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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 bone graft, lumbar
Definition Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Product CodeMAX
Regulation Number 888.3080
Device Class 2


Premarket Reviews
ManufacturerDecision
4WEB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
4WEB, INC.
  SUBSTANTIALLY EQUIVALENT 3
ADVANCED RESEARCH MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
AEGIS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 7
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 5
AMPLIFY SURGICAL INC
  SUBSTANTIALLY EQUIVALENT 1
AMPLIFY SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ASTURA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 3
ATLAS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAAT MEDICAL PRODUCTS BV
  SUBSTANTIALLY EQUIVALENT 1
BAUI BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BENVENUE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIEDERMANN MOTECH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
BIOGENNIX, LLC
  SUBSTANTIALLY EQUIVALENT 1
BLUESTONE SYNERGY
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 3
CAMBER SPINE TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAPTIVA SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARLSMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
CENTINEL SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHOICE SPINE, LP.
  SUBSTANTIALLY EQUIVALENT 1
CHOICESPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE SAS
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE, SAS
  SUBSTANTIALLY EQUIVALENT 2
COLIGNE, AG
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 2
CORENTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CTL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CURITEVA, LLC
  SUBSTANTIALLY EQUIVALENT 1
CUTTING EDGE SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 4
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
DEPUY SYNTHES SPINE
  SUBSTANTIALLY EQUIVALENT 1
DIFUSION TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
DOUBLE MEDICAL TECHNOLOGY INC
  SUBSTANTIALLY EQUIVALENT 1
EIT EMERGING IMPLANT TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 5
ENZTEC LIMITED
  SUBSTANTIALLY EQUIVALENT 1
EXPANDING INNOVATIONS, INC
  SUBSTANTIALLY EQUIVALENT 2
EXPANDING INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXPANDING ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FACETLINK DBA LINKSPINE
  SUBSTANTIALLY EQUIVALENT 1
FIMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FLOSPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
GBS COMMONWEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 3
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 6
HD LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 1
HT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
HUVEXEL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 4
INNOVASIVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRITY IMPLANTS INC
  SUBSTANTIALLY EQUIVALENT 3
INTEGRITY IMPLANTS INC.
  SUBSTANTIALLY EQUIVALENT 4
INTELIVATION LLC
  SUBSTANTIALLY EQUIVALENT 1
JOIMAX GMBH
  SUBSTANTIALLY EQUIVALENT 1
K2M
  SUBSTANTIALLY EQUIVALENT 1
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 4
KALITEC MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
KEOS
  SUBSTANTIALLY EQUIVALENT 2
KUROS BIOSCIENCES BV
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
LEGEND SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 10
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 4
MEDACTA INERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S .A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL DESIGNS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 6
MEDITECH SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC SOFAMOR DANEK USA
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 7
MEDTRONIC SOFAMOR DANEK, USA INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 5
MET ONE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 3
NANOVIS LLC
  SUBSTANTIALLY EQUIVALENT 1
NEO MEDICAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
NEUROSTRUCTURES, INC.
  SUBSTANTIALLY EQUIVALENT 3
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 3
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 4
NGMEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 18
NVISION BIOMEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX US LLC
  SUBSTANTIALLY EQUIVALENT 1
OSSEUS FUSION SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
PANTHEON SPINAL
  SUBSTANTIALLY EQUIVALENT 2
PAONAN BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PARADIGM SPINE, GMBH
  SUBSTANTIALLY EQUIVALENT 1
PINNACLE SPINE GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC. DBA RTI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC., DBA RTI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRECIFIT MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
PRINTERPREZZ
  SUBSTANTIALLY EQUIVALENT 1
PRISM SURGICAL DESIGNS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
RAED M. ALI, M.D., INC.
  SUBSTANTIALLY EQUIVALENT 1
RAED M. ALI, MD., INC.
  SUBSTANTIALLY EQUIVALENT 1
RELIANCE MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
RELIANCE MEDICAL SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 1
RELIANCE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
REPUBLIC SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
RTI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RTI SURGICAL, INC. DBA RTI BIOLOGICS
  SUBSTANTIALLY EQUIVALENT 1
RUBICON SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 14
SHANGHAI SANYOU MEDICAL CO, LTD
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIGNUS MEDIZINTECHNIK
  SUBSTANTIALLY EQUIVALENT 1
SILONY MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 4
SOLCO BIOMEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
SPINAL ANALYTICS & GEOMETRICAL IMPANT CO, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS INC
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINAL ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPINAL STABILITY, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEART
  SUBSTANTIALLY EQUIVALENT 2
SPINEEX INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINEEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEMED GES.M.B.H
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY INC
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 7
SPINEVISION SAS
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION, SAS
  SUBSTANTIALLY EQUIVALENT 1
SPINEWORXX AG
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 2
SUMMIT SPINE
  SUBSTANTIALLY EQUIVALENT 1
TITAN SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
TRANS1
  SUBSTANTIALLY EQUIVALENT 1
U&I CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
VALLUM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VERTERA, INC.
  SUBSTANTIALLY EQUIVALENT 1
VY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
WENZEL SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
XENCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
XENCO MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 3
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 4
ZAVATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 595 595
2018 614 614
2019 699 699
2020 640 640
2021 621 621
2022 250 250

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1094 1094
Adverse Event Without Identified Device or Use Problem 474 474
Migration 362 362
Fracture 247 247
Migration or Expulsion of Device 225 225
Device-Device Incompatibility 200 200
Material Integrity Problem 105 105
Compatibility Problem 88 88
Mechanical Jam 87 87
Material Deformation 66 66
Mechanical Problem 64 64
Collapse 62 62
Appropriate Term/Code Not Available 53 53
Device Dislodged or Dislocated 52 52
Detachment of Device or Device Component 51 51
Device Operates Differently Than Expected 50 50
Insufficient Information 49 49
Material Fragmentation 48 48
Malposition of Device 43 43
Unintended Movement 41 41
Crack 33 33
Material Twisted/Bent 30 30
Difficult to Insert 25 25
Physical Resistance/Sticking 24 24
Use of Device Problem 23 23
No Apparent Adverse Event 22 22
Mechanics Altered 22 22
Improper or Incorrect Procedure or Method 21 21
Detachment Of Device Component 20 20
Patient Device Interaction Problem 20 20
Loosening of Implant Not Related to Bone-Ingrowth 17 17
Positioning Problem 16 16
Loose or Intermittent Connection 16 16
Device Slipped 16 16
Device Handling Problem 15 15
Difficult to Remove 12 12
Fitting Problem 11 11
Inadequacy of Device Shape and/or Size 9 9
Patient-Device Incompatibility 9 9
Separation Failure 9 9
Material Separation 8 8
Material Disintegration 8 8
Device Damaged by Another Device 7 7
Device Sensing Problem 6 6
Material Protrusion/Extrusion 6 6
Disassembly 6 6
Bent 6 6
Biocompatibility 6 6
Device Issue 5 5
Unstable 5 5
Failure to Osseointegrate 5 5
Difficult or Delayed Positioning 5 5
Positioning Failure 5 5
Activation, Positioning or SeparationProblem 5 5
Device Operational Issue 5 5
Device Markings/Labelling Problem 5 5
Difficult to Advance 4 4
Installation-Related Problem 4 4
Human Factors Issue 4 4
Inaccurate Information 4 4
Entrapment of Device 4 4
Material Erosion 4 4
Off-Label Use 4 4
Sticking 4 4
Failure to Align 4 4
Failure to Advance 3 3
Defective Device 3 3
Contamination /Decontamination Problem 3 3
Product Quality Problem 3 3
Nonstandard Device 3 3
Imprecision 3 3
Component Falling 3 3
Device Difficult to Maintain 3 3
Connection Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Osseointegration Problem 2 2
Output Problem 2 2
Packaging Problem 2 2
Naturally Worn 2 2
Failure to Disconnect 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Expulsion 2 2
Missing Value Reason 2 2
Material Split, Cut or Torn 2 2
Device Fell 2 2
Separation Problem 2 2
Disconnection 2 2
Labelling, Instructions for Use or Training Problem 2 2
Loss of Osseointegration 2 2
Component Missing 2 2
Device Damaged Prior to Use 2 2
Defective Component 1 1
Microbial Contamination of Device 1 1
Metal Shedding Debris 1 1
Unexpected Therapeutic Results 1 1
Problem with Sterilization 1 1
Retraction Problem 1 1
Solder Joint Fracture 1 1
Failure to Infuse 1 1
Split 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 977 977
No Clinical Signs, Symptoms or Conditions 616 616
No Code Available 373 373
No Consequences Or Impact To Patient 346 346
Pain 335 335
Failure of Implant 160 160
Injury 120 120
Device Embedded In Tissue or Plaque 93 93
No Information 83 83
Unspecified Infection 80 80
Insufficient Information 75 75
No Patient Involvement 70 70
Foreign Body In Patient 65 65
Hematoma 42 42
Nerve Damage 38 38
Unspecified Tissue Injury 36 36
Bone Fracture(s) 34 34
Non-union Bone Fracture 33 33
Post Operative Wound Infection 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
Patient Problem/Medical Problem 22 22
Osteolysis 22 22
Numbness 22 22
Cerebrospinal Fluid Leakage 22 22
Neuropathy 22 22
Tissue Damage 18 18
Weakness 17 17
Neurological Deficit/Dysfunction 16 16
Hemorrhage/Bleeding 16 16
Blood Loss 15 15
Not Applicable 14 14
Spinal Column Injury 14 14
Perforation of Vessels 13 13
Damage to Ligament(s) 13 13
Stenosis 12 12
Vertebral Fracture 11 11
Discomfort 9 9
Paralysis 9 9
Wound Dehiscence 9 9
Hypersensitivity/Allergic reaction 8 8
Death 8 8
Dysphagia/ Odynophagia 8 8
Fall 8 8
Headache 8 8
Excessive Tear Production 8 8
Inadequate Osseointegration 8 8
Spinal Cord Injury 7 7
Laceration(s) 7 7
Inflammation 7 7
Swelling 7 7
Cyst(s) 7 7
Aspiration/Inhalation 6 6
Inadequate Pain Relief 6 6
Hypoesthesia 6 6
Unspecified Nervous System Problem 6 6
Bowel Perforation 5 5
Decreased Sensitivity 5 5
Ambulation Difficulties 5 5
Neck Pain 5 5
Impaired Healing 5 5
Abdominal Pain 5 5
Fever 5 5
Incontinence 5 5
Perforation 4 4
Pneumonia 4 4
Sepsis 4 4
Cardiac Arrest 4 4
Urinary Tract Infection 4 4
Depression 4 4
Tingling 4 4
Paraplegia 4 4
Disc Impingement 4 4
Joint Laxity 4 4
Rupture 3 3
Disability 3 3
Joint Disorder 3 3
Reaction 3 3
Pulmonary Embolism 3 3
Abscess 3 3
Anemia 3 3
Urinary Retention 3 3
Itching Sensation 3 3
Muscle Spasm(s) 3 3
Muscle Weakness 3 3
Intervertebral Disc Compression or Protrusion 3 3
Implant Pain 3 3
Loss of Range of Motion 2 2
Rash 2 2
Thrombosis 2 2
Paresis 2 2
Undesired Nerve Stimulation 2 2
Arthritis 2 2
Bruise/Contusion 2 2
Low Blood Pressure/ Hypotension 2 2
Hemostasis 2 2
Fatigue 2 2
Encephalopathy 2 2
Hernia 2 2
Burning Sensation 2 2
Malunion of Bone 2 2

Recalls
Manufacturer Recall Class Date Posted
1 CTL Medical Corporation II Jul-04-2020
2 DePuy Orthopaedics, Inc. II Mar-02-2018
3 DePuy Spine, Inc. II Apr-27-2019
4 Globus Medical, Inc. II Aug-22-2020
5 Howmedica Osteonics Corp. II Dec-13-2018
6 Integrity Implants Inc. II Nov-07-2018
7 Interventional Spine Inc II Jan-03-2017
8 K2M, Inc II Jun-01-2021
9 Kiscomedica S.A. II Feb-27-2017
10 Medicrea International II Feb-12-2020
11 Medtronic Sofamor Danek USA, Inc II Apr-20-2021
12 Neuropro Spinal Jaxx II Apr-10-2018
13 SPINEART SA III Nov-22-2019
14 Spinal Elements II May-23-2018
15 Stryker Spine II Apr-20-2021
16 Stryker Spine II Oct-10-2018
17 XTANT MEDICAL INC II Jan-30-2019
18 Zimmer Biomet Spine, Inc II Mar-28-2017
19 Zimmer Trabecular Metal Technology, Inc. III May-10-2017
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