TPLC - Total Product Life Cycle

• Device: thoracolumbosacral pedicle screw system
• Definition: Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
• Product Code: NKB
• Regulation Number: 888.3070
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AESCULAP IMPLANT SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	2
ALPHATEC SPINE, INC
	SUBSTANTIALLY EQUIVALENT	1
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	7
ALTUS PARTNERS, LLC
	SUBSTANTIALLY EQUIVALENT	5
ASTURA MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
AUXEIN MEDICAL PRIVATE LIMITED/71164
	SUBSTANTIALLY EQUIVALENT	1
AXIS ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
BACK 2 BASICS DIRECT, LLC
	SUBSTANTIALLY EQUIVALENT	2
BAUI BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BENVENUE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIEDERMANN MOTECH GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	2
BK MEDITECH CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BK MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BK MEDITECH, CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BLACK BOX MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
BLACK BOX MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
CALVARY SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
CAMBER SPINE TECHNOLOGIES LLC
	SUBSTANTIALLY EQUIVALENT	1
CAPTIVA SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
CARBOFIX ORTHOPEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	6
CHIRAL SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
CHOICE SPINE
	SUBSTANTIALLY EQUIVALENT	1
CHOICE SPINE, LP
	SUBSTANTIALLY EQUIVALENT	2
CLARIANCE SAS
	SUBSTANTIALLY EQUIVALENT	1
CLEARVIEW ORTHOPEDIC DEVELOPMENT, LLC
	SUBSTANTIALLY EQUIVALENT	1
COLIGNE AG
	SUBSTANTIALLY EQUIVALENT	1
CORELINK, LLC
	SUBSTANTIALLY EQUIVALENT	2
CORENTEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CTL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CURITEVA, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEGEN MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
EVOLUTION SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
G SURGICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
GBS COMMONWEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
GENESYS SPINE
	SUBSTANTIALLY EQUIVALENT	2
GETSET SURGICAL, SA
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	3
GLOBUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
GM DOS REIS INDUSTRIA E COMERICO LTDA
	SUBSTANTIALLY EQUIVALENT	1
GPC MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
GRAFTON MEDICAL ALLIANCE
	SUBSTANTIALLY EQUIVALENT	1
GS MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUVEXEL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ICOTEC AG
	SUBSTANTIALLY EQUIVALENT	2
IMPLANET S.A.
	SUBSTANTIALLY EQUIVALENT	1
IMPLANET, S.A.
	SUBSTANTIALLY EQUIVALENT	1
INDIUS MEDICAL TECHNOLOGIES PVT. LTD.
	SUBSTANTIALLY EQUIVALENT	1
INGENIUM SPINE
	SUBSTANTIALLY EQUIVALENT	1
INNOVATIVE SURGICAL DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	7
INTEGRITY IMPLANTS INC.
	SUBSTANTIALLY EQUIVALENT	1
INTEGRITY IMPLANTS, INC
	SUBSTANTIALLY EQUIVALENT	1
INTELIVATION LLC
	SUBSTANTIALLY EQUIVALENT	1
INTELLIGENT IMPLANT SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU TRAUHUI MEDICAL INSTRUMENT CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
JMT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JOIMAX GMBH
	SUBSTANTIALLY EQUIVALENT	1
K2M
	SUBSTANTIALLY EQUIVALENT	1
K2M INC.
	SUBSTANTIALLY EQUIVALENT	2
K2M, INC.
	SUBSTANTIALLY EQUIVALENT	3
KALITEC DIRECT, LLC
	SUBSTANTIALLY EQUIVALENT	1
L&K BIOMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	7
LIFE SPINE INC.
	SUBSTANTIALLY EQUIVALENT	3
LIFE SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	4
LINKSPINE INC
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	5
MEDICREA INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA INTERNATIONAL S.A
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	2
MEDICREA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	2
MEDOS INTERNATIONAL SÀRL
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL, SARL
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC
	SUBSTANTIALLY EQUIVALENT	3
MEDTRONIC SOFAMOR DANEK
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	6
MEDYNUS INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDYSSEY USA, INC.
	SUBSTANTIALLY EQUIVALENT	4
MET ONE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
MIRUS, LLC
	SUBSTANTIALLY EQUIVALENT	4
NANOVIS LLC
	SUBSTANTIALLY EQUIVALENT	1
NANOVIS SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
NEO MEDICAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
NEXT ORTHOSURGICAL
	SUBSTANTIALLY EQUIVALENT	1
NEXXT SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	4
NVISION BIOMEDICAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
ORBBO SURGICAL, LLC.
	SUBSTANTIALLY EQUIVALENT	1
ORION BIOTECH INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHO DEVELOPMENT CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
ORTHOCIRCLE SPINE
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX INC.
	SUBSTANTIALLY EQUIVALENT	2
ORTHOPEDIATRICS, CORP
	SUBSTANTIALLY EQUIVALENT	2
OSSEUS FUSION SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
OSTEOCENTRIC TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
PAONAN BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
PHAMEDICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY, INC. (DBA RTI SURGICAL, INC.)
	SUBSTANTIALLY EQUIVALENT	1
PRECISION SPINE
	SUBSTANTIALLY EQUIVALENT	1
PRECISION SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
PREMIA SPINE LTD.
	SUBSTANTIALLY EQUIVALENT	2
PRESIDIO SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
RELIANCE MEDICAL SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
REPUBLIC SPINE, L.L.C.
	SUBSTANTIALLY EQUIVALENT	1
REPUBLIC SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
RIVARP MEDICAL PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
S. M. A. I. O
	SUBSTANTIALLY EQUIVALENT	1
S.M.A.I.O
	SUBSTANTIALLY EQUIVALENT	1
S.M.A.I.O.
	SUBSTANTIALLY EQUIVALENT	1
SAFE ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	2
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	10
SEOHANCARE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGDONG KANGSHENG MEDICAL DEVICES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI REACH MEDICAL INSTRUMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
SHANGHAI SANYOU MEDICAL CO, LTD
	SUBSTANTIALLY EQUIVALENT	1
SIGNATURE ORTHOPAEDICS PTY LTD.
	SUBSTANTIALLY EQUIVALENT	1
SILONY MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
SOLCO BIOMEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ANALYTICS & GEOMETRICAL IMPLANT CO, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ELEMENTS INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ELEMENTS, INC
	SUBSTANTIALLY EQUIVALENT	1
SPINAL RESOURCES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINE SMITH HOLDINGS, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINE WAVE, INC.
	SUBSTANTIALLY EQUIVALENT	5
SPINEART
	SUBSTANTIALLY EQUIVALENT	5
SPINECRAFT, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINEOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	6
SPINEWAY SA
	SUBSTANTIALLY EQUIVALENT	1
SPINEWELDING AG
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
STRYKER SPINE
	SUBSTANTIALLY EQUIVALENT	1
SURGALIGN SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
SURGTECH INC.
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES USA PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	1
TDM CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
U&I CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
ULRICH MEDICAL USA
	SUBSTANTIALLY EQUIVALENT	1
VALORUS SPINE
	SUBSTANTIALLY EQUIVALENT	1
VY SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
WILTROM CORPORATION LIMITED
	SUBSTANTIALLY EQUIVALENT	2
X-SPINE SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
XENCO MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
ZAVATION MEDICAL PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	2
ZAVATION MEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER BIOMET SPINE, INC
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER BIOMET SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	4

MDR Year	MDR Reports	MDR Events
2017	1615	1615
2018	1681	1681
2019	1915	1915
2020	2066	2066
2021	1749	1751
2022	958	958

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1929	1929
Adverse Event Without Identified Device or Use Problem	1501	1501
Fracture	1093	1093
Migration	890	891
Material Deformation	877	877
Loose or Intermittent Connection	523	523
Detachment of Device or Device Component	371	371
Loosening of Implant Not Related to Bone-Ingrowth	357	357
Migration or Expulsion of Device	339	339
Device Slipped	315	315
Unintended Movement	240	240
Material Twisted/Bent	226	226
Device Dislodged or Dislocated	223	224
Device-Device Incompatibility	210	210
Device Operates Differently Than Expected	206	206
Mechanical Problem	161	161
Appropriate Term/Code Not Available	122	122
Material Separation	117	117
Material Split, Cut or Torn	101	101
Material Fragmentation	90	90
Insufficient Information	83	83
Material Integrity Problem	81	81
Disassembly	80	80
Malposition of Device	60	60
Torn Material	60	60
No Apparent Adverse Event	54	54
Patient Device Interaction Problem	51	51
Mechanical Jam	47	47
Biocompatibility	44	44
Detachment Of Device Component	44	44
Crack	43	43
Failure to Align	43	43
Difficult to Remove	38	38
Calibration Problem	34	34
Compatibility Problem	31	31
Use of Device Problem	30	30
Patient-Device Incompatibility	30	30
Disconnection	27	27
Mechanics Altered	27	27
Entrapment of Device	25	25
Noise, Audible	22	22
Separation Problem	22	22
Naturally Worn	21	21
Positioning Problem	20	20
Bent	19	19
Improper or Incorrect Procedure or Method	18	18
Corroded	17	17
Premature Separation	17	17
Device Markings/Labelling Problem	16	16
Difficult to Insert	14	14
Device Damaged by Another Device	12	12
Metal Shedding Debris	11	11
Failure to Osseointegrate	11	11
Unstable	11	11
Inadequacy of Device Shape and/or Size	9	9
Physical Resistance/Sticking	9	9
Expulsion	8	8
Separation Failure	8	8
Osseointegration Problem	7	7
Failure to Disconnect	6	6
Connection Problem	6	6
Device Handling Problem	6	6
Scratched Material	6	6
Peeled/Delaminated	6	6
Misassembled	6	6
Unintended System Motion	5	5
Failure To Adhere Or Bond	5	5
Product Quality Problem	5	5
Unstable Capture Threshold	5	5
Contamination /Decontamination Problem	5	5
Difficult to Advance	5	5
Material Protrusion/Extrusion	5	5
Packaging Problem	5	5
Installation-Related Problem	5	5
Device Operational Issue	4	4
Misassembled During Installation	4	4
Fitting Problem	4	4
Positioning Failure	4	4
Nonstandard Device	4	4
Leak/Splash	3	3
Therapeutic or Diagnostic Output Failure	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Protective Measures Problem	2	2
Output Problem	2	2
Device Contaminated During Manufacture or Shipping	2	2
Deformation Due to Compressive Stress	2	2
Flaked	2	2
Material Frayed	2	2
Component Incompatible	2	2
Material Disintegration	2	2
Structural Problem	2	2
Solder Joint Fracture	2	2
Device Issue	2	2
Device Appears to Trigger Rejection	2	2
Difficult To Position	2	2
Off-Label Use	2	2
Material Rupture	2	2
Suction Problem	1	1
Sticking	1	1
Unexpected Therapeutic Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	1890	1890
No Code Available	1706	1706
No Clinical Signs, Symptoms or Conditions	1574	1576
Pain	1114	1114
Failure of Implant	1103	1104
Injury	798	798
No Consequences Or Impact To Patient	688	688
Unspecified Infection	457	457
No Information	273	273
No Patient Involvement	273	273
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	270	270
Spinal Column Injury	245	245
Insufficient Information	198	198
Not Applicable	196	196
Non-union Bone Fracture	144	144
Foreign Body In Patient	128	128
Bone Fracture(s)	103	103
Device Embedded In Tissue or Plaque	95	95
Nerve Damage	82	82
Hypersensitivity/Allergic reaction	76	76
Post Operative Wound Infection	63	63
Patient Problem/Medical Problem	59	59
Neurological Deficit/Dysfunction	54	54
Osteolysis	49	49
Spinal Cord Injury	43	43
Fall	41	41
Hematoma	39	39
Death	38	38
Paralysis	38	38
Numbness	38	38
Inadequate Osseointegration	37	37
Tissue Damage	34	34
Discomfort	33	33
Stenosis	29	29
Itching Sensation	29	29
Unspecified Tissue Injury	29	29
Limited Mobility Of The Implanted Joint	27	27
Neuropathy	20	20
Reaction	19	19
Blood Loss	17	17
Swelling	16	16
Ambulation Difficulties	15	15
Impaired Healing	14	14
Rash	14	14
Vertebral Fracture	14	14
Dysphagia/ Odynophagia	13	13
Hemorrhage/Bleeding	13	13
Cardiac Arrest	12	12
Intraoperative Pain	12	12
Physical Asymmetry	12	12
Fever	11	11
Weakness	10	10
Paraplegia	9	9
Ulcer	9	9
Dizziness	9	9
Pressure Sores	8	8
Hypoesthesia	8	8
Paresis	8	8
Intervertebral Disc Compression or Protrusion	8	8
Inflammation	7	7
Muscle Weakness	7	7
Local Reaction	7	7
Purulent Discharge	7	7
Abscess	7	7
Malunion of Bone	7	7
Neck Pain	6	6
Tingling	6	6
Dyspnea	6	6
Loss of Range of Motion	6	6
Thrombosis	6	6
Implant Pain	6	6
Fatigue	5	5
Arthritis	5	5
Wound Dehiscence	5	5
Cerebrospinal Fluid Leakage	5	5
Disability	5	5
Unspecified Musculoskeletal problem	5	5
Paresthesia	5	5
Sudden Cardiac Death	4	4
Skin Tears	4	4
Joint Disorder	4	4
Respiratory Failure	4	4
Calcium Deposits/Calcification	4	4
Foreign Body Reaction	4	4
Pocket Erosion	4	4
Internal Organ Perforation	4	4
Swelling/ Edema	4	4
Myocardial Infarction	3	3
Autoimmune Reaction	3	3
Bacterial Infection	3	3
Collapse	3	3
Sedation	3	3
Perforation of Vessels	3	3
Rupture	3	3
Hernia	3	3
Depression	3	3
Unspecified Vascular Problem	3	3
Constipation	3	3
Convulsion/Seizure	3	3
Cancer	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Implant Systems LLC	II	Aug-26-2022
2	Aesculap Implant Systems LLC	II	Jul-21-2022
3	Alphatec Spine, Inc.	II	Jun-06-2017
4	Amendia, Inc	II	Jan-10-2018
5	Back 2 Basics Direct LLC	II	Aug-21-2018
6	CTL Medical Corporation	II	Mar-20-2019
7	Clariance Inc	III	Jul-18-2019
8	Howmedica Osteonics Corp.	II	Aug-05-2019
9	Innovasis, Inc	II	Feb-20-2018
10	Medicrea International	II	Mar-02-2020
11	Medicrea International	II	Dec-30-2019
12	Medtronic Sofamor Danek USA Inc	II	Aug-03-2018
13	OrthoPediatrics Corp	II	Jul-30-2020
14	Orthofix, Inc	II	Aug-18-2017
15	SAFE ORTHOPAEDICS LLC	II	Aug-24-2022
16	SPINEART SA	II	Jun-28-2021
17	U&I CORP.	II	Jul-20-2020
18	Zimmer Biomet Spine Inc.	II	Feb-22-2019
19	Zimmer Biomet, Inc.	II	Dec-15-2020
20	Zimmer Biomet, Inc.	II	Jun-02-2020