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	3
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
INTELIVATION LLC
	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
S.M.A.I.O
	SUBSTANTIALLY EQUIVALENT	1
SAFE ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	2
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	11
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	2
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	1362	1363

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	2067	2067
Adverse Event Without Identified Device or Use Problem	1433	1433
Fracture	1105	1105
Material Deformation	800	800
Migration	771	771
Loose or Intermittent Connection	615	615
Migration or Expulsion of Device	442	442
Detachment of Device or Device Component	345	345
Device Slipped	307	307
Loosening of Implant Not Related to Bone-Ingrowth	275	275
Unintended Movement	270	270
Device Dislodged or Dislocated	266	267
Device Operates Differently Than Expected	224	224
Appropriate Term/Code Not Available	164	164
Device-Device Incompatibility	164	164
Material Twisted/Bent	160	160
Mechanical Problem	159	159
Torn Material	158	158
Material Separation	121	121
Insufficient Information	104	104
Disassembly	104	104
Material Fragmentation	100	100
Material Split, Cut or Torn	100	100
Failure to Align	86	86
Material Integrity Problem	81	81
Detachment Of Device Component	72	72
Malposition of Device	62	62
Difficult to Remove	57	57
No Apparent Adverse Event	51	51
Mechanical Jam	47	47
Biocompatibility	44	44
Patient Device Interaction Problem	43	43
Metal Shedding Debris	43	43
Crack	40	40
Use of Device Problem	36	36
Calibration Problem	34	34
Fitting Problem	33	33
Compatibility Problem	30	30
Device Damaged by Another Device	29	29
Disconnection	27	27
Positioning Problem	25	25
Bent	25	25
Difficult to Insert	24	24
Naturally Worn	22	22
Patient-Device Incompatibility	21	21
Noise, Audible	20	20
Device Markings/Labelling Problem	20	20
Entrapment of Device	19	19
Corroded	18	18
Separation Problem	18	18
Improper or Incorrect Procedure or Method	17	17
Device Inoperable	16	16
Failure To Adhere Or Bond	16	16
Mechanics Altered	12	12
Premature Separation	11	11
Failure to Osseointegrate	11	11
Unstable	10	10
Inadequacy of Device Shape and/or Size	9	9
Separation Failure	9	9
Device Issue	8	8
Peeled/Delaminated	7	7
Failure to Disconnect	7	7
Physical Resistance/Sticking	7	7
Connection Problem	7	7
Osseointegration Problem	5	5
Unstable Capture Threshold	5	5
Product Quality Problem	5	5
Misassembled	5	5
Nonstandard Device	5	5
Device Handling Problem	5	5
Installation-Related Problem	5	5
Material Protrusion/Extrusion	5	5
Packaging Problem	5	5
Device Operational Issue	5	5
Misassembled During Installation	4	4
Positioning Failure	4	4
Scratched Material	4	4
Dull, Blunt	4	4
Contamination /Decontamination Problem	4	4
Difficult to Advance	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Leak/Splash	3	3
Flaked	2	2
Material Frayed	2	2
Misconnection	2	2
Unintended System Motion	2	2
Device Appears to Trigger Rejection	2	2
Material Rupture	2	2
Solder Joint Fracture	2	2
Device Contaminated During Manufacture or Shipping	2	2
Material Distortion	2	2
Material Disintegration	2	2
Difficult To Position	2	2
Off-Label Use	2	2
Structural Problem	2	2
Deformation Due to Compressive Stress	2	2
Component Incompatible	2	2
Protective Measures Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Output Problem	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	1268	1268
Failure of Implant	1147	1148
Injury	1038	1038
No Clinical Signs, Symptoms or Conditions	926	927
No Consequences Or Impact To Patient	734	734
No Information	374	374
No Patient Involvement	278	278
Unspecified Infection	268	268
Spinal Column Injury	236	236
Not Applicable	200	200
Non-union Bone Fracture	157	157
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	152	152
Insufficient Information	126	126
Bone Fracture(s)	111	111
Foreign Body In Patient	109	109
Device Embedded In Tissue or Plaque	97	97
Nerve Damage	79	79
Hypersensitivity/Allergic reaction	77	77
Patient Problem/Medical Problem	62	62
Neurological Deficit/Dysfunction	58	58
Fall	54	54
Discomfort	52	52
Post Operative Wound Infection	51	51
Spinal Cord Injury	42	42
Death	41	41
Numbness	38	38
Inadequate Osseointegration	35	35
Reaction	35	35
Stenosis	34	34
Paralysis	34	34
Tissue Damage	34	34
Osteolysis	33	33
Impaired Healing	29	29
Itching Sensation	28	28
Limited Mobility Of The Implanted Joint	27	27
Unspecified Tissue Injury	24	24
Sedation	23	23
Neuropathy	23	23
Hematoma	22	22
Blood Loss	20	20
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
Fever	11	11
Weakness	11	11
Vertebral Fracture	11	11
Dizziness	9	9
Hemorrhage/Bleeding	9	9
Paraplegia	8	8
Abscess	8	8
Paresis	8	8
Intervertebral Disc Compression or Protrusion	8	8
Pressure Sores	8	8
Hypoesthesia	8	8
Physical Asymmetry	7	7
Ulcer	7	7
Cerebrospinal Fluid Leakage	7	7
Necrosis	7	7
Tingling	7	7
Local Reaction	7	7
Disability	6	6
Dyspnea	6	6
Inflammation	6	6
Loss of Range of Motion	6	6
Sudden Cardiac Death	6	6
Collapse	6	6
Thrombosis	6	6
Neck Pain	5	5
Fatigue	5	5
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
Malunion of Bone	4	4
Wound Dehiscence	4	4
Calcium Deposits/Calcification	4	4
Muscle Weakness	4	4
Respiratory Failure	4	4
Unspecified Vascular Problem	3	3
Hernia	3	3
Muscle Spasm(s)	3	3
Autoimmune Reaction	3	3
Constipation	3	3
Depression	3	3
Myocardial Infarction	3	3
Damage to Ligament(s)	2	2
Abdominal Pain	2	2
Infection, Pyrogenic	2	2
Scar Tissue	2	2
Complaint, Ill-Defined	2	2
Implant Pain	2	2
Swelling/ Edema	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