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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
Regulation Description 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, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CG MEDTECH CO., 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
HIGHRIDGE MEDICAL, LLC
  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 2
MEDICREA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
MET ONE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 2
OSSEUS FUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
SIGNUS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SILONY MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SPINAL SIMPLICITY LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINEART
  SUBSTANTIALLY EQUIVALENT 1
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
2020 236 236
2021 704 709
2022 175 178
2023 131 131
2024 206 206
2025 125 125

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 608 608
Fracture 254 262
Migration 234 234
Break 132 132
Insufficient Information 57 57
Detachment of Device or Device Component 53 53
Device-Device Incompatibility 39 39
Material Integrity Problem 36 36
Material Separation 31 31
Mechanical Problem 27 27
Patient Device Interaction Problem 27 27
Material Twisted/Bent 25 25
Device Dislodged or Dislocated 24 24
Loosening of Implant Not Related to Bone-Ingrowth 18 18
Compatibility Problem 14 14
Mechanical Jam 13 13
Material Deformation 13 13
Device Slipped 12 12
Entrapment of Device 9 9
Separation Problem 8 8
No Apparent Adverse Event 8 8
Appropriate Term/Code Not Available 7 7
Loose or Intermittent Connection 6 6
Migration or Expulsion of Device 6 6
Material Erosion 6 6
Unintended Movement 6 6
Noise, Audible 5 5
Difficult to Insert 5 5
Contamination 5 5
Malposition of Device 5 5
Device Markings/Labelling Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Material Fragmentation 3 3
Positioning Problem 3 3
Structural Problem 3 3
Device Handling Problem 3 3
Difficult to Advance 3 3
Activation, Positioning or Separation Problem 3 3
Biocompatibility 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Ambient Noise Problem 2 2
Patient-Device Incompatibility 2 2
Osseointegration Problem 2 2
Loss of Osseointegration 2 2
Disconnection 2 2
Scratched Material 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Positioning Failure 1 1
Unintended Ejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 470 478
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 151 151
Pain 121 121
Post Operative Wound Infection 119 119
Insufficient Information 105 105
Failure of Implant 102 102
No Consequences Or Impact To Patient 75 75
Spinal Cord Injury 71 71
Stenosis 56 56
Unspecified Infection 41 41
Non-union Bone Fracture 40 40
No Code Available 39 39
Injury 38 38
Intervertebral Disc Compression or Protrusion 35 35
Bone Fracture(s) 31 31
Impaired Healing 29 29
Neck Pain 29 29
Unspecified Tissue Injury 29 29
Hypersensitivity/Allergic reaction 24 24
Nerve Damage 21 21
Osteolysis 16 16
Foreign Body In Patient 15 15
Vertebral Fracture 15 15
Loss of Range of Motion 13 13
Spinal Column Injury 12 12
Hematoma 12 12
Dysphagia/ Odynophagia 11 11
Muscle Weakness 10 10
Fall 9 9
No Patient Involvement 9 9
Multiple Fractures 8 8
No Known Impact Or Consequence To Patient 8 8
Bacterial Infection 7 7
Speech Disorder 7 7
Cerebrospinal Fluid Leakage 6 6
Perforation of Vessels 6 6
Metal Related Pathology 6 6
Neuralgia 6 6
Ambulation Difficulties 6 6
Device Embedded In Tissue or Plaque 6 6
Discomfort 6 6
Inflammation 5 5
Headache 5 5
Drug Resistant Bacterial Infection 5 5
Wound Dehiscence 5 5
Physical Asymmetry 4 4
Paralysis 4 4
Pulmonary Embolism 4 4
Unspecified Mental, Emotional or Behavioural Problem 4 4
Numbness 4 4

Recalls
Manufacturer Recall Class Date Posted
1 K2M, Inc II Jan-27-2021
2 K2M, Inc II Dec-02-2020
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