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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
  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
MIRUS, LLC
  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 205 205
2025 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 658 658
Migration 245 245
Fracture 243 251
Break 169 169
Detachment of Device or Device Component 61 61
Insufficient Information 58 58
Device-Device Incompatibility 39 39
Material Integrity Problem 37 37
Material Separation 31 31
Device Dislodged or Dislocated 26 26
Material Twisted/Bent 26 26
Mechanical Problem 26 26
Patient Device Interaction Problem 26 26
Device Slipped 18 18
Loosening of Implant Not Related to Bone-Ingrowth 17 17
No Apparent Adverse Event 14 14
Migration or Expulsion of Device 14 14
Appropriate Term/Code Not Available 12 12
Compatibility Problem 12 12
Material Deformation 12 12
Mechanical Jam 10 10
Entrapment of Device 9 9
Unintended Movement 9 9
Difficult to Advance 9 9
Loose or Intermittent Connection 8 8
Material Fragmentation 7 7
Separation Problem 7 7
Malposition of Device 6 6
Material Erosion 6 6
Contamination 5 5
Material Split, Cut or Torn 5 5
Improper or Incorrect Procedure or Method 5 5
Disconnection 5 5
Noise, Audible 5 5
Device Handling Problem 3 3
Positioning Problem 3 3
Structural Problem 3 3
Biocompatibility 3 3
Activation, Positioning or Separation Problem 3 3
Physical Resistance/Sticking 2 2
Ambient Noise Problem 2 2
Loss of Osseointegration 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Difficult to Insert 2 2
Device Difficult to Maintain 2 2
Expulsion 1 1
Use of Device Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Scratched Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 408 416
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 148 148
No Code Available 130 130
Pain 128 128
Post Operative Wound Infection 115 115
No Consequences Or Impact To Patient 111 111
Failure of Implant 105 105
Injury 84 84
Insufficient Information 84 84
Spinal Cord Injury 68 68
Stenosis 54 54
Unspecified Infection 50 50
Hypersensitivity/Allergic reaction 46 46
Non-union Bone Fracture 43 43
Intervertebral Disc Compression or Protrusion 35 35
No Known Impact Or Consequence To Patient 32 32
Bone Fracture(s) 32 32
Impaired Healing 31 31
Neck Pain 24 24
Unspecified Tissue Injury 21 21
No Patient Involvement 19 19
Nerve Damage 18 18
Foreign Body In Patient 16 16
Osteolysis 15 15
Vertebral Fracture 15 15
Loss of Range of Motion 14 14
Discomfort 9 9
Muscle Weakness 9 9
Device Embedded In Tissue or Plaque 8 8
Multiple Fractures 8 8
Hematoma 8 8
Fall 7 7
Spinal Column Injury 7 7
Dysphagia/ Odynophagia 7 7
Speech Disorder 6 6
Neuralgia 6 6
Metal Related Pathology 6 6
Bacterial Infection 6 6
Perforation of Vessels 6 6
Ambulation Difficulties 6 6
Neurological Deficit/Dysfunction 6 6
Wound Dehiscence 5 5
Cerebrospinal Fluid Leakage 5 5
Drug Resistant Bacterial Infection 5 5
Inflammation 5 5
No Information 5 5
Numbness 5 5
Physical Asymmetry 4 4
Unspecified Mental, Emotional or Behavioural Problem 4 4
Headache 4 4

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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