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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 Code	NKG
Regulation Number	888.3075
Device Class	2

Premarket Reviews
Manufacturer	Decision
AESCULAP IMPLANT SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ALTUS PARTNERS, LLC
	SUBSTANTIALLY EQUIVALENT	1
CARBOFIX ORTHOPEDICS , LTD.
	SUBSTANTIALLY EQUIVALENT	2
CG MEDTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DOUBLE MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
HIGHRIDGE MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
ICOTEC AG
	SUBSTANTIALLY EQUIVALENT	1
K&J CONSULTING CORP.
	SUBSTANTIALLY EQUIVALENT	1
L&K BIOMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	3
MET ONE TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
MIRUS, LLC
	SUBSTANTIALLY EQUIVALENT	1
NU VASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	2
ORTHOFIX, INC.
	SUBSTANTIALLY EQUIVALENT	1
OSSEUS FUSION SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
SEASPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIGNATURE ORTHOPAEDICS PTY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIGNUS MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
SPINAL SIMPLICITY, LLC
	SUBSTANTIALLY EQUIVALENT	1
ULRICH MEDICAL USA
	SUBSTANTIALLY EQUIVALENT	1
VY SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	3
ZAVATION MEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG DECANS MEDICAL DEVICES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	577	577
Fracture	237	246
Migration	195	197
Break	101	101
Insufficient Information	60	60
Detachment of Device or Device Component	50	51
Material Integrity Problem	31	32
Material Twisted/Bent	31	33
Device-Device Incompatibility	26	28
Patient Device Interaction Problem	24	24
Mechanical Problem	22	22
Compatibility Problem	17	17
Device Dislodged or Dislocated	16	16
Material Separation	16	16
Material Deformation	15	15
Loosening of Implant Not Related to Bone-Ingrowth	12	12
Device Slipped	10	10
Mechanical Jam	10	10
Entrapment of Device	10	10
Separation Problem	8	8
Material Erosion	6	6
Noise, Audible	5	5
Migration or Expulsion of Device	5	7
Malposition of Device	5	5
Appropriate Term/Code Not Available	5	5
Contamination	5	5
Difficult to Insert	5	5
Loose or Intermittent Connection	4	4
Device Markings/Labelling Problem	4	4
Unintended Movement	4	4
Positioning Problem	4	4
Biocompatibility	3	3
Improper or Incorrect Procedure or Method	3	3
Structural Problem	3	3
Material Fragmentation	3	3
Difficult to Advance	3	3
Activation, Positioning or Separation Problem	3	4
Material Rupture	2	2
Ambient Noise Problem	2	2
No Apparent Adverse Event	2	2
Patient-Device Incompatibility	2	2
Osseointegration Problem	2	2
Loss of Osseointegration	2	2
Disconnection	2	2
Unintended Ejection	1	1
Positioning Failure	1	1
Use of Device Problem	1	2
Device Misassembled During Manufacturing /Shipping	1	1
Inadequacy of Device Shape and/or Size	1	1
Scratched Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	474	489
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	156	156
Insufficient Information	144	144
Post Operative Wound Infection	119	119
Pain	115	115
Failure of Implant	73	73
Spinal Cord Injury	71	72
Stenosis	56	56
Non-union Bone Fracture	41	41
Intervertebral Disc Compression or Protrusion	35	35
Bone Fracture(s)	34	34
Impaired Healing	29	29
Unspecified Tissue Injury	29	29
Neck Pain	29	29
Unspecified Infection	25	25
Nerve Damage	21	21
Osteolysis	17	17
Vertebral Fracture	15	15
Hematoma	13	13
Foreign Body In Patient	12	13
Spinal Column Injury	12	12
Dysphagia/ Odynophagia	10	10
Loss of Range of Motion	10	10
Muscle Weakness	10	10
Fall	8	10
Multiple Fractures	8	8
Cerebrospinal Fluid Leakage	7	7
Bacterial Infection	7	7
Speech Disorder	7	7
Neuralgia	6	6
Ambulation Difficulties	6	6
Metal Related Pathology	6	6
Hypersensitivity/Allergic reaction	6	6
Perforation of Vessels	6	6
Inflammation	5	5
Wound Dehiscence	5	5
Discomfort	5	5
Headache	5	5
Drug Resistant Bacterial Infection	5	5
Physical Asymmetry	4	4
Pulmonary Embolism	4	4
Unspecified Mental, Emotional or Behavioural Problem	4	4
Device Embedded In Tissue or Plaque	4	4
Implant Pain	3	3
Movement Disorder	3	3
Paralysis	3	3
Thrombosis/Thrombus	3	3
Hemorrhage/Bleeding	3	3
Numbness	3	3
Laceration(s)	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	K2M, Inc	II	Jan-27-2021