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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
ACUITY SURGICAL DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ADCURA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED RESEARCH MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
AEGIS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC SPINE
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 9
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 5
AMPLIFY SURGICAL INC
  SUBSTANTIALLY EQUIVALENT 1
AMPLIFY SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 3
CENTINEL SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHOICE SPINE, LP.
  SUBSTANTIALLY EQUIVALENT 1
CHOICESPINE LLC
  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 2
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 2
EXPANDING INNOVATIONS, INC
  SUBSTANTIALLY EQUIVALENT 3
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
GS MEDICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 2
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 5
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 5
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 19
NVISION BIOMEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
OC MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
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
RESTOR3D
  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 15
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
TDM CO., LTD
  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 5
ZAVATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
ZS FAB 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 532 537

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1177 1177
Adverse Event Without Identified Device or Use Problem 494 494
Migration 406 406
Fracture 281 285
Migration or Expulsion of Device 232 232
Device-Device Incompatibility 221 221
Material Integrity Problem 110 110
Mechanical Jam 93 93
Compatibility Problem 89 89
Material Deformation 80 81
Mechanical Problem 67 67
Collapse 64 64
Appropriate Term/Code Not Available 60 60
Insufficient Information 56 56
Device Dislodged or Dislocated 56 56
Detachment of Device or Device Component 56 56
Material Fragmentation 53 53
Device Operates Differently Than Expected 50 50
Malposition of Device 45 45
Unintended Movement 43 43
Crack 34 34
Material Twisted/Bent 32 32
Difficult to Insert 29 30
Mechanics Altered 28 28
Use of Device Problem 26 26
No Apparent Adverse Event 25 25
Physical Resistance/Sticking 24 24
Patient Device Interaction Problem 23 23
Improper or Incorrect Procedure or Method 21 21
Detachment Of Device Component 20 20
Loosening of Implant Not Related to Bone-Ingrowth 19 19
Loose or Intermittent Connection 17 17
Device Slipped 16 16
Positioning Problem 16 16
Device Handling Problem 15 15
Difficult to Remove 12 12
Fitting Problem 11 11
Patient-Device Incompatibility 10 10
Separation Failure 9 9
Inadequacy of Device Shape and/or Size 9 9
Material Separation 8 8
Material Disintegration 8 8
Material Protrusion/Extrusion 7 7
Device Damaged by Another Device 7 7
Device Sensing Problem 7 7
Expulsion 7 7
Difficult to Advance 7 7
Failure to Eject 6 6
Entrapment of Device 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
Inaccurate Information 5 5
Device Operational Issue 5 5
Device Markings/Labelling Problem 5 5
Activation, Positioning or Separation Problem 5 5
Installation-Related Problem 4 4
Human Factors Issue 4 4
Material Erosion 4 4
Off-Label Use 4 4
Imprecision 4 4
Sticking 4 4
Failure to Align 4 4
Failure to Advance 3 3
Defective Device 3 3
Contamination /Decontamination Problem 3 3
Defective Component 3 3
Product Quality Problem 3 3
Nonstandard Device 3 3
Component Falling 3 3
Connection Problem 3 3
Naturally Worn 3 3
Therapeutic or Diagnostic Output Failure 3 3
Output Problem 3 3
Device Difficult to Maintain 3 3
Missing Value Reason 2 2
Material Split, Cut or Torn 2 2
Device Fell 2 2
Separation Problem 2 2
Packaging Problem 2 2
Osseointegration Problem 2 2
Failure to Disconnect 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Degraded 2 2
Disconnection 2 2
Labelling, Instructions for Use or Training Problem 2 2
Device Damaged Prior to Use 2 2
Loss of Osseointegration 2 2
Component Missing 2 2
Solder Joint Fracture 2 2
Failure to Infuse 1 1
Split 1 1
Failure to Form Staple 1 1
Component or Accessory Incompatibility 1 1
Device Displays Incorrect Message 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 804 809
No Code Available 373 373
Pain 354 354
No Consequences Or Impact To Patient 346 346
Failure of Implant 172 172
Injury 120 120
Device Embedded In Tissue or Plaque 102 102
Insufficient Information 89 89
Unspecified Infection 84 84
No Information 83 83
Foreign Body In Patient 72 72
No Patient Involvement 70 70
Hematoma 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 41 41
Unspecified Tissue Injury 39 39
Nerve Damage 39 39
Bone Fracture(s) 37 37
Non-union Bone Fracture 33 33
Post Operative Wound Infection 31 31
Cerebrospinal Fluid Leakage 24 24
Neuropathy 24 24
Numbness 23 23
Patient Problem/Medical Problem 22 22
Osteolysis 22 22
Hemorrhage/Bleeding 19 19
Tissue Damage 18 18
Weakness 17 17
Neurological Deficit/Dysfunction 16 16
Spinal Column Injury 15 15
Blood Loss 15 15
Not Applicable 14 14
Stenosis 13 13
Perforation of Vessels 13 13
Damage to Ligament(s) 13 13
Fall 12 12
Vertebral Fracture 11 11
Unspecified Nervous System Problem 10 10
Wound Dehiscence 10 10
Laceration(s) 9 9
Paralysis 9 9
Discomfort 9 9
Excessive Tear Production 8 8
Spinal Cord Injury 8 8
Inadequate Osseointegration 8 8
Headache 8 8
Dysphagia/ Odynophagia 8 8
Death 8 8
Hypersensitivity/Allergic reaction 8 8
Cyst(s) 7 7
Inflammation 7 7
Swelling 7 7
Sepsis 7 7
Aspiration/Inhalation 6 6
Inadequate Pain Relief 6 6
Hypoesthesia 6 6
Impaired Healing 5 5
Neck Pain 5 5
Ambulation Difficulties 5 5
Bowel Perforation 5 5
Decreased Sensitivity 5 5
Abdominal Pain 5 5
Cardiac Arrest 5 5
Fever 5 5
Incontinence 5 5
Perforation 4 4
Pneumonia 4 4
Disc Impingement 4 4
Unspecified Musculoskeletal problem 4 4
Intervertebral Disc Compression or Protrusion 4 4
Joint Laxity 4 4
Paraplegia 4 4
Depression 4 4
Urinary Tract Infection 4 4
Tingling 4 4
Rupture 3 3
Reaction 3 3
Disability 3 3
Joint Disorder 3 3
Itching Sensation 3 3
Muscle Spasm(s) 3 3
Muscle Weakness 3 3
Urinary Retention 3 3
Pulmonary Embolism 3 3
Abscess 3 3
Anemia 3 3
Implant Pain 3 3
Arthritis 2 2
Bruise/Contusion 2 2
Low Blood Pressure/ Hypotension 2 2
Hemostasis 2 2
Encephalopathy 2 2
Fatigue 2 2
Thrombosis 2 2
Burning Sensation 2 2
Loss of Range of Motion 2 2
Rash 2 2
Paresis 2 2
Undesired Nerve Stimulation 2 2
Hernia 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 Jul-01-2022
4 DePuy Spine, Inc. II Apr-27-2019
5 Globus Medical, Inc. II Aug-22-2020
6 Howmedica Osteonics Corp. II Dec-13-2018
7 Integrity Implants Inc. II Nov-07-2018
8 Interventional Spine Inc II Jan-03-2017
9 K2M, Inc II Jun-01-2021
10 Kiscomedica S.A. II Feb-27-2017
11 Medicrea International II Feb-12-2020
12 Medtronic Sofamor Danek USA, Inc II Apr-20-2021
13 Neuropro Spinal Jaxx II Apr-10-2018
14 SPINEART SA III Nov-22-2019
15 Spinal Elements II May-23-2018
16 Stryker Spine II Apr-20-2021
17 Stryker Spine II Oct-10-2018
18 XTANT MEDICAL INC II Jan-30-2019
19 Zimmer Biomet Spine, Inc II Mar-28-2017
20 Zimmer Trabecular Metal Technology, Inc. III May-10-2017
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