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	2
ALPHATEC SPINE, INC
	SUBSTANTIALLY EQUIVALENT	1
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	6
ALTUS PARTNERS, LLC
	SUBSTANTIALLY EQUIVALENT	4
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	1
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	5
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
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	2
LINKSPINE INC
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	5
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	1
MEDOS INTERNATIONAL SÀRL
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL, SARL
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC
	SUBSTANTIALLY EQUIVALENT	2
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
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
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
S.M.A.I.O
	SUBSTANTIALLY EQUIVALENT	1
SAFE ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	2
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	9
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
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 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	6
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	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	1746	1748

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1810	1810
Adverse Event Without Identified Device or Use Problem	1215	1215
Fracture	980	980
Material Deformation	825	825
Migration	803	804
Loose or Intermittent Connection	521	521
Detachment of Device or Device Component	339	339
Migration or Expulsion of Device	328	328
Loosening of Implant Not Related to Bone-Ingrowth	288	288
Device Slipped	280	280
Unintended Movement	238	238
Device Operates Differently Than Expected	206	206
Device Dislodged or Dislocated	196	197
Device-Device Incompatibility	177	177
Material Twisted/Bent	177	177
Mechanical Problem	147	147
Appropriate Term/Code Not Available	119	119
Material Separation	110	110
Material Split, Cut or Torn	101	101
Disassembly	80	80
Material Fragmentation	74	74
Material Integrity Problem	73	73
Insufficient Information	72	72
Torn Material	60	60
No Apparent Adverse Event	49	49
Malposition of Device	48	48
Patient Device Interaction Problem	46	46
Mechanical Jam	44	44
Biocompatibility	44	44
Detachment Of Device Component	44	44
Failure to Align	43	43
Crack	40	40
Difficult to Remove	37	37
Calibration Problem	34	34
Compatibility Problem	30	30
Use of Device Problem	29	29
Disconnection	27	27
Entrapment of Device	22	22
Noise, Audible	22	22
Naturally Worn	21	21
Positioning Problem	20	20
Separation Problem	20	20
Patient-Device Incompatibility	20	20
Bent	19	19
Corroded	17	17
Improper or Incorrect Procedure or Method	16	16
Device Markings/Labelling Problem	15	15
Mechanics Altered	14	14
Difficult to Insert	13	13
Device Damaged by Another Device	12	12
Premature Separation	11	11
Metal Shedding Debris	11	11
Failure to Osseointegrate	11	11
Unstable	11	11
Inadequacy of Device Shape and/or Size	9	9
Separation Failure	8	8
Physical Resistance/Sticking	7	7
Connection Problem	6	6
Peeled/Delaminated	6	6
Product Quality Problem	5	5
Misassembled	5	5
Unintended System Motion	5	5
Failure To Adhere Or Bond	5	5
Failure to Disconnect	5	5
Material Protrusion/Extrusion	5	5
Installation-Related Problem	5	5
Osseointegration Problem	5	5
Device Handling Problem	5	5
Unstable Capture Threshold	5	5
Packaging Problem	5	5
Misassembled During Installation	4	4
Scratched Material	4	4
Device Operational Issue	4	4
Difficult to Advance	4	4
Expulsion	4	4
Contamination /Decontamination Problem	4	4
Nonstandard Device	4	4
Fitting Problem	4	4
Positioning Failure	3	3
Leak/Splash	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Therapeutic or Diagnostic Output Failure	2	2
Protective Measures 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
Device Inoperable	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	1172	1174
Failure of Implant	1053	1054
Pain	1015	1015
Injury	798	798
No Consequences Or Impact To Patient	688	688
No Patient Involvement	273	273
No Information	273	273
Unspecified Infection	254	254
Spinal Column Injury	237	237
Not Applicable	196	196
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	183	183
Insufficient Information	142	142
Non-union Bone Fracture	133	133
Foreign Body In Patient	106	106
Bone Fracture(s)	97	97
Device Embedded In Tissue or Plaque	88	88
Nerve Damage	77	77
Hypersensitivity/Allergic reaction	75	75
Patient Problem/Medical Problem	59	59
Neurological Deficit/Dysfunction	54	54
Post Operative Wound Infection	48	48
Spinal Cord Injury	43	43
Fall	39	39
Death	38	38
Osteolysis	38	38
Numbness	36	36
Inadequate Osseointegration	35	35
Paralysis	35	35
Tissue Damage	34	34
Hematoma	32	32
Discomfort	32	32
Itching Sensation	28	28
Stenosis	27	27
Limited Mobility Of The Implanted Joint	27	27
Unspecified Tissue Injury	27	27
Reaction	19	19
Neuropathy	19	19
Blood Loss	17	17
Swelling	16	16
Rash	14	14
Ambulation Difficulties	14	14
Impaired Healing	13	13
Intraoperative Pain	12	12
Hemorrhage/Bleeding	12	12
Cardiac Arrest	12	12
Dysphagia/ Odynophagia	11	11
Fever	11	11
Vertebral Fracture	11	11
Weakness	10	10
Dizziness	9	9
Paraplegia	9	9
Ulcer	8	8
Pressure Sores	8	8
Hypoesthesia	8	8
Intervertebral Disc Compression or Protrusion	8	8
Paresis	8	8
Local Reaction	7	7
Abscess	7	7
Physical Asymmetry	7	7
Dyspnea	6	6
Tingling	6	6
Thrombosis	6	6
Inflammation	6	6
Loss of Range of Motion	6	6
Muscle Weakness	5	5
Arthritis	5	5
Fatigue	5	5
Cerebrospinal Fluid Leakage	5	5
Malunion of Bone	5	5
Disability	5	5
Neck Pain	5	5
Sudden Cardiac Death	4	4
Respiratory Failure	4	4
Joint Disorder	4	4
Implant Pain	4	4
Foreign Body Reaction	4	4
Calcium Deposits/Calcification	4	4
Internal Organ Perforation	4	4
Rupture	3	3
Hernia	3	3
Autoimmune Reaction	3	3
Bacterial Infection	3	3
Wound Dehiscence	3	3
Unspecified Vascular Problem	3	3
Constipation	3	3
Depression	3	3
Collapse	3	3
Sedation	3	3
Perforation of Esophagus	2	2
Convulsion/Seizure	2	2
Cancer	2	2
Swelling/ Edema	2	2
Abdominal Pain	2	2
Damage to Ligament(s)	2	2
Muscle Spasm(s)	2	2
Extravasation	2	2
Skin Irritation	2	2
Perforation of Vessels	2	2

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