TPLC - Total Product Life Cycle

• Device: thoracolumbosacral pedicle screw system
• Regulation Description: 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	3
ALPHATEC SPINE, INC
	SUBSTANTIALLY EQUIVALENT	2
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	5
ALTUS PARTNERS, LLC
	SUBSTANTIALLY EQUIVALENT	4
AMEDICA CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
AMENDIA, INC.
	SUBSTANTIALLY EQUIVALENT	3
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	1
CHOICE SPINE, LP
	SUBSTANTIALLY EQUIVALENT	2
CLARIANCE SAS
	SUBSTANTIALLY EQUIVALENT	2
CLARIANCE, SAS
	SUBSTANTIALLY EQUIVALENT	1
CLEARVIEW ORTHOPEDIC DEVELOPMENT, LLC
	SUBSTANTIALLY EQUIVALENT	1
COLIGNE AG
	SUBSTANTIALLY EQUIVALENT	1
CORELINK, LLC
	SUBSTANTIALLY EQUIVALENT	1
CORENTEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CTL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CURITEVA, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEGEN MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
EVOLUTION SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
FACETLINK DBA LINKSPINE
	SUBSTANTIALLY EQUIVALENT	1
G SURGICAL LLC
	SUBSTANTIALLY EQUIVALENT	2
GBS COMMONWEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
GENESYS SPINE
	SUBSTANTIALLY EQUIVALENT	3
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	3
IMPLANET S.A.
	SUBSTANTIALLY EQUIVALENT	1
IMPLANET, S.A.
	SUBSTANTIALLY EQUIVALENT	2
INDIUS MEDICAL TECHNOLOGIES PVT. LTD.
	SUBSTANTIALLY EQUIVALENT	1
INGENIUM SPINE
	SUBSTANTIALLY EQUIVALENT	1
INNOVATIVE SURGICAL DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	5
INTEGRITY IMPLANTS INC.
	SUBSTANTIALLY EQUIVALENT	1
INTEGRITY IMPLANTS, INC
	SUBSTANTIALLY EQUIVALENT	1
INTELLIGENT IMPLANT SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	2
JIANGSU TRAUHUI MEDICAL INSTRUMENT CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
JOIMAX GMBH
	SUBSTANTIALLY EQUIVALENT	1
K2M
	SUBSTANTIALLY EQUIVALENT	1
K2M INC.
	SUBSTANTIALLY EQUIVALENT	2
K2M, INC.
	SUBSTANTIALLY EQUIVALENT	3
K2M, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
KALITEC DIRECT, LLC
	SUBSTANTIALLY EQUIVALENT	1
L&K BIOMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	8
LIFE SPINE INC.
	SUBSTANTIALLY EQUIVALENT	3
LIFE SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
LINKSPINE INC
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	5
MEDICREA INTERNATIONAL S.A
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	5
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	2
MEDOS INTERNATIONAL SÀRL
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL, SARL
	SUBSTANTIALLY EQUIVALENT	3
MEDTRONIC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA, INC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	10
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	2
NEXUS SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
NEXXT SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	6
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	3
ORTHOPEDIATRICS CORP.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPEDIATRICS, CORP
	SUBSTANTIALLY EQUIVALENT	2
OSSEUS FUSION SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
OSSO SURGICAL
	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
S.M.A.I.O
	SUBSTANTIALLY EQUIVALENT	1
SAFE ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	2
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	10
SENECKA SPINE
	SUBSTANTIALLY EQUIVALENT	1
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	1
SHANGHAI SANYOU MEDICAL CO, LTD
	SUBSTANTIALLY EQUIVALENT	1
SIGNATURE ORTHOPAEDICS PTY LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIGNUS MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
SILONY MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
SOLCO BIOMEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ANALYTICS & GEOMETRICAL IMPLANT CO, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINAL BALANCE, INC.
	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	4
SPINEART
	SUBSTANTIALLY EQUIVALENT	4
SPINECRAFT, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINEOLOGY INC
	SUBSTANTIALLY EQUIVALENT	1
SPINEOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	7
SPINEOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINEWAY S.A.
	SUBSTANTIALLY EQUIVALENT	1
SPINEWAY SA
	SUBSTANTIALLY EQUIVALENT	1
SPINEWELDING AG
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
STRYKER SPINE
	SUBSTANTIALLY EQUIVALENT	1
SURGTECH INC.
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES USA PRODUCTS LLC
	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
WILTROM CORPORATION LIMITED
	SUBSTANTIALLY EQUIVALENT	2
X-SPINE SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
XENCO MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
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
2016	1585	1585
2017	1615	1615
2018	1681	1681
2019	1915	1915
2020	2066	2066
2021	805	807

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1995	1995
Adverse Event Without Identified Device or Use Problem	1334	1334
Fracture	1058	1058
Material Deformation	730	730
Migration	668	669
Loose or Intermittent Connection	606	606
Migration or Expulsion of Device	442	442
Detachment of Device or Device Component	322	322
Device Slipped	274	274
Unintended Movement	268	268
Device Dislodged or Dislocated	252	253
Loosening of Implant Not Related to Bone-Ingrowth	248	248
Device Operates Differently Than Expected	224	224
Appropriate Term/Code Not Available	162	162
Torn Material	158	158
Mechanical Problem	152	152
Device-Device Incompatibility	152	152
Material Twisted/Bent	140	140
Material Separation	116	116
Disassembly	104	104
Material Split, Cut or Torn	100	100
Insufficient Information	95	95
Material Fragmentation	93	93
Failure to Align	86	86
Material Integrity Problem	76	76
Detachment Of Device Component	72	72
Malposition of Device	60	60
Difficult to Remove	56	56
No Apparent Adverse Event	49	49
Biocompatibility	44	44
Metal Shedding Debris	43	43
Patient Device Interaction Problem	41	41
Mechanical Jam	41	41
Crack	40	40
Use of Device Problem	34	34
Calibration Problem	34	34
Fitting Problem	33	33
Disconnection	27	27
Compatibility Problem	27	27
Device Damaged by Another Device	26	26
Bent	25	25
Positioning Problem	24	24
Difficult to Insert	24	24
Naturally Worn	22	22
Patient-Device Incompatibility	20	20
Device Markings/Labelling Problem	20	20
Corroded	18	18
Improper or Incorrect Procedure or Method	17	17
Noise, Audible	17	17
Device Inoperable	16	16
Failure To Adhere Or Bond	16	16
Entrapment of Device	15	15
Separation Problem	15	15
Failure to Osseointegrate	11	11
Premature Separation	11	11
Mechanics Altered	10	10
Unstable	10	10
Inadequacy of Device Shape and/or Size	9	9
Device Issue	8	8
Peeled/Delaminated	7	7
Connection Problem	6	6
Failure to Disconnect	6	6
Physical Resistance/Sticking	6	6
Separation Failure	6	6
Nonstandard Device	5	5
Material Protrusion/Extrusion	5	5
Device Handling Problem	5	5
Packaging Problem	5	5
Device Operational Issue	5	5
Unstable Capture Threshold	5	5
Osseointegration Problem	5	5
Product Quality Problem	5	5
Misassembled	5	5
Difficult to Advance	4	4
Dull, Blunt	4	4
Positioning Failure	4	4
Installation-Related Problem	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Scratched Material	3	3
Leak/Splash	3	3
Flaked	2	2
Misconnection	2	2
Unintended System Motion	2	2
Material Rupture	2	2
Solder Joint Fracture	2	2
Material Distortion	2	2
Device Contaminated During Manufacture or Shipping	2	2
Protective Measures Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Misassembled During Installation	2	2
Material Disintegration	2	2
Difficult To Position	2	2
Off-Label Use	2	2
Deformation Due to Compressive Stress	2	2
Structural Problem	2	2
Component Incompatible	2	2
Suction Problem	1	1
Microbial Contamination of Device	1	1
Component Missing	1	1
Expiration Date Error	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	2430	2430
No Code Available	2081	2081
Pain	1222	1222
Failure of Implant	1124	1125
Injury	1038	1038
No Consequences Or Impact To Patient	734	734
No Clinical Signs, Symptoms or Conditions	633	635
No Information	374	374
No Patient Involvement	278	278
Unspecified Infection	264	264
Spinal Column Injury	236	236
Not Applicable	200	200
Non-union Bone Fracture	150	150
Bone Fracture(s)	106	106
Foreign Body In Patient	102	102
Device Embedded In Tissue or Plaque	92	92
Insufficient Information	87	87
Nerve Damage	77	77
Hypersensitivity/Allergic reaction	75	75
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	71	71
Patient Problem/Medical Problem	62	62
Neurological Deficit/Dysfunction	58	58
Fall	54	54
Discomfort	51	51
Spinal Cord Injury	42	42
Death	41	41
Reaction	35	35
Inadequate Osseointegration	34	34
Paralysis	34	34
Tissue Damage	34	34
Numbness	34	34
Post Operative Wound Infection	29	29
Itching Sensation	28	28
Stenosis	27	27
Impaired Healing	27	27
Limited Mobility Of The Implanted Joint	27	27
Sedation	23	23
Neuropathy	23	23
Blood Loss	20	20
Hematoma	19	19
Unspecified Tissue Injury	18	18
Swelling	17	17
Ambulation Difficulties	15	15
Rash	14	14
Dysphagia/ Odynophagia	13	13
Intraoperative Pain	13	13
Cardiac Arrest	12	12
Irritation	12	12
Weakness	11	11
Vertebral Fracture	10	10
Fever	10	10
Osteolysis	10	10
Dizziness	9	9
Paraplegia	8	8
Pressure Sores	8	8
Hypoesthesia	8	8
Paresis	8	8
Tingling	7	7
Necrosis	7	7
Local Reaction	7	7
Hemorrhage/Bleeding	6	6
Disability	6	6
Dyspnea	6	6
Cerebrospinal Fluid Leakage	6	6
Ulcer	6	6
Thrombosis	6	6
Loss of Range of Motion	6	6
Sudden Cardiac Death	6	6
Collapse	6	6
Arthritis	5	5
Internal Organ Perforation	5	5
Foreign Body Reaction	4	4
Bacterial Infection	4	4
Joint Disorder	4	4
Radiation Exposure, Unintended	4	4
Wound Dehiscence	4	4
Abscess	4	4
Calcium Deposits/Calcification	4	4
Muscle Weakness	4	4
Respiratory Failure	4	4
Hernia	3	3
Inflammation	3	3
Muscle Spasm(s)	3	3
Autoimmune Reaction	3	3
Depression	3	3
Myocardial Infarction	3	3
Constipation	3	3
Swelling/ Edema	2	2
Damage to Ligament(s)	2	2
Abdominal Pain	2	2
Scar Tissue	2	2
Complaint, Ill-Defined	2	2
Infection, Pyrogenic	2	2
Skin Irritation	2	2
Rupture	2	2
Neck Pain	2	2
Cancer	2	2
Unspecified Vascular Problem	2	2
Intervertebral Disc Compression or Protrusion	2	2
Physical Asymmetry	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Alphatec Spine, Inc.	II	Jun-06-2017
2	Alphatec Spine, Inc.	II	Nov-16-2016
3	Amendia, Inc	II	Jan-10-2018
4	Back 2 Basics Direct LLC	II	Aug-21-2018
5	CTL Medical Corporation	II	Mar-20-2019
6	Clariance Inc	III	Jul-18-2019
7	Howmedica Osteonics Corp.	II	Aug-05-2019
8	Innovasis, Inc	II	Feb-20-2018
9	Innovasis, Inc	II	Jan-19-2016
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	OrthoPediatrics Corp	II	Jan-08-2016
15	Orthofix, Inc	II	Aug-18-2017
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
21	Zimmer Spine, Inc.	II	Mar-18-2016