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	1
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	6
ALTUS PARTNERS, LLC
	SUBSTANTIALLY EQUIVALENT	3
ALTUS SPINE
	SUBSTANTIALLY EQUIVALENT	1
ARTFX MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
ASTURA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
AUXEIN MEDICAL PRIVATE LIMITED/71164
	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	1
BK MEDITECH, CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BLACK BOX MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
CALVARY SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
CAPTIVA SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARBOFIX ORTHOPEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	6
CARBOFIX ORTHOPEDICS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
CG BIO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
COLIGNE AG
	SUBSTANTIALLY EQUIVALENT	1
CORELINK, LLC
	SUBSTANTIALLY EQUIVALENT	2
CORENTEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CURITEVA, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIO MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
EVOLUTION SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
G SURGICAL LLC
	SUBSTANTIALLY EQUIVALENT	3
GBS COMMONWEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GETSET SURGICAL, SA
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	2
GLOBUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
GM DOS REIS INDUSTRIA E COMERICO LTDA
	SUBSTANTIALLY EQUIVALENT	1
GRAFTON MEDICAL ALLIANCE
	SUBSTANTIALLY EQUIVALENT	1
GS MEDICAL CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
ICOTEC AG
	SUBSTANTIALLY EQUIVALENT	3
IMPLANET, S.A.
	SUBSTANTIALLY EQUIVALENT	1
INDIUS MEDICAL TECHNOLOGIES PVT. LTD.
	SUBSTANTIALLY EQUIVALENT	1
INNOSYS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
INNOVATIVE SURGICAL DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	4
INTEGRITY IMPLANTS INC.
	SUBSTANTIALLY EQUIVALENT	2
INTEGRITY IMPLANTS, INC
	SUBSTANTIALLY EQUIVALENT	1
INTELIVATION LLC
	SUBSTANTIALLY EQUIVALENT	1
JMT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JMT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JOIMAX GMBH
	SUBSTANTIALLY EQUIVALENT	1
K&J CONSULTING CORP.
	SUBSTANTIALLY EQUIVALENT	1
K2M INC.
	SUBSTANTIALLY EQUIVALENT	1
KALITEC MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
L&K BIOMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	8
LIFE SPINE INC.
	SUBSTANTIALLY EQUIVALENT	3
LIFE SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	5
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	3
MEDICREA INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	3
MEDOS INTERNATIONAL SÀRL
	SUBSTANTIALLY EQUIVALENT	1
MEDOS-INTERNATIONAL, SARL
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC
	SUBSTANTIALLY EQUIVALENT	4
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	7
MEDYNUS INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDYSSEY USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
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	2
NEXXT SPINE LLC
	SUBSTANTIALLY EQUIVALENT	2
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	3
ORION BIOTECH INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHO DEVELOPMENT CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ORTHOCIRCLE SPINE
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPEDIATRICS CORP.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPEDIATRICS, CORP
	SUBSTANTIALLY EQUIVALENT	1
OSSEUS FUSION SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
OSTEOCENTRIC TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
OSTEOMED INDÚSTRIA E COMÉRCIO DE IMPLANTES LTDA
	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
RELIANCE MEDICAL SYSTEMS, LLC
	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	2
S.M.A.I.O.
	SUBSTANTIALLY EQUIVALENT	1
SAFE ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
SAGICO VA USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
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	3
SILONY MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
SOLCO BIOMEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SOLCO BIOMEDICAL COPANY INDIA PRIVATE LIMITED
	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	3
SPINEART
	SUBSTANTIALLY EQUIVALENT	4
SPINEART SA
	SUBSTANTIALLY EQUIVALENT	1
SPINECRAFT, LLC
	SUBSTANTIALLY EQUIVALENT	2
SPINEWAY
	SUBSTANTIALLY EQUIVALENT	1
SPINEWAY SA
	SUBSTANTIALLY EQUIVALENT	1
SPINEWELDING AG
	SUBSTANTIALLY EQUIVALENT	1
STRYKER INSTRUMENTS
	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
ULRICH MEDICAL USA
	SUBSTANTIALLY EQUIVALENT	2
VY SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
WILTROM CORPORATION LIMITED
	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
ZIMVIE SPINE (ZIMMER BIOMET SPINE, INC.)
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2019	1915	1915
2020	2076	2076
2021	1735	1737
2022	1340	1340
2023	920	920
2024	515	515

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1734	1734
Break	1265	1265
Migration	1048	1049
Fracture	951	951
Material Deformation	655	655
Loosening of Implant Not Related to Bone-Ingrowth	417	417
Detachment of Device or Device Component	337	337
Device Slipped	305	305
Material Twisted/Bent	282	282
Device-Device Incompatibility	230	230
Loose or Intermittent Connection	209	209
Device Dislodged or Dislocated	207	208
Insufficient Information	144	144
Unintended Movement	140	140
Mechanical Problem	132	132
Migration or Expulsion of Device	123	123
Appropriate Term/Code Not Available	110	110
Material Separation	108	108
Material Fragmentation	92	92
Material Split, Cut or Torn	72	72
Material Integrity Problem	70	70
Malposition of Device	65	65
No Apparent Adverse Event	60	60
Improper or Incorrect Procedure or Method	59	59
Patient Device Interaction Problem	56	56
Biocompatibility	47	47
Use of Device Problem	44	44
Mechanical Jam	42	42
Crack	37	37
Compatibility Problem	35	35
Entrapment of Device	32	32
Mechanics Altered	31	31
Separation Problem	28	28
Patient-Device Incompatibility	25	25
Premature Separation	24	24
Difficult to Remove	23	23
Failure to Align	18	18
Noise, Audible	17	17
Inaccurate Information	17	17
Failure to Osseointegrate	17	17
Separation Failure	16	16
Disconnection	15	15
Corroded	14	14
Expulsion	12	12
Physical Resistance/Sticking	12	12
Osseointegration Problem	10	10
Inadequacy of Device Shape and/or Size	9	9
Device Damaged by Another Device	9	9
Naturally Worn	9	9
Positioning Problem	8	8
Difficult to Insert	8	8
Activation, Positioning or Separation Problem	8	8
Product Quality Problem	7	7
Difficult to Advance	7	7
Device Handling Problem	7	7
Positioning Failure	7	7
Off-Label Use	6	6
Scratched Material	6	6
Calibration Problem	6	6
Manufacturing, Packaging or Shipping Problem	5	5
Peeled/Delaminated	5	5
Misassembled During Installation	5	5
Contamination /Decontamination Problem	5	5
Unintended System Motion	5	5
Misassembled	4	4
Unstable	4	4
Contamination	4	4
Failure to Disconnect	4	4
Material Rupture	3	3
Device Markings/Labelling Problem	3	3
Nonstandard Device	3	3
Packaging Problem	3	3
Leak/Splash	3	3
Installation-Related Problem	3	3
Device Appears to Trigger Rejection	3	3
Therapeutic or Diagnostic Output Failure	3	3
Deformation Due to Compressive Stress	3	3
Connection Problem	2	2
Residue After Decontamination	2	2
Material Frayed	2	2
Solder Joint Fracture	2	2
Human-Device Interface Problem	2	2
Material Protrusion/Extrusion	2	2
Misassembly by Users	2	2
Difficult to Fold, Unfold or Collapse	2	2
Fitting Problem	2	2
Defective Device	2	2
Output Problem	2	2
Fluid/Blood Leak	1	1
Material Too Soft/Flexible	1	1
Difficult to Open or Remove Packaging Material	1	1
Microbial Contamination of Device	1	1
Material Erosion	1	1
Flaked	1	1
Sharp Edges	1	1
Dull, Blunt	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Accessory Incompatible	1	1
Device Reprocessing Problem	1	1
Expiration Date Error	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2181	2183
No Code Available	1140	1140
Pain	978	978
No Known Impact Or Consequence To Patient	858	858
Failure of Implant	779	780
No Consequences Or Impact To Patient	510	510
Insufficient Information	501	501
Unspecified Infection	493	493
Injury	465	465
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	291	291
Osteolysis	195	195
Non-union Bone Fracture	158	158
Nerve Damage	152	152
Foreign Body In Patient	124	124
Bone Fracture(s)	103	103
Hypersensitivity/Allergic reaction	89	89
Post Operative Wound Infection	85	85
No Information	84	84
Joint Laxity	83	83
Device Embedded In Tissue or Plaque	68	68
Unspecified Tissue Injury	58	58
Spinal Cord Injury	51	51
Patient Problem/Medical Problem	50	50
Inadequate Osseointegration	47	47
Hematoma	47	47
No Patient Involvement	45	45
Neurological Deficit/Dysfunction	42	42
Paralysis	42	42
Numbness	39	39
Spinal Column Injury	36	36
Impaired Healing	35	35
Unspecified Nervous System Problem	32	32
Swelling/ Edema	28	28
Discomfort	27	27
Limited Mobility Of The Implanted Joint	26	26
Tissue Damage	26	26
Death	25	25
Stenosis	25	25
Vertebral Fracture	25	25
Pressure Sores	23	23
Cerebrospinal Fluid Leakage	22	22
Fall	21	21
Not Applicable	21	21
Itching Sensation	19	19
Physical Asymmetry	18	18
Swelling	16	16
Dysphagia/ Odynophagia	16	16
Hemorrhage/Bleeding	15	15
Inflammation	15	15
Rash	14	14
Cardiac Arrest	14	14
Ambulation Difficulties	13	13
Deformity/ Disfigurement	13	13
Fever	11	11
Neuropathy	11	11
Intervertebral Disc Compression or Protrusion	11	11
Implant Pain	10	10
Muscle Weakness	10	10
Foreign Body Reaction	10	10
Skin Tears	10	10
Decreased Sensitivity	9	9
Pulmonary Embolism	9	9
Paraplegia	8	8
Thromboembolism	8	8
Paresthesia	8	8
Malunion of Bone	8	8
Hypoesthesia	8	8
Ulcer	8	8
Loss of Range of Motion	7	7
Weakness	7	7
Reaction	7	7
Blood Loss	7	7
Abscess	7	7
Fatigue	7	7
Purulent Discharge	7	7
Unspecified Musculoskeletal problem	7	7
Wound Dehiscence	6	6
Bacterial Infection	6	6
Paresis	6	6
Tissue Breakdown	6	6
Inadequate Pain Relief	6	6
Perforation of Vessels	6	6
Hernia	5	5
Neck Pain	5	5
Metal Related Pathology	5	5
Thrombosis	5	5
Pocket Erosion	4	4
Local Reaction	4	4
Internal Organ Perforation	4	4
Necrosis	4	4
Calcium Deposits/Calcification	4	4
Embolism/Embolus	4	4
Thrombosis/Thrombus	4	4
Intraoperative Pain	4	4
Respiratory Failure	4	4
Disability	4	4
Joint Disorder	4	4
Tingling	3	3
Rupture	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	CTL Medical Corporation	II	Mar-20-2019
4	Clariance Inc	III	Jul-18-2019
5	Howmedica Osteonics Corp.	II	Aug-05-2019
6	Icotec Ag	II	Dec-19-2022
7	Integrity Implants Inc.	II	Dec-05-2022
8	Integrity Implants Inc.	II	Dec-05-2022
9	Medicrea International	II	Mar-02-2020
10	Medicrea International	II	Dec-30-2019
11	OrthoPediatrics Corp	II	Jul-30-2020
12	SAFE ORTHOPAEDICS LLC	II	Aug-24-2022
13	SPINEART SA	II	Jun-28-2021
14	U&I CORP.	II	Jul-20-2020
15	XTANT Medical Holdings, Inc	II	Jan-29-2024
16	Zimmer Biomet Spine Inc.	II	Jan-04-2024
17	Zimmer Biomet Spine Inc.	II	Feb-22-2019
18	Zimmer Biomet, Inc.	II	Dec-15-2020
19	Zimmer Biomet, Inc.	II	Jun-02-2020