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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 53 53

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 642 642
Migration 211 211
Fracture 208 216
Break 145 145
Detachment of Device or Device Component 42 42
Material Integrity Problem 37 37
Insufficient Information 33 33
Device-Device Incompatibility 33 33
Material Separation 29 29
Patient Device Interaction Problem 26 26
Material Twisted/Bent 25 25
Mechanical Problem 25 25
Device Dislodged or Dislocated 23 23
Migration or Expulsion of Device 14 14
Loosening of Implant Not Related to Bone-Ingrowth 14 14
No Apparent Adverse Event 14 14
Device Slipped 13 13
Material Deformation 11 11
Appropriate Term/Code Not Available 10 10
Unintended Movement 9 9
Mechanical Jam 9 9
Compatibility Problem 9 9
Difficult to Advance 8 8
Loose or Intermittent Connection 8 8
Material Fragmentation 7 7
Malposition of Device 6 6
Improper or Incorrect Procedure or Method 5 5
Contamination 5 5
Disconnection 5 5
Noise, Audible 5 5
Material Split, Cut or Torn 5 5
Separation Problem 5 5
Entrapment of Device 4 4
Structural Problem 3 3
Device Handling Problem 3 3
Activation, Positioning or Separation Problem 3 3
Positioning Problem 3 3
Device Difficult to Maintain 2 2
Physical Resistance/Sticking 2 2
Loss of Osseointegration 2 2
Ambient Noise Problem 2 2
Biocompatibility 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Difficult to Insert 2 2
Inadequacy of Device Shape and/or Size 1 1
Defective Component 1 1
Incomplete or Missing Packaging 1 1
Unintended Ejection 1 1
Positioning Failure 1 1
Nonstandard Device 1 1
Material Puncture/Hole 1 1
Difficult to Remove 1 1
Expulsion 1 1
Difficult to Open or Remove Packaging Material 1 1
Patient-Device Incompatibility 1 1
Separation Failure 1 1
Missing Information 1 1
Failure to Eject 1 1
Scratched Material 1 1
Mechanics Altered 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 334 342
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
Insufficient Information 54 54
Stenosis 52 52
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
Non-union Bone Fracture 31 31
Impaired Healing 30 30
Bone Fracture(s) 30 30
Neck Pain 21 21
Unspecified Tissue Injury 20 20
No Patient Involvement 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
Multiple Fractures 8 8
Device Embedded In Tissue or Plaque 8 8
Muscle Weakness 8 8
Nerve Damage 8 8
Hematoma 7 7
Neurological Deficit/Dysfunction 6 6
Neuralgia 6 6
No Information 5 5
Perforation of Vessels 5 5
Ambulation Difficulties 5 5
Drug Resistant Bacterial Infection 5 5
Bacterial Infection 4 4
Cerebrospinal Fluid Leakage 4 4
Fall 4 4
Wound Dehiscence 3 3
Headache 3 3
Paralysis 3 3
Paraplegia 3 3
Speech Disorder 3 3
Implant Pain 3 3
Physical Asymmetry 2 2
Movement Disorder 2 2
Numbness 2 2
Hypoesthesia 2 2
Neuropathy 2 2
Tissue Damage 2 2
Rupture 2 2
Incontinence 2 2
Dysphagia/ Odynophagia 2 2
Fever 1 1
Pulmonary Embolism 1 1
Bruise/Contusion 1 1
Inflammation 1 1
Hemorrhage/Bleeding 1 1
Ulcer 1 1
Respiratory Distress 1 1
Seroma 1 1
Oversedation 1 1
Paresis 1 1
Pocket Erosion 1 1
Reaction 1 1
Skin Tears 1 1
Post Traumatic Wound Infection 1 1
Not Applicable 1 1
Limited Mobility Of The Implanted Joint 1 1
Joint Laxity 1 1
Solid Tumour 1 1
Thrombosis/Thrombus 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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