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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device posterior cervical screw system
Definition Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to stabilize the spine in the absence of fusion for a limited time period in patients with tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
Product CodeNKG
Regulation Number 888.3075
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP IMPLANT SYSTEMS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
DOUBLE MEDICAL TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
K&J CONSULTING CORP.
  SUBSTANTIALLY EQUIVALENT 1
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 1
L & K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 4
MEDICREA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 5
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 3
OSSEUS FUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SIGNUS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SILONY MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SPINAL SIMPLICITY LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINEART
  SUBSTANTIALLY EQUIVALENT 2
ULRICH MEDICAL USA
  SUBSTANTIALLY EQUIVALENT 1
VY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 3
ZAVATION MEDICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 214 214
2020 236 236
2021 697 702
2022 175 178
2023 131 131
2024 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 638 638
Fracture 207 215
Migration 203 203
Break 142 142
Detachment of Device or Device Component 41 41
Material Integrity Problem 37 37
Insufficient Information 33 33
Device-Device Incompatibility 33 33
Material Separation 29 29
Patient Device Interaction Problem 26 26
Mechanical Problem 25 25
Material Twisted/Bent 24 24
Device Dislodged or Dislocated 23 23
No Apparent Adverse Event 14 14
Migration or Expulsion of Device 14 14
Loosening of Implant Not Related to Bone-Ingrowth 14 14
Material Deformation 11 11
Device Slipped 11 11
Appropriate Term/Code Not Available 10 10
Unintended Movement 9 9
Mechanical Jam 8 8
Difficult to Advance 8 8
Loose or Intermittent Connection 8 8
Compatibility Problem 8 8
Material Fragmentation 7 7
Malposition of Device 6 6
Disconnection 5 5
Separation Problem 5 5
Noise, Audible 5 5
Improper or Incorrect Procedure or Method 5 5
Contamination 5 5
Material Split, Cut or Torn 5 5
Entrapment of Device 4 4
Positioning Problem 3 3
Device Handling Problem 3 3
Activation, Positioning or Separation Problem 3 3
Structural Problem 3 3
Device Difficult to Maintain 2 2
Loss of Osseointegration 2 2
Physical Resistance/Sticking 2 2
Biocompatibility 2 2
Ambient Noise Problem 2 2
Difficult to Insert 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Scratched Material 1 1
Mechanics Altered 1 1
Nonstandard Device 1 1
Difficult to Open or Remove Packaging Material 1 1
Inadequacy of Device Shape and/or Size 1 1
Expulsion 1 1
Separation Failure 1 1
Incomplete or Missing Packaging 1 1
Material Puncture/Hole 1 1
Failure to Eject 1 1
Unintended Ejection 1 1
Defective Component 1 1
Missing Information 1 1
Difficult to Remove 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 325 333
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 140 140
No Code Available 130 130
Pain 123 123
Post Operative Wound Infection 115 115
No Consequences Or Impact To Patient 111 111
Failure of Implant 92 92
Injury 84 84
Spinal Cord Injury 66 66
Stenosis 52 52
Insufficient Information 46 46
Hypersensitivity/Allergic reaction 46 46
Unspecified Infection 43 43
Intervertebral Disc Compression or Protrusion 35 35
No Known Impact Or Consequence To Patient 32 32
Impaired Healing 30 30
Bone Fracture(s) 30 30
Non-union Bone Fracture 30 30
Unspecified Tissue Injury 20 20
No Patient Involvement 19 19
Neck Pain 19 19
Osteolysis 15 15
Loss of Range of Motion 12 12
Foreign Body In Patient 11 11
Vertebral Fracture 10 10
Discomfort 9 9
Nerve Damage 8 8
Device Embedded In Tissue or Plaque 8 8
Multiple Fractures 8 8
Muscle Weakness 8 8
Hematoma 7 7
Neurological Deficit/Dysfunction 6 6
Neuralgia 6 6
No Information 5 5
Ambulation Difficulties 5 5
Perforation of Vessels 5 5
Drug Resistant Bacterial Infection 5 5
Cerebrospinal Fluid Leakage 4 4
Bacterial Infection 4 4
Fall 4 4
Speech Disorder 3 3
Wound Dehiscence 3 3
Paralysis 3 3
Paraplegia 3 3
Headache 3 3
Implant Pain 3 3
Movement Disorder 2 2
Tissue Damage 2 2
Incontinence 2 2
Dysphagia/ Odynophagia 2 2
Rupture 2 2
Numbness 2 2
Physical Asymmetry 2 2
Neuropathy 2 2
Hypoesthesia 2 2
Skin Tears 1 1
Limited Mobility Of The Implanted Joint 1 1
Joint Laxity 1 1
Hemorrhage/Bleeding 1 1
Bruise/Contusion 1 1
Seroma 1 1
Oversedation 1 1
Fever 1 1
Solid Tumour 1 1
Post Traumatic Wound Infection 1 1
Pocket Erosion 1 1
Reaction 1 1
Respiratory Distress 1 1
Ulcer 1 1
Not Applicable 1 1
Inflammation 1 1
Paresis 1 1
Thrombosis/Thrombus 1 1
Pulmonary Embolism 1 1

Recalls
Manufacturer Recall Class Date Posted
1 K2M, Inc II Jan-27-2021
2 K2M, Inc II Dec-02-2020
3 K2M, Inc II Oct-09-2019
4 Synthes (USA) Products LLC II Oct-28-2019
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