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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
AESCULAP IMPLANT SYSTEMS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BIOMET SPINE
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CENTINEL SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SYNTHES, INC.
  SUBSTANTIALLY EQUIVALENT 1
DOUBLE MEDICAL TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
G SURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
K&J CONSULTING CORP.
  SUBSTANTIALLY EQUIVALENT 1
K2M
  SUBSTANTIALLY EQUIVALENT 1
K2M INC.
  SUBSTANTIALLY EQUIVALENT 1
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 2
K2M, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
L & K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
L&K BIOMED CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 3
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 5
MEDICREA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2
MEDICREA INTERNATIONAL S.A
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 6
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 6
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 6
ORTHOFIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSSEUS FUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC. (DBA RTI SURGICAL, INC.)
  SUBSTANTIALLY EQUIVALENT 2
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
PROVIDENCE MEDICAL TECHNOLOGY, INC.
  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 ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL SIMPLICITY LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPINEART
  SUBSTANTIALLY EQUIVALENT 3
SPINECRAFT LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES USA PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
U & I CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
U&I CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ULRICH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
ULRICH MEDICAL USA
  SUBSTANTIALLY EQUIVALENT 1
VY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 3
X-SPINE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
XENCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER SPINE, INC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2015 4 4
2016 73 73
2017 99 99
2018 127 127
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 684 684
Break 244 244
Fracture 221 229
Migration 208 208
Detachment of Device or Device Component 52 52
Torn Material 42 42
Unintended Movement 42 42
Material Integrity Problem 38 38
Device-Device Incompatibility 37 37
Device Dislodged or Dislocated 36 36
Insufficient Information 35 35
Material Separation 33 33
Mechanical Problem 26 26
Migration or Expulsion of Device 26 26
Patient Device Interaction Problem 26 26
Material Twisted/Bent 25 25
Loose or Intermittent Connection 21 21
Device Slipped 18 18
Material Fragmentation 14 14
No Apparent Adverse Event 14 14
Loosening of Implant Not Related to Bone-Ingrowth 14 14
Material Deformation 13 13
Appropriate Term/Code Not Available 11 11
Mechanical Jam 10 10
Detachment Of Device Component 9 9
Difficult to Advance 8 8
Compatibility Problem 8 8
Noise, Audible 8 8
Device Operates Differently Than Expected 7 7
Malposition of Device 7 7
Disconnection 7 7
Material Split, Cut or Torn 6 6
Separation Problem 6 6
Entrapment of Device 5 5
Contamination 5 5
Improper or Incorrect Procedure or Method 5 5
Structural Problem 3 3
Physical Resistance/Sticking 3 3
Device Handling Problem 3 3
Positioning Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Activation, Positioning or Separation Problem 3 3
Device Difficult to Maintain 2 2
Loss of Osseointegration 2 2
Ambient Noise Problem 2 2
Biocompatibility 2 2
Difficult to Insert 2 2
Unintended Ejection 1 1
Crack 1 1
Component Falling 1 1
Defective Component 1 1
Incomplete or Missing Packaging 1 1
Device Issue 1 1
Nonstandard Device 1 1
Material Puncture/Hole 1 1
Difficult to Remove 1 1
Difficult to Open or Remove Packaging Material 1 1
Expulsion 1 1
Inadequacy of Device Shape and/or Size 1 1
Separation Failure 1 1
Patient-Device Incompatibility 1 1
Scratched Material 1 1
Mechanics Altered 1 1
Missing Information 1 1
Failure to Eject 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 325 333
No Code Available 196 196
Pain 161 161
No Consequences Or Impact To Patient 147 147
Failure of Implant 145 145
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 140 140
No Known Impact Or Consequence To Patient 118 118
Post Operative Wound Infection 115 115
Injury 90 90
Spinal Cord Injury 66 66
Unspecified Infection 53 53
Stenosis 52 52
Hypersensitivity/Allergic reaction 46 46
Insufficient Information 46 46
Impaired Healing 43 43
Non-union Bone Fracture 41 41
Intervertebral Disc Compression or Protrusion 35 35
Bone Fracture(s) 32 32
No Patient Involvement 22 22
Neck Pain 21 21
Fatigue 20 20
Unspecified Tissue Injury 20 20
No Information 19 19
Device Embedded In Tissue or Plaque 18 18
Not Applicable 18 18
Osteolysis 15 15
Foreign Body In Patient 14 14
Headache 13 13
Neuropathy 12 12
Loss of Range of Motion 12 12
Spinal Column Injury 11 11
Chills 10 10
Dizziness 10 10
Rash 10 10
Positive antinuclear antibodies (ANA) 10 10
Foreign Body Sensation in Eye 10 10
Vertebral Fracture 10 10
Discomfort 9 9
Hematoma 8 8
Muscle Weakness 8 8
Nerve Damage 8 8
Multiple Fractures 8 8
Neurological Deficit/Dysfunction 7 7
Fall 7 7
Neuralgia 6 6
Drug Resistant Bacterial Infection 5 5
Perforation of Vessels 5 5
Ambulation Difficulties 5 5
Numbness 4 4
Cerebrospinal Fluid Leakage 4 4
Wound Dehiscence 4 4
Bacterial Infection 4 4
Paralysis 3 3
Paraplegia 3 3
Speech Disorder 3 3
Implant Pain 3 3
Physical Asymmetry 2 2
Movement Disorder 2 2
Hypoesthesia 2 2
Tissue Damage 2 2
Rupture 2 2
Dysphagia/ Odynophagia 2 2
Incontinence 2 2
Hemorrhage/Bleeding 1 1
Fever 1 1
Bruise/Contusion 1 1
Pulmonary Embolism 1 1
Paresis 1 1
Pocket Erosion 1 1
Inflammation 1 1
Oversedation 1 1
Respiratory Distress 1 1
Seroma 1 1
Ulcer 1 1
Sedation 1 1
Reaction 1 1
Intraoperative Pain 1 1
Limited Mobility Of The Implanted Joint 1 1
Low Oxygen Saturation 1 1
Skin Tears 1 1
Post Traumatic Wound Infection 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 Orthofix, Inc II Apr-11-2018
5 Synthes (USA) Products LLC II Oct-28-2019
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