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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 110 110

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 694 694
Break 251 251
Fracture 229 237
Migration 227 227
Detachment of Device or Device Component 66 66
Device-Device Incompatibility 42 42
Torn Material 42 42
Unintended Movement 42 42
Material Integrity Problem 38 38
Device Dislodged or Dislocated 37 37
Insufficient Information 37 37
Material Separation 33 33
Mechanical Problem 27 27
Material Twisted/Bent 27 27
Migration or Expulsion of Device 26 26
Patient Device Interaction Problem 26 26
Loose or Intermittent Connection 21 21
Device Slipped 20 20
Loosening of Implant Not Related to Bone-Ingrowth 17 17
No Apparent Adverse Event 14 14
Material Deformation 14 14
Material Fragmentation 14 14
Mechanical Jam 12 12
Compatibility Problem 12 12
Appropriate Term/Code Not Available 11 11
Difficult to Advance 9 9
Detachment Of Device Component 9 9
Noise, Audible 8 8
Disconnection 7 7
Device Operates Differently Than Expected 7 7
Malposition of Device 7 7
Separation Problem 6 6
Material Split, Cut or Torn 6 6
Contamination 5 5
Improper or Incorrect Procedure or Method 5 5
Entrapment of Device 5 5
Manufacturing, Packaging or Shipping Problem 3 3
Positioning Problem 3 3
Physical Resistance/Sticking 3 3
Activation, Positioning or Separation Problem 3 3
Structural Problem 3 3
Device Handling Problem 3 3
Biocompatibility 2 2
Loss of Osseointegration 2 2
Difficult to Insert 2 2
Device Difficult to Maintain 2 2
Inadequacy of Device Shape and/or Size 2 2
Ambient Noise Problem 2 2
Component Falling 1 1
Device Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 364 372
No Code Available 196 196
Pain 162 162
Failure of Implant 154 154
No Consequences Or Impact To Patient 147 147
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 144 144
No Known Impact Or Consequence To Patient 118 118
Post Operative Wound Infection 115 115
Injury 90 90
Spinal Cord Injury 67 67
Insufficient Information 61 61
Unspecified Infection 59 59
Stenosis 52 52
Hypersensitivity/Allergic reaction 46 46
Non-union Bone Fracture 45 45
Impaired Healing 43 43
Intervertebral Disc Compression or Protrusion 35 35
Bone Fracture(s) 32 32
Neck Pain 24 24
No Patient Involvement 22 22
Fatigue 21 21
Unspecified Tissue Injury 20 20
No Information 19 19
Not Applicable 18 18
Device Embedded In Tissue or Plaque 18 18
Osteolysis 15 15
Headache 14 14
Foreign Body In Patient 14 14
Vertebral Fracture 13 13
Loss of Range of Motion 13 13
Neuropathy 12 12
Spinal Column Injury 11 11
Dizziness 10 10
Positive antinuclear antibodies (ANA) 10 10
Rash 10 10
Chills 10 10
Foreign Body Sensation in Eye 10 10
Nerve Damage 9 9
Discomfort 9 9
Hematoma 8 8
Muscle Weakness 8 8
Multiple Fractures 8 8
Fall 8 8
Neurological Deficit/Dysfunction 7 7
Neuralgia 6 6
Ambulation Difficulties 6 6
Inflammation 5 5
Drug Resistant Bacterial Infection 5 5
Perforation of Vessels 5 5
Wound Dehiscence 5 5

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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