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	7
ALTUS PARTNERS, LLC
	SUBSTANTIALLY EQUIVALENT	5
ALTUS SPINE
	SUBSTANTIALLY EQUIVALENT	1
ARTFX MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
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	1
BAUI BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
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	7
CG BIO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
CHIRAL SURGICAL
	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
DIO MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
EVOLUTION SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
G SURGICAL LLC
	SUBSTANTIALLY EQUIVALENT	2
GBS COMMONWEALTH CO., LTD.
	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
GRAFTON MEDICAL ALLIANCE
	SUBSTANTIALLY EQUIVALENT	1
ICOTEC AG
	SUBSTANTIALLY EQUIVALENT	2
IMPLANET, S.A.
	SUBSTANTIALLY EQUIVALENT	1
INDIUS MEDICAL TECHNOLOGIES PVT. LTD.
	SUBSTANTIALLY EQUIVALENT	1
INNOVATIVE SURGICAL DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	5
INTEGRITY IMPLANTS INC.
	SUBSTANTIALLY EQUIVALENT	2
INTEGRITY IMPLANTS, INC
	SUBSTANTIALLY EQUIVALENT	1
INTELIVATION LLC
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU TRAUHUI MEDICAL INSTRUMENT CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
JMT 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	2
KALITEC MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
L&K BIOMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	10
LIFE SPINE INC.
	SUBSTANTIALLY EQUIVALENT	3
LIFE SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	4
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	3
MEDICREA INTERNATIONAL
	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	1
MEDTRONIC
	SUBSTANTIALLY EQUIVALENT	4
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	8
MEDYNUS INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDYSSEY USA, INC.
	SUBSTANTIALLY EQUIVALENT	2
MIRUS, LLC
	SUBSTANTIALLY EQUIVALENT	4
NANOVIS LLC
	SUBSTANTIALLY EQUIVALENT	1
NANOVIS SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
NEXT ORTHOSURGICAL
	SUBSTANTIALLY EQUIVALENT	1
NEXUS SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
NEXXT SPINE LLC
	SUBSTANTIALLY EQUIVALENT	2
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	3
NVISION BIOMEDICAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
ORION BIOTECH INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHO DEVELOPMENT CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ORTHOCIRCLE SPINE
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPEDIATRICS CORP.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPEDIATRICS, CORP
	SUBSTANTIALLY EQUIVALENT	2
OSSEUS FUSION SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
OSTEOCENTRIC TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
PAONAN BIOTECH CO., LTD.
	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
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	2
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	1
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	9
SEOHANCARE 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	2
SIGNATURE ORTHOPAEDICS PTY LTD.
	SUBSTANTIALLY EQUIVALENT	1
SILONY MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
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 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	2
SPINEWAY SA
	SUBSTANTIALLY EQUIVALENT	1
SPINEWELDING AG
	SUBSTANTIALLY EQUIVALENT	1
STRYKER SPINE
	SUBSTANTIALLY EQUIVALENT	2
SURGALIGN SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
TAEYEON MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TDM CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
U&I CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ULRICH MEDICAL USA
	SUBSTANTIALLY EQUIVALENT	2
VALORUS SPINE
	SUBSTANTIALLY EQUIVALENT	1
VY SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
WILTROM CORPORATION LIMITED
	SUBSTANTIALLY EQUIVALENT	2
X-SPINE SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZAVATION MEDICAL PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	2
ZAVATION MEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	3
ZIMMER BIOMET SPINE, INC
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER BIOMET SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2018	1684	1684
2019	1915	1915
2020	2066	2066
2021	1735	1737
2022	1340	1340
2023	527	527

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1610	1610
Adverse Event Without Identified Device or Use Problem	1452	1452
Fracture	1089	1089
Migration	1018	1019
Material Deformation	809	809
Loosening of Implant Not Related to Bone-Ingrowth	410	410
Loose or Intermittent Connection	392	392
Detachment of Device or Device Component	370	370
Device Slipped	316	316
Material Twisted/Bent	269	269
Device-Device Incompatibility	231	231
Device Dislodged or Dislocated	223	224
Migration or Expulsion of Device	218	218
Unintended Movement	171	171
Mechanical Problem	148	148
Appropriate Term/Code Not Available	121	121
Material Separation	111	111
Material Split, Cut or Torn	103	103
Material Fragmentation	91	91
Insufficient Information	84	84
Device Operates Differently Than Expected	79	79
Material Integrity Problem	71	71
Malposition of Device	61	61
No Apparent Adverse Event	59	59
Patient Device Interaction Problem	55	55
Biocompatibility	53	53
Mechanical Jam	46	46
Use of Device Problem	43	43
Crack	42	42
Compatibility Problem	39	39
Calibration Problem	34	34
Torn Material	32	32
Mechanics Altered	30	30
Disassembly	30	30
Entrapment of Device	30	30
Separation Problem	29	29
Difficult to Remove	28	28
Failure to Align	28	28
Patient-Device Incompatibility	26	26
Disconnection	26	26
Premature Separation	22	22
Improper or Incorrect Procedure or Method	21	21
Noise, Audible	18	18
Detachment Of Device Component	16	16
Separation Failure	15	15
Failure to Osseointegrate	15	15
Corroded	14	14
Positioning Problem	13	13
Physical Resistance/Sticking	12	12
Expulsion	11	11
Naturally Worn	10	10
Osseointegration Problem	10	10
Bent	10	10
Difficult to Insert	10	10
Inadequacy of Device Shape and/or Size	9	9
Device Damaged by Another Device	9	9
Activation, Positioning or Separation Problem	8	8
Device Markings/Labelling Problem	7	7
Device Handling Problem	7	7
Difficult to Advance	6	6
Scratched Material	6	6
Metal Shedding Debris	6	6
Positioning Failure	6	6
Peeled/Delaminated	6	6
Product Quality Problem	5	5
Unintended System Motion	5	5
Installation-Related Problem	5	5
Contamination /Decontamination Problem	5	5
Unstable Capture Threshold	5	5
Misassembled During Installation	5	5
Failure to Disconnect	4	4
Packaging Problem	4	4
Nonstandard Device	4	4
Misassembled	4	4
Fitting Problem	4	4
Unstable	4	4
Material Rupture	3	3
Deformation Due to Compressive Stress	3	3
Device Appears to Trigger Rejection	3	3
Leak/Splash	3	3
Therapeutic or Diagnostic Output Failure	3	3
Device Operational Issue	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Device Contaminated During Manufacture or Shipping	2	2
Connection Problem	2	2
Protective Measures Problem	2	2
Output Problem	2	2
Material Protrusion/Extrusion	2	2
Difficult to Fold, Unfold or Collapse	2	2
Material Frayed	2	2
Component Incompatible	2	2
Material Disintegration	2	2
Flaked	2	2
Structural Problem	2	2
Solder Joint Fracture	2	2
Residue After Decontamination	2	2
Off-Label Use	2	2
Sticking	1	1
Unexpected Therapeutic Results	1	1
Device Damaged Prior to Use	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1954	1956
No Code Available	1423	1423
No Known Impact Or Consequence To Patient	1404	1404
Pain	1062	1062
Failure of Implant	868	869
No Consequences Or Impact To Patient	654	654
Injury	560	560
Unspecified Infection	475	475
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	288	288
Insufficient Information	276	276
Spinal Column Injury	219	219
Not Applicable	182	182
No Patient Involvement	157	157
No Information	153	153
Foreign Body In Patient	134	134
Non-union Bone Fracture	101	101
Bone Fracture(s)	100	100
Nerve Damage	92	92
Device Embedded In Tissue or Plaque	85	85
Hypersensitivity/Allergic reaction	78	78
Post Operative Wound Infection	67	67
Osteolysis	59	59
Patient Problem/Medical Problem	57	57
Inadequate Osseointegration	46	46
Spinal Cord Injury	46	46
Hematoma	46	46
Neurological Deficit/Dysfunction	46	46
Unspecified Tissue Injury	44	44
Paralysis	41	41
Numbness	38	38
Tissue Damage	33	33
Discomfort	31	31
Death	30	30
Itching Sensation	29	29
Fall	27	27
Limited Mobility Of The Implanted Joint	26	26
Stenosis	25	25
Vertebral Fracture	20	20
Cerebrospinal Fluid Leakage	20	20
Unspecified Nervous System Problem	17	17
Swelling	16	16
Physical Asymmetry	16	16
Neuropathy	15	15
Inflammation	15	15
Ambulation Difficulties	15	15
Reaction	15	15
Rash	14	14
Dysphagia/ Odynophagia	14	14
Hemorrhage/Bleeding	13	13
Cardiac Arrest	13	13
Blood Loss	12	12
Impaired Healing	11	11
Fever	11	11
Intervertebral Disc Compression or Protrusion	11	11
Skin Tears	10	10
Dizziness	9	9
Weakness	8	8
Hypoesthesia	8	8
Deformity/ Disfigurement	8	8
Ulcer	8	8
Intraoperative Pain	8	8
Wound Dehiscence	8	8
Paresis	8	8
Malunion of Bone	8	8
Implant Pain	8	8
Joint Laxity	7	7
Muscle Weakness	7	7
Local Reaction	7	7
Abscess	7	7
Bacterial Infection	7	7
Fatigue	7	7
Purulent Discharge	7	7
Dyspnea	6	6
Loss of Range of Motion	6	6
Tissue Breakdown	6	6
Decreased Sensitivity	6	6
Unspecified Musculoskeletal problem	6	6
Paresthesia	6	6
Neck Pain	5	5
Thromboembolism	5	5
Disability	5	5
Paraplegia	5	5
Perforation of Vessels	5	5
Thrombosis	5	5
Pulmonary Embolism	5	5
Arthritis	4	4
Calcium Deposits/Calcification	4	4
Foreign Body Reaction	4	4
Internal Organ Perforation	4	4
Pocket Erosion	4	4
Respiratory Failure	4	4
Joint Disorder	4	4
Pressure Sores	4	4
Tingling	4	4
Embolism/Embolus	4	4
Thrombosis/Thrombus	4	4
Swelling/ Edema	4	4
Metal Related Pathology	4	4
Osteomyelitis	3	3
Unspecified Vascular Problem	3	3

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	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	Icotec Ag	II	Dec-19-2022
9	Innovasis, Inc	II	Feb-20-2018
10	Integrity Implants Inc.	II	Dec-05-2022
11	Integrity Implants Inc.	II	Dec-05-2022
12	Medicrea International	II	Mar-02-2020
13	Medicrea International	II	Dec-30-2019
14	Medtronic Sofamor Danek USA Inc	II	Aug-03-2018
15	OrthoPediatrics Corp	II	Jul-30-2020
16	SAFE ORTHOPAEDICS LLC	II	Aug-24-2022
17	SPINEART SA	II	Jun-28-2021
18	U&I CORP.	II	Jul-20-2020
19	Zimmer Biomet Spine Inc.	II	Feb-22-2019
20	Zimmer Biomet, Inc.	II	Dec-15-2020
21	Zimmer Biomet, Inc.	II	Jun-02-2020