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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
ACUITY SURGICAL DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ADCURA, INC.
  SUBSTANTIALLY EQUIVALENT 1
AEGIS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC SPINE
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 10
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
AMPLIFY SURGICAL INC
  SUBSTANTIALLY EQUIVALENT 1
AMPLIFY SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 3
BAAT MEDICAL PRODUCTS BV
  SUBSTANTIALLY EQUIVALENT 1
BAUI BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BENVENUE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOGEND THERAPEUTICS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
CAMBER SPINE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARLSMED, INC.
  SUBSTANTIALLY EQUIVALENT 5
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
  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 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
CTL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
CUTTING EDGE SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 3
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
DIFUSION TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
EIT EMERGING IMPLANT TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 2
EMINENT SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
ENZTEC LIMITED
  SUBSTANTIALLY EQUIVALENT 4
EXPANDING INNOVATIONS, INC
  SUBSTANTIALLY EQUIVALENT 3
EXPANDING INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
FIMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FLOSPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
GBS COMMONWEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 4
GS MEDICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 3
INTEGRITY IMPLANTS INC
  SUBSTANTIALLY EQUIVALENT 3
INTEGRITY IMPLANTS INC.
  SUBSTANTIALLY EQUIVALENT 4
INTELIVATION LLC
  SUBSTANTIALLY EQUIVALENT 1
JOIMAX GMBH
  SUBSTANTIALLY EQUIVALENT 1
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 1
KALITEC MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
KEOS
  SUBSTANTIALLY EQUIVALENT 1
KUROS BIOSCIENCES BV
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 7
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 7
MEDACTA INERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S .A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 4
MEDOS INTERNATIONAL SÀRL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 5
MEDTRONIC SOFAMOR DANEK, USA INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
MET ONE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
MET ONE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 3
NANOHIVE MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
NEO MEDICAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
NEUROSTRUCTURES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 4
NGMEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 10
NVISION BIOMEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
OC MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX US LLC
  SUBSTANTIALLY EQUIVALENT 1
PANTHEON SPINAL
  SUBSTANTIALLY EQUIVALENT 2
PAONAN BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PARADIGM SPINE, GMBH
  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
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 LLC
  SUBSTANTIALLY EQUIVALENT 1
REPUBLIC SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 2
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 14
SHANGHAI REACH MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI SANYOU MEDICAL CO, LTD
  SUBSTANTIALLY EQUIVALENT 2
SIGNUS MEDIZINTECHNIK
  SUBSTANTIALLY EQUIVALENT 1
SILONY MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SOLCO BIOMEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN MEDICAL (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
SPINAL ELEMENTS
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
SPINAL STABILITY, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEEX INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINEVISION SAS
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION, S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
SPINEWORXX AG
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 1
TDM CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TRANS1
  SUBSTANTIALLY EQUIVALENT 1
U&I CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
WENZEL SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
XENCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 3
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 4
ZS FAB INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 699 699
2020 640 640
2021 621 621
2022 618 623
2023 578 578
2024 311 311

Device Problems MDRs with this Device Problem Events in those MDRs
Break 853 853
Migration 511 511
Adverse Event Without Identified Device or Use Problem 467 467
Device-Device Incompatibility 297 297
Fracture 268 272
Compatibility Problem 134 134
Mechanical Problem 116 116
Material Integrity Problem 106 106
Insufficient Information 92 92
Material Deformation 81 82
Migration or Expulsion of Device 80 80
Mechanical Jam 60 60
Collapse 57 57
Detachment of Device or Device Component 56 56
Appropriate Term/Code Not Available 55 55
Mechanics Altered 50 50
Patient Device Interaction Problem 48 48
Material Twisted/Bent 39 39
Use of Device Problem 39 39
Device Dislodged or Dislocated 35 35
Material Fragmentation 35 35
No Apparent Adverse Event 26 26
Malposition of Device 24 24
Physical Resistance/Sticking 23 23
Crack 21 21
Improper or Incorrect Procedure or Method 20 20
Loosening of Implant Not Related to Bone-Ingrowth 20 20
Difficult to Insert 17 18
Device Handling Problem 14 14
Unintended Movement 14 14
Entrapment of Device 12 12
Device Slipped 11 11
Device Sensing Problem 11 11
Material Separation 10 10
Positioning Problem 10 10
Difficult to Advance 8 8
Expulsion 8 8
Device Damaged by Another Device 7 7
Inadequacy of Device Shape and/or Size 7 7
Difficult to Remove 6 6
Difficult or Delayed Positioning 6 6
Imprecision 6 6
Failure to Eject 6 6
Inaccurate Information 6 6
Material Split, Cut or Torn 5 5
Osseointegration Problem 5 5
Product Quality Problem 5 5
Loose or Intermittent Connection 5 5
Biocompatibility 5 5
Contamination /Decontamination Problem 4 4
Unstable 4 4
Human-Device Interface Problem 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Unintended System Motion 3 3
Off-Label Use 3 3
Naturally Worn 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Markings/Labelling Problem 3 3
Patient-Device Incompatibility 3 3
Failure to Osseointegrate 3 3
Output Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Device Difficult to Maintain 3 3
Activation Failure 2 2
Separation Problem 2 2
Failure to Advance 2 2
Failure to Disconnect 2 2
Separation Failure 2 2
Activation, Positioning or Separation Problem 2 2
Installation-Related Problem 2 2
Difficult to Open or Close 2 2
Device Damaged Prior to Use 2 2
Defective Component 2 2
Microbial Contamination of Device 2 2
Solder Joint Fracture 2 2
Misassembled 2 2
Material Erosion 2 2
Positioning Failure 1 1
Disconnection 1 1
Degraded 1 1
Use of Incorrect Control/Treatment Settings 1 1
Nonstandard Device 1 1
Labelling, Instructions for Use or Training Problem 1 1
Dull, Blunt 1 1
Loss of Osseointegration 1 1
Unexpected Therapeutic Results 1 1
Partial Blockage 1 1
Device Appears to Trigger Rejection 1 1
Inadequate User Interface 1 1
Material Protrusion/Extrusion 1 1
Connection Problem 1 1
Deformation Due to Compressive Stress 1 1
Defective Device 1 1
Device Tipped Over 1 1
Premature Separation 1 1
Activation Problem 1 1
Ejection Problem 1 1
Misassembly by Users 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1343 1348
No Known Impact Or Consequence To Patient 430 430
Pain 322 322
No Consequences Or Impact To Patient 230 230
Insufficient Information 227 227
No Code Available 210 210
Failure of Implant 132 132
Unspecified Infection 103 103
Device Embedded In Tissue or Plaque 83 83
Foreign Body In Patient 80 80
Nerve Damage 67 67
Non-union Bone Fracture 62 62
Unspecified Tissue Injury 60 60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 59 59
Hematoma 54 54
Osteolysis 51 51
Injury 47 47
Post Operative Wound Infection 42 42
Joint Laxity 36 36
Bone Fracture(s) 34 34
No Patient Involvement 30 30
Neuropathy 25 25
No Information 24 24
Cerebrospinal Fluid Leakage 22 22
Hemorrhage/Bleeding 21 21
Laceration(s) 18 18
Perforation of Vessels 18 18
Unspecified Nervous System Problem 18 18
Spinal Cord Injury 17 17
Numbness 15 15
Tissue Damage 15 15
Stenosis 14 14
Vertebral Fracture 13 13
Unspecified Musculoskeletal problem 13 13
Weakness 13 13
Patient Problem/Medical Problem 12 12
Hypersensitivity/Allergic reaction 11 11
Fall 11 11
Arthritis 11 11
Wound Dehiscence 10 10
Dysphagia/ Odynophagia 10 10
Spinal Column Injury 10 10
Impaired Healing 10 10
Discomfort 9 9
Inadequate Osseointegration 9 9
Paralysis 9 9
Headache 8 8
Cyst(s) 8 8
Neck Pain 7 7
Excessive Tear Production 7 7
Decreased Sensitivity 7 7
Intervertebral Disc Compression or Protrusion 7 7
Implant Pain 6 6
Hypoesthesia 6 6
Damage to Ligament(s) 6 6
Sepsis 6 6
Seroma 5 5
Swelling 5 5
Inflammation 5 5
Muscle Weakness 5 5
Neurological Deficit/Dysfunction 5 5
Cardiac Arrest 5 5
Pulmonary Embolism 5 5
Abscess 5 5
Aspiration/Inhalation 5 5
Incontinence 5 5
Blood Loss 5 5
Speech Disorder 5 5
Ambulation Difficulties 4 4
Thrombosis/Thrombus 4 4
Depression 4 4
Urinary Tract Infection 4 4
Hernia 4 4
Pneumonia 4 4
Undesired Nerve Stimulation 4 4
Itching Sensation 3 3
Muscle Spasm(s) 3 3
Perforation 3 3
Loss of Range of Motion 3 3
Rash 3 3
Fever 3 3
Bacterial Infection 3 3
Rupture 3 3
Tingling 3 3
Osteopenia/ Osteoporosis 3 3
Thromboembolism 3 3
Bowel Perforation 3 3
Paresthesia 3 3
Nervous System Injury 3 3
Swelling/ Edema 3 3
Movement Disorder 2 2
Unspecified Vascular Problem 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Urinary Incontinence 2 2
Malunion of Bone 2 2
Disc Impingement 2 2
Joint Disorder 2 2
Anemia 2 2
Abdominal Pain 2 2
Bruise/Contusion 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Research Medical, LLC II Apr-29-2024
2 CTL Medical Corporation II Jul-04-2020
3 CoreLink LLC II Jan-12-2023
4 DePuy Spine, Inc. II Jul-01-2022
5 DePuy Spine, Inc. II Apr-27-2019
6 Globus Medical, Inc. II Aug-22-2020
7 K2M, Inc II Jun-01-2021
8 Medicrea International II Aug-24-2023
9 Medicrea International II Feb-12-2020
10 Medtronic Sofamor Danek USA, Inc II Apr-20-2021
11 SPINEART SA III Nov-22-2019
12 Stryker Spine II Apr-20-2021
13 XTANT MEDICAL INC II Jan-30-2019
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