
  SUBSTANTIALLY EQUIVALENT 1
EDISONINNO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELEVATION SPINE
  SUBSTANTIALLY EQUIVALENT 1
EMINENT SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 5
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
HUVEXEL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
INCITE INNOVATION
  SUBSTANTIALLY EQUIVALENT 1
INCITE INNOVATION LLC
  SUBSTANTIALLY EQUIVALENT 2
INNOSYS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
LANX, INC
  SUBSTANTIALLY EQUIVALENT 1
LDR SPINE USA
  SUBSTANTIALLY EQUIVALENT 2
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE, INC
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE, INC.
  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
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NANOHIVE MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
NEUROSTRUCTURES, INC.
  SUBSTANTIALLY EQUIVALENT 2
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 2
PIONEER SURGICAL TECHNOLOGY, INC. DBA RTI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY,INC. DBA RTI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROVIDENCE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
RHAUSLER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAFE ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
SAGICO VA USA, LLC
  SUBSTANTIALLY EQUIVALENT 2
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
SEASPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN MEDICAL (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ANALYTICS & GEOMETRICAL IMPLANT CO, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINAL USA
  SUBSTANTIALLY EQUIVALENT 1
SPINE SMITH PARTNERS L.P.
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINEART
  SUBSTANTIALLY EQUIVALENT 2
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPINESMITH HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINEUP INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION SAS
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION, S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES SPINE
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES SPINE CO.LP
  SUBSTANTIALLY EQUIVALENT 3
THEKEN SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
TITAN SPINE, INC
  SUBSTANTIALLY EQUIVALENT 1
TITAN SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 3
U&I CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
X-SPINE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
XENCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 150 150
2015 173 173
2016 145 145
2017 134 134
2018 210 210
2019 169 169
2020 162 162
2021 192 192
2022 200 200
2023 150 150
2024 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Break 453 453
Adverse Event Without Identified Device or Use Problem 257 257
Fracture 141 141
Material Integrity Problem 103 103
Detachment of Device or Device Component 71 71
Mechanical Problem 69 69
Difficult to Insert 60 60
Material Twisted/Bent 60 60
Migration 53 53
Crack 53 53
Migration or Expulsion of Device 50 50
Device Operates Differently Than Expected 47 47
Insufficient Information 41 41
Patient Device Interaction Problem 38 38
Device Slipped 37 37
Compatibility Problem 34 34
Detachment Of Device Component 32 32
Material Fragmentation 28 28
Unintended Movement 27 27
Device Dislodged or Dislocated 27 27
Physical Resistance/Sticking 23 23
Positioning Problem 23 23
Malposition of Device 20 20
Bent 20 20
Device-Device Incompatibility 19 19
Improper or Incorrect Procedure or Method 18 18
Material Separation 17 17
Loose or Intermittent Connection 17 17
Fitting Problem 16 16
Mechanical Jam 14 14
Failure To Adhere Or Bond 14 14
Difficult to Remove 13 13
Component Missing 13 13
Activation, Positioning or Separation Problem 12 12
Appropriate Term/Code Not Available 12 12
Material Deformation 12 12
Use of Device Problem 11 11
Failure to Osseointegrate 11 11
Difficult to Advance 10 10
No Apparent Adverse Event 9 9
Failure to Advance 8 8
Loss of Osseointegration 8 8
Manufacturing, Packaging or Shipping Problem 7 7
Component Falling 6 6
Entrapment of Device 6 6
Peeled/Delaminated 6 6
Positioning Failure 5 5
Dull, Blunt 5 5
Unstable 5 5
Defective Component 4 4
Device Damaged Prior to Use 4 4
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Partial Blockage 4 4
Sticking 3 3
Device Damaged by Another Device 3 3
Misassembly by Users 3 3
Disconnection 3 3
Naturally Worn 3 3
Device Fell 3 3
Patient-Device Incompatibility 3 3
Disassembly 3 3
Device Difficult to Maintain 2 2
Connection Problem 2 2
Packaging Problem 2 2
Failure to Align 2 2
Split 2 2
Premature Separation 2 2
Material Erosion 2 2
Scratched Material 2 2
Material Distortion 2 2
Installation-Related Problem 2 2
Material Protrusion/Extrusion 2 2
Human Factors Issue 2 2
Complete Blockage 2 2
Inadequacy of Device Shape and/or Size 2 2
Unintended Collision 1 1
Device Contamination with Chemical or Other Material 1 1
Inappropriate Tactile Prompt/Feedback 1 1
Inaccurate Information 1 1
Device Issue 1 1
Component Incompatible 1 1
Component or Accessory Incompatibility 1 1
Separation Failure 1 1
Expulsion 1 1
Mechanics Altered 1 1
Flaked 1 1
Device Markings/Labelling Problem 1 1
Torn Material 1 1
Labelling, Instructions for Use or Training Problem 1 1
Noise, Audible 1 1
Device Or Device Fragments Location Unknown 1 1
Difficult or Delayed Positioning 1 1
Material Frayed 1 1
Component Misassembled 1 1
Failure to Cut 1 1
Deformation Due to Compressive Stress 1 1
Material Puncture/Hole 1 1
Incorrect Measurement 1 1
Misassembled During Installation 1 1
Material Disintegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 517 517
No Clinical Signs, Symptoms or Conditions 353 353
No Consequences Or Impact To Patient 230 230
No Code Available 159 159
Failure of Implant 92 92
Pain 88 88
Dysphagia/ Odynophagia 72 72
Insufficient Information 44 44
No Information 40 40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
No Patient Involvement 36 36
Neck Pain 31 31
Bone Fracture(s) 24 24
Sedation 22 22
Osteolysis 21 21
Non-union Bone Fracture 21 21
Foreign Body In Patient 20 20
Hematoma 19 19
Injury 17 17
Impaired Healing 17 17
Cerebrospinal Fluid Leakage 16 16
Nerve Damage 15 15
Unspecified Infection 13 13
Paralysis 12 12
Foreign Body Sensation in Eye 12 12
Patient Problem/Medical Problem 11 11
Device Embedded In Tissue or Plaque 10 10
Physical Asymmetry 9 9
Ossification 9 9
Post Operative Wound Infection 8 8
Quadriplegia 8 8
Swollen Glands 8 8
Unspecified Tissue Injury 8 8
Malunion of Bone 8 8
Stenosis 6 6
Dysphasia 6 6
Discomfort 6 6
Neurological Deficit/Dysfunction 6 6
Burning Sensation 5 5
Airway Obstruction 5 5
Not Applicable 5 5
Spinal Cord Injury 5 5
Loss of Range of Motion 4 4
Swollen Lymph Nodes 4 4
Swelling 4 4
Subluxation 4 4
Swelling/ Edema 4 4
Erosion 3 3
Irritation 3 3
Numbness 3 3
Inadequate Osseointegration 3 3
Weakness 3 3
Unspecified Musculoskeletal problem 3 3
Reaction 2 2
Perforation of Vessels 2 2
Spinal Column Injury 2 2
Muscle Weakness 2 2
Nausea 2 2
Thrombosis/Thrombus 2 2
Calcium Deposits/Calcification 2 2
Headache 2 2
Dizziness 2 2
Speech Disorder 2 2
Hypersensitivity/Allergic reaction 2 2
Fall 2 2
Hypoesthesia 2 2
Limited Mobility Of The Implanted Joint 2 2
Hemorrhage/Bleeding 2 2
Tinnitus 1 1
Unspecified Nervous System Problem 1 1
Tingling 1 1
Necrosis 1 1
Edema 1 1
Scarring 1 1
Paraplegia 1 1
Vertebral Fracture 1 1
Blood Loss 1 1
Osteopenia/ Osteoporosis 1 1
Rash 1 1
Autoimmune Reaction 1 1
Decreased Sensitivity 1 1
Metal Related Pathology 1 1
Paresis 1 1
Inflammation 1 1
Hematemesis 1 1
Foreign Body Reaction 1 1
Abdominal Pain 1 1
Joint Dislocation 1 1
Perforation of Esophagus 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Sore Throat 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Amendia, Inc II Jan-04-2018
2 Amendia, Inc II Jan-09-2017
3 Ebi, Llc II Dec-24-2014
4 Exactech, Inc. II Feb-13-2016
5 K2M, Inc II Oct-13-2021
6 Medtronic Sofamor Danek USA Inc II Oct-12-2021
7 SpineFrontier, Inc. II Jul-12-2019
8 Synthes USA HQ, Inc. II Dec-05-2013
9 TITAN SPINE, LLC II Aug-03-2015
10 TITAN SPINE, LLC II Mar-26-2015
11 U&I CORP. II Apr-29-2020
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