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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, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE IMPLANTS, INC
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ATLAS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BESPOKE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
BLUSTONE SYNERGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CHOICESPINE, LLC
  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
EDISONINNO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELEVATION SPINE
  SUBSTANTIALLY EQUIVALENT 1
EMINENT SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 3
HUVEXEL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 2
MEDICREA INTERNATIONAL S. A.
  SUBSTANTIALLY EQUIVALENT 1
NANOHIVE MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
NEUROSTRUCTURES, INC.
  SUBSTANTIALLY EQUIVALENT 2
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEUP INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION SAS
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION, S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
TITAN SPINE, INC
  SUBSTANTIALLY EQUIVALENT 1
U&I CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 210 210
2019 169 169
2020 162 162
2021 192 192
2022 200 200

Device Problems MDRs with this Device Problem Events in those MDRs
Break 236 236
Adverse Event Without Identified Device or Use Problem 165 165
Fracture 97 97
Material Integrity Problem 56 56
Material Twisted/Bent 55 55
Difficult to Insert 43 43
Mechanical Problem 41 41
Migration 39 39
Detachment of Device or Device Component 38 38
Crack 34 34
Patient Device Interaction Problem 29 29
Insufficient Information 27 27
Compatibility Problem 21 21
Device-Device Incompatibility 18 18
Physical Resistance/Sticking 18 18
Bent 15 15
Positioning Problem 14 14
Unintended Movement 10 10
Failure to Osseointegrate 10 10
Material Fragmentation 9 9
Migration or Expulsion of Device 8 8
Mechanical Jam 8 8
Malposition of Device 8 8
Loss of Osseointegration 8 8
Appropriate Term/Code Not Available 8 8
Use of Device Problem 7 7
Material Deformation 6 6
No Apparent Adverse Event 5 5
Component Missing 5 5
Entrapment of Device 5 5
Loose or Intermittent Connection 4 4
Dull, Blunt 4 4
Difficult to Remove 4 4
Unstable 4 4
Activation, Positioning or Separation Problem 4 4
Difficult to Advance 4 4
Device Dislodged or Dislocated 4 4
Device Operates Differently Than Expected 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Misassembly by Users 3 3
Device Slipped 3 3
Defective Component 3 3
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Device Fell 3 3
Device Damaged Prior to Use 2 2
Material Separation 2 2
Partial Blockage 2 2
Complete Blockage 2 2
Detachment Of Device Component 2 2
Device Difficult to Maintain 2 2
Device Damaged by Another Device 2 2
Installation-Related Problem 2 2
Failure to Advance 2 2
Split 2 2
Failure to Cut 1 1
Failure to Align 1 1
Patient-Device Incompatibility 1 1
Deformation Due to Compressive Stress 1 1
Device Markings/Labelling Problem 1 1
Expulsion 1 1
Scratched Material 1 1
Packaging Problem 1 1
Material Protrusion/Extrusion 1 1
Mechanics Altered 1 1
Naturally Worn 1 1
Component Incompatible 1 1
Corroded 1 1
Difficult or Delayed Positioning 1 1
Positioning Failure 1 1
Incorrect Measurement 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Erosion 1 1
Flaked 1 1
Inadequacy of Device Shape and/or Size 1 1
Peeled/Delaminated 1 1
Material Puncture/Hole 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Solder Joint Fracture 1 1
Inappropriate Tactile Prompt/Feedback 1 1
Misassembled During Installation 1 1
Inaccurate Information 1 1
Noise, Audible 1 1
Component Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 229 229
No Known Impact Or Consequence To Patient 199 199
No Consequences Or Impact To Patient 189 189
No Code Available 87 87
Dysphagia/ Odynophagia 49 49
Failure of Implant 47 47
Pain 44 44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 32 32
Neck Pain 24 24
Bone Fracture(s) 23 23
Non-union Bone Fracture 13 13
No Information 13 13
Osteolysis 13 13
Foreign Body Sensation in Eye 12 12
Patient Problem/Medical Problem 11 11
Insufficient Information 11 11
Paralysis 11 11
Injury 10 10
Foreign Body In Patient 10 10
Hematoma 10 10
Ossification 9 9
Nerve Damage 9 9
No Patient Involvement 9 9
Physical Asymmetry 9 9
Swollen Glands 8 8
Malunion of Bone 8 8
Quadriplegia 7 7
Cerebrospinal Fluid Leakage 7 7
Unspecified Infection 7 7
Post Operative Wound Infection 7 7
Dysphasia 6 6
Unspecified Tissue Injury 6 6
Burning Sensation 5 5
Airway Obstruction 5 5
Swelling/ Edema 4 4
Subluxation 4 4
Loss of Range of Motion 4 4
Swollen Lymph Nodes 4 4
Swelling 3 3
Spinal Cord Injury 3 3
Not Applicable 3 3
Nausea 2 2
Speech Disorder 2 2
Thrombosis/Thrombus 2 2
Hypoesthesia 2 2
Neurological Deficit/Dysfunction 2 2
Erosion 2 2
Calcium Deposits/Calcification 2 2
Spinal Column Injury 2 2
Numbness 2 2
Dizziness 2 2
Headache 2 2
Inadequate Osseointegration 2 2
Device Embedded In Tissue or Plaque 2 2
Discomfort 2 2
Vertebral Fracture 1 1
Unspecified Musculoskeletal problem 1 1
Scarring 1 1
Weakness 1 1
Stenosis 1 1
Paraplegia 1 1
Blood Loss 1 1
Sore Throat 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Metal Related Pathology 1 1
Perforation of Vessels 1 1
Joint Dislocation 1 1
Fall 1 1
Tinnitus 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Amendia, Inc II Jan-04-2018
2 K2M, Inc II Oct-13-2021
3 Medtronic Sofamor Danek USA Inc II Oct-12-2021
4 SpineFrontier, Inc. II Jul-12-2019
5 U&I CORP. II Apr-29-2020
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