TPLC - Total Product Life Cycle

• Device: appliance, fixation, spinal intervertebral body
• Product Code: KWQ
• Regulation Number: 888.3060
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
4WEB MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
4WEB, INC.
	SUBSTANTIALLY EQUIVALENT	1
A JOHNSON & JOHNSON COMPANY
	SUBSTANTIALLY EQUIVALENT	1
ACCEL SPINE
	SUBSTANTIALLY EQUIVALENT	2
AEGIS SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
AESCULAP IMPLANT SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	2
ALLIANCE PARTNERS, LLC
	SUBSTANTIALLY EQUIVALENT	2
ALPHATEC SPINE INC.
	SUBSTANTIALLY EQUIVALENT	1
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	6
ALTUS PARTNERS, LLC
	SUBSTANTIALLY EQUIVALENT	2
AMENDIA, INC
	SUBSTANTIALLY EQUIVALENT	1
AMENDIA, INC.
	SUBSTANTIALLY EQUIVALENT	1
APOLLO SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
ARCHIMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARTFX MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
ASTURA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ATLAS SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
AURORA SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
AXIS ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
BACKROADS CONSULTING, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET SPINE
	SUBSTANTIALLY EQUIVALENT	1
BIOMET SPINE (AKA EBI, LLC)
	SUBSTANTIALLY EQUIVALENT	1
BLACKSTONE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
CAMBER SPINE TECHNOLOGIES LLC
	SUBSTANTIALLY EQUIVALENT	1
CAMBER SPINE TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
CAPTIVA SPINE
	SUBSTANTIALLY EQUIVALENT	1
CARBOFIX ORTHOPEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARDO MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
CHOICE SPINE, LP
	SUBSTANTIALLY EQUIVALENT	2
CHOICESPINE, LP
	SUBSTANTIALLY EQUIVALENT	1
CLARIANCE
	SUBSTANTIALLY EQUIVALENT	1
CORE-NEXUS
	SUBSTANTIALLY EQUIVALENT	1
CORELINK LLC
	SUBSTANTIALLY EQUIVALENT	3
CORELINK, LLC
	SUBSTANTIALLY EQUIVALENT	2
CORENTEC CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
CTL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
CURITEVA, INC.
	SUBSTANTIALLY EQUIVALENT	1
CURITEVA, LLC
	SUBSTANTIALLY EQUIVALENT	2
CUSTOM SPINE
	SUBSTANTIALLY EQUIVALENT	1
CUSTOM SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEGEN MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
DEGEN MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
DEPUY SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIO MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DIO MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
DOUBLE MEDICAL TECHNOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	1
EDEN SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
EFFORTMED, LLC
	SUBSTANTIALLY EQUIVALENT	1
EISERTECH, LLC
	SUBSTANTIALLY EQUIVALENT	2
ELITE SURGICAL SUPPLIES (PTY) LTD
	SUBSTANTIALLY EQUIVALENT	1
EMINENT SPINE
	SUBSTANTIALLY EQUIVALENT	3
EMINENT SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
EVOLUTION SPINE
	SUBSTANTIALLY EQUIVALENT	2
EVOLUTION SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
FELLOWSHIP OF ORTHOPAEDIC RESEARCHERS, INC.
	SUBSTANTIALLY EQUIVALENT	1
FLOSPINE
	SUBSTANTIALLY EQUIVALENT	1
G SURGICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GBS COMMONWEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
GENESYS SPINE
	SUBSTANTIALLY EQUIVALENT	6
GLOBUS MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	5
GLOBUS MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
GOLD STANDARD ORTHOPEDICS LLC
	SUBSTANTIALLY EQUIVALENT	1
GS MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUVEXEL CO., LTD
	SUBSTANTIALLY EQUIVALENT	3
ICOTEC AG
	SUBSTANTIALLY EQUIVALENT	2
INDIUS MEDICAL TECHNOLOGIES PVT. LTD.
	SUBSTANTIALLY EQUIVALENT	1
INNOVASIS, INC.
	SUBSTANTIALLY EQUIVALENT	2
INTELLIGENT IMPLANT SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
JEIL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
K&J CONSULTING CORP.
	SUBSTANTIALLY EQUIVALENT	1
K2M
	SUBSTANTIALLY EQUIVALENT	3
K2M INC.
	SUBSTANTIALLY EQUIVALENT	2
K2M, INC
	SUBSTANTIALLY EQUIVALENT	1
K2M, INC.
	SUBSTANTIALLY EQUIVALENT	9
KAHTNU SURGICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
KALITEC DIRECT, LLC
	SUBSTANTIALLY EQUIVALENT	2
KYOCERA MEDICAL TECHNOLOGIES, INC. (KMTI)
	SUBSTANTIALLY EQUIVALENT	1
L & K BIOMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
L&K BIOMED CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
L&K BIOMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
LANX, INC.
	SUBSTANTIALLY EQUIVALENT	2
LDR SPINE USA
	SUBSTANTIALLY EQUIVALENT	1
LIFE SPINE
	SUBSTANTIALLY EQUIVALENT	2
LIFE SPINE INC.
	SUBSTANTIALLY EQUIVALENT	1
LIFE SPINE, INC
	SUBSTANTIALLY EQUIVALENT	3
LIFE SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDACTA INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL DESIGN LLC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL DESIGNS, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA INTERNATIONAL S.A
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
MEDITECH SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	6
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	4
MEDTRONIC SOFAMOR DANEK USA, INC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	4
MEDTRONIC SOFAMOR DANEK, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDYNUS INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDYSSEY USA, INC.
	SUBSTANTIALLY EQUIVALENT	3
MET ONE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
MIKRON MAKINA SANAYI VE TICARET LTD. STI.
	SUBSTANTIALLY EQUIVALENT	1
MIRUS, LLC
	SUBSTANTIALLY EQUIVALENT	3
NANOVIS SPINE LLC
	SUBSTANTIALLY EQUIVALENT	2
NEOORTHO PRODUCTOS ORTHOPEDICOS S/A
	SUBSTANTIALLY EQUIVALENT	1
NEUROSTRUCTURES, INC.
	SUBSTANTIALLY EQUIVALENT	4
NEUROSTRUCTURES, LLC
	SUBSTANTIALLY EQUIVALENT	2
NEXUS SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
NEXXT MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
NEXXT SPINE
	SUBSTANTIALLY EQUIVALENT	1
NEXXT SPINE LLC
	SUBSTANTIALLY EQUIVALENT	2
NUTECH SPINE AND BIOLOGICS
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE, INC.
	SUBSTANTIALLY EQUIVALENT	11
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	7
NVISION BIOMEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
NVISION BIOMEDICAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	2
OAK TREE ENGINEERING, LLC.
	SUBSTANTIALLY EQUIVALENT	2
OMNI SURGICAL, L.P.
	SUBSTANTIALLY EQUIVALENT	1
OMNIA MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
ORBBO SURGICAL, LLC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX INC.
	SUBSTANTIALLY EQUIVALENT	3
ORTHOFIX US LLC
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX, INC.
	SUBSTANTIALLY EQUIVALENT	2
ORTHOPAEDIC & SPINE DEVELOPMENT
	SUBSTANTIALLY EQUIVALENT	1
OSSEUS FUSION SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
OSTEOMED IMPLANTES, LTDA
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY
	SUBSTANTIALLY EQUIVALENT	3
PIONEER SURGICAL TECHNOLOGY, INC
	SUBSTANTIALLY EQUIVALENT	2
PIONEER SURGICAL TECHNOLOGY, INC D.B.A RESOLVE SURGICAL TECH
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	2
PIONEER SURGICAL TECHNOLOGY, INC. (DBA RTI SURGICAL, INC.)
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY, INC.,
	SUBSTANTIALLY EQUIVALENT	1
PRECISION SPINE
	SUBSTANTIALLY EQUIVALENT	1
PRECISION SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	3
PRECISION SURGERY LTD.
	SUBSTANTIALLY EQUIVALENT	2
PRISM SURGICAL DESIGN PTY LTD.
	SUBSTANTIALLY EQUIVALENT	1
QUALGENIX LLC
	SUBSTANTIALLY EQUIVALENT	1
RELIANCE MEDICAL SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	2
RENOVIS SURGICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
RSB SPINE LLC.
	SUBSTANTIALLY EQUIVALENT	1
SAPPHIRE MEDICAL GROUP
	SUBSTANTIALLY EQUIVALENT	1
SCIENT'X USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	5
SEASPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
SHANGHAI SANYOU MEDICAL CO, LTD
	SUBSTANTIALLY EQUIVALENT	2
SIGNATURE ORTHOPAEDICS PTY LTD.
	SUBSTANTIALLY EQUIVALENT	2
SINTEA PLUSTEK, LLC
	SUBSTANTIALLY EQUIVALENT	1
SOLCO BIOMEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SOUTHERN MEDICAL (PTY) LTD
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ELEMENTS, INC
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ELEMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
SPINAL SIMPLICITY LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINAL USA
	SUBSTANTIALLY EQUIVALENT	2
SPINAL USA LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINE 360
	SUBSTANTIALLY EQUIVALENT	1
SPINEART
	SUBSTANTIALLY EQUIVALENT	2
SPINECRAFT LLC
	SUBSTANTIALLY EQUIVALENT	2
SPINEFRONTIER, INC.
	SUBSTANTIALLY EQUIVALENT	2
SPINENET LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINEWAY
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	3
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
SYNTHES (USA), LLC
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES SPINE
	SUBSTANTIALLY EQUIVALENT	1
TDM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TRANS1
	SUBSTANTIALLY EQUIVALENT	1
TRANS1 INCORPORATED
	SUBSTANTIALLY EQUIVALENT	2
TRANSCORP, INC.
	SUBSTANTIALLY EQUIVALENT	1
U & I CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
U&I CORP.
	SUBSTANTIALLY EQUIVALENT	1
U&I CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
ULRICH GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	3
ULRICH MEDICAL USA
	SUBSTANTIALLY EQUIVALENT	1
ULRICH MEDICAL USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
VALORUS SPINE
	SUBSTANTIALLY EQUIVALENT	1
VERTICOR, LTD
	SUBSTANTIALLY EQUIVALENT	1
VY SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
WEIGAO ORTHOPAEDIC DEVICE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
X-SPINE SYSTEMS, INC
	SUBSTANTIALLY EQUIVALENT	1
X-SPINE SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	3
XENCO MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
ZAVATION LLC
	SUBSTANTIALLY EQUIVALENT	2
ZAVATION MEDICAL PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	4
ZAVATION, LLC
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER BIOMET SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER SPINE, INC
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	5

MDR Year	MDR Reports	MDR Events
2014	545	545
2015	562	562
2016	501	501
2017	492	492
2018	340	340
2019	298	298
2020	400	400
2021	581	581
2022	395	396
2023	318	318
2024	305	305

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	853	853
Adverse Event Without Identified Device or Use Problem	819	819
Fracture	552	553
Migration	364	364
Migration or Expulsion of Device	357	357
Device Dislodged or Dislocated	226	226
Detachment of Device or Device Component	164	164
Device Slipped	159	159
Material Integrity Problem	153	153
Mechanical Problem	152	152
Insufficient Information	131	131
Device Operates Differently Than Expected	126	126
Loose or Intermittent Connection	109	109
Material Deformation	108	108
Material Fragmentation	96	96
Unintended Movement	86	86
Malposition of Device	72	72
Appropriate Term/Code Not Available	66	66
Material Twisted/Bent	64	64
Detachment Of Device Component	60	60
Bent	56	56
Material Separation	54	54
Patient Device Interaction Problem	50	50
Device-Device Incompatibility	48	48
Loosening of Implant Not Related to Bone-Ingrowth	47	47
Compatibility Problem	44	44
Biocompatibility	42	42
Patient-Device Incompatibility	40	40
Positioning Problem	38	38
Difficult to Remove	37	37
Device Damaged by Another Device	28	28
Mechanical Jam	26	26
Device Appears to Trigger Rejection	24	24
Improper or Incorrect Procedure or Method	23	23
No Apparent Adverse Event	23	23
Use of Device Problem	21	21
Material Protrusion/Extrusion	21	21
Inadequacy of Device Shape and/or Size	20	20
Dull, Blunt	20	20
Unstable	17	17
Failure to Osseointegrate	17	17
Sticking	17	17
Packaging Problem	16	16
Difficult to Insert	16	16
Naturally Worn	15	15
Separation Problem	15	15
Fitting Problem	13	13
Wrong Label	13	13
Failure To Adhere Or Bond	13	13
Loss of Osseointegration	12	12

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	832	833
No Clinical Signs, Symptoms or Conditions	810	811
Pain	629	629
No Code Available	602	602
Failure of Implant	471	471
No Consequences Or Impact To Patient	265	265
Injury	249	249
Insufficient Information	245	245
No Information	206	206
Unspecified Infection	125	125
Dysphagia/ Odynophagia	121	121
Neck Pain	111	111
Non-union Bone Fracture	106	106
Device Embedded In Tissue or Plaque	85	85
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	78	78
Impaired Healing	67	67
Nerve Damage	62	62
Foreign Body In Patient	53	53
Discomfort	50	50
Reaction	49	49
Hematoma	48	48
Implant Pain	43	43
Numbness	42	42
No Patient Involvement	39	39
Unspecified Tissue Injury	37	37
Osteolysis	35	35
Swelling	33	33
Spinal Column Injury	33	33
Bone Fracture(s)	33	33
Stenosis	32	33
Weakness	26	26
Hypersensitivity/Allergic reaction	22	22
Headache	21	21
Death	21	21
Tingling	20	20
Cerebrospinal Fluid Leakage	19	19
Post Operative Wound Infection	19	19
Patient Problem/Medical Problem	18	18
Neuropathy	17	17
Hypoesthesia	16	16
Inflammation	16	16
Physical Asymmetry	15	15
Rash	15	15
Not Applicable	15	15
Sedation	15	15
Fall	15	15
Tissue Damage	12	12
Inadequate Osseointegration	11	11
Spinal Cord Injury	11	11
Paralysis	10	10

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Implant Systems	II	Apr-25-2012
2	Alliance Partners LLC	II	Jul-07-2015
3	Alphatec Spine, Inc.	II	Jun-07-2021
4	Alphatec Spine, Inc.	II	Apr-29-2015
5	Alphatec Spine, Inc.	II	Aug-27-2012
6	Alphatec Spine, Inc.	II	Jun-02-2010
7	Amendia, Inc	II	Dec-22-2016
8	Amendia, Inc dba Spinal Elements	II	Dec-13-2017
9	Biomet Spine, LLC	II	Nov-03-2015
10	Biomet Spine, LLC	II	Sep-09-2015
11	Blackstone Medical, Inc.	II	May-26-2010
12	Captiva Spine, Inc	II	May-23-2012
13	Captiva Spine, Inc	II	May-14-2012
14	DePuy Spine, Inc.	II	Nov-19-2016
15	DePuy Spine, Inc.	II	Dec-21-2015
16	Exactech, Inc.	II	Jul-14-2015
17	Genesys Orthopedic Systems, LLC	II	Mar-08-2013
18	Innovasis, Inc	II	May-20-2020
19	Innovasis, Inc	II	May-23-2017
20	Integra LifeSciences Corp.	II	May-13-2011
21	Medtronic Sofamor Danek USA Inc	II	May-08-2018
22	Medtronic Sofamor Danek USA Inc	II	Oct-10-2012
23	Medtronic Sofamor Danek USA Inc	II	Jan-11-2012
24	Orthofix, Inc	II	Feb-25-2014
25	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	II	Mar-11-2021
26	SPINEART SA	II	Jan-13-2018
27	Spinal Solutions, LLC	II	May-27-2013
28	SpineFrontier, Inc.	II	Dec-26-2013
29	Stryker Spine	II	Apr-12-2010
30	Stryker Spine	II	Nov-24-2009
31	Stryker Spine	II	Aug-20-2009
32	Synthes (USA) Products LLC	II	Apr-20-2016
33	Synthes USA HQ, Inc.	II	Feb-04-2013
34	Synthes, Inc.	II	Sep-22-2014
35	Theken Spine Llc	II	Oct-19-2010
36	Ulrich Medical USA Inc	II	Apr-26-2017
37	Zimmer Biomet Spine Inc.	II	Feb-22-2019
38	Zimmer Inc.	II	Dec-10-2010
39	Zimmer, Inc.	II	Nov-18-2013