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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
Regulation Description Intervertebral body fusion device.
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
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 2
CHOICESPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
CLARIANCE
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE, SA
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 2
DIO MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
EDISONINNO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EMINENT SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
EVOLUTION SPINE
  SUBSTANTIALLY EQUIVALENT 1
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 3
GS MEDICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
INNOSYS 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
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NANOHIVE MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
NEUROSTRUCTURES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRO SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAGICO VA USA, LLC
  SUBSTANTIALLY EQUIVALENT 2
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
SIGNUS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN MEDICAL (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ANALYTICS & GEOMETRICAL IMPLANT CO, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
SPINEUP INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION SAS
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION, S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
U&I CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
XENCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 162 162
2021 192 192
2022 200 200
2023 150 150
2024 144 144
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 129 129
Fracture 119 119
Break 118 118
Material Integrity Problem 105 105
Migration 53 53
Mechanical Problem 49 49
Patient Device Interaction Problem 40 40
Compatibility Problem 40 40
Difficult to Insert 36 36
Detachment of Device or Device Component 26 26
Material Twisted/Bent 23 23
Insufficient Information 21 21
Physical Resistance/Sticking 18 18
Crack 18 18
Failure to Osseointegrate 14 14
Material Fragmentation 12 12
Improper or Incorrect Procedure or Method 11 11
Device-Device Incompatibility 11 11
Manufacturing, Packaging or Shipping Problem 9 9
Material Separation 8 8
Activation, Positioning or Separation Problem 8 8
Material Deformation 8 8
Loss of Osseointegration 8 8
Use of Device Problem 7 7
Malposition of Device 6 6
Device Dislodged or Dislocated 6 6
Positioning Problem 6 6
Mechanical Jam 5 5
No Apparent Adverse Event 5 5
Unintended Movement 4 4
Migration or Expulsion of Device 4 4
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Difficult to Remove 4 4
Entrapment of Device 3 3
Patient-Device Incompatibility 3 3
Misassembly by Users 3 3
Labelling, Instructions for Use or Training Problem 2 2
Device Fell 2 2
Premature Separation 2 2
Separation Failure 2 2
Component Missing 2 2
Osseointegration Problem 2 2
Loose or Intermittent Connection 2 2
Expulsion 1 1
Failure to Cut 1 1
Corroded 1 1
Component Misassembled 1 1
Inaccurate Information 1 1
Naturally Worn 1 1
Unintended Collision 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 418 418
No Consequences Or Impact To Patient 89 89
Insufficient Information 65 65
No Known Impact Or Consequence To Patient 52 52
Failure of Implant 51 51
Pain 42 42
Dysphagia/ Odynophagia 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Osteolysis 21 21
Bone Fracture(s) 17 17
Neck Pain 17 17
Non-union Bone Fracture 16 16
Malunion of Bone 12 12
Foreign Body In Patient 12 12
Nerve Damage 11 11
No Code Available 11 11
Hematoma 10 10
Physical Asymmetry 9 9
Ossification 9 9
Unspecified Tissue Injury 8 8
Post Operative Wound Infection 8 8
Paralysis 7 7
Cerebrospinal Fluid Leakage 7 7
Injury 6 6
Metal Related Pathology 5 5
Airway Obstruction 5 5
Spinal Cord Injury 5 5
Dysphasia 5 5
Subluxation 4 4
Swelling/ Edema 4 4
Inadequate Osseointegration 3 3
Unspecified Musculoskeletal problem 3 3
Quadriplegia 2 2
Numbness 2 2
Patient Problem/Medical Problem 2 2
Device Embedded In Tissue or Plaque 2 2
Speech Disorder 2 2
Thrombosis/Thrombus 2 2
Discomfort 2 2
Hemorrhage/Bleeding 2 2
Unspecified Infection 2 2
Loss of Range of Motion 2 2
Paraplegia 1 1
Osteopenia/ Osteoporosis 1 1
Decreased Sensitivity 1 1
Perforation of Esophagus 1 1
No Information 1 1
Sore Throat 1 1
Unspecified Nervous System Problem 1 1
Hematemesis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 K2M, Inc II Oct-13-2021
2 Medtronic Sofamor Danek USA Inc II Oct-12-2021
3 Stryker Spine II Sep-23-2024
4 U&I CORP. II Apr-29-2020
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