TPLC - Total Product Life Cycle

• Device: intervertebral fusion device with bone graft, cervical
• Definition: Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
• Product Code: ODP
• Regulation Number: 888.3080
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
4-WEB, INC.
	SUBSTANTIALLY EQUIVALENT	1
4WEB MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
4WEB, INC.
	SUBSTANTIALLY EQUIVALENT	1
ABSOLUTE ADVANTAGE MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
ACCEL SPINE
	SUBSTANTIALLY EQUIVALENT	1
ACKERMANN INSTRUMENTE GMBH
	SUBSTANTIALLY EQUIVALENT	1
ACRO COMPOSITES, LLC
	SUBSTANTIALLY EQUIVALENT	1
ACUITY SURGICAL DEVICES, LLC
	SUBSTANTIALLY EQUIVALENT	1
ADAPTIVE SPECIALTY, LLC
	SUBSTANTIALLY EQUIVALENT	1
ADDITIVE DEVICE, INC. (ADI) D/B/A RESTOR3D
	SUBSTANTIALLY EQUIVALENT	1
ADDITIVE IMPLANTS, INC
	SUBSTANTIALLY EQUIVALENT	1
ADDITIVE IMPLANTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ADDIVATION MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
AESCULAP IMPLANT SYSTEM, INC.
	SUBSTANTIALLY EQUIVALENT	1
AESCULAP IMPLANT SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ALLIANCE PARTNERS, LLC
	SUBSTANTIALLY EQUIVALENT	3
ALPHATEC SPINE INC.
	SUBSTANTIALLY EQUIVALENT	1
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ALTUS PARTNERS, LLC
	SUBSTANTIALLY EQUIVALENT	1
AMEDICA CORP.
	SUBSTANTIALLY EQUIVALENT	2
APOLLO SPINE
	SUBSTANTIALLY EQUIVALENT	1
ARTFX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ASTURA MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
ATLAS SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
AURORA SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
AXIS ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
BACK 2 BASICS DIRECT, LLC
	SUBSTANTIALLY EQUIVALENT	1
BESPOKE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
BK MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BLUSTONE SYNERGY, LLC
	SUBSTANTIALLY EQUIVALENT	1
BM KOREA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
BRIGHT SPINE, INC
	SUBSTANTIALLY EQUIVALENT	1
CAMBER SPINE
	SUBSTANTIALLY EQUIVALENT	1
CAMBER SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
CAPTIVA SPINE
	SUBSTANTIALLY EQUIVALENT	1
CAPTIVA SPINE, INC
	SUBSTANTIALLY EQUIVALENT	1
CAPTIVA SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARBOFIX ORTHPEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARDINAL SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
CHOICE SPINE, LLP
	SUBSTANTIALLY EQUIVALENT	1
CHOICESPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
CHOICESPINE, LP
	SUBSTANTIALLY EQUIVALENT	1
CLARIANCE
	SUBSTANTIALLY EQUIVALENT	1
COLIGNE, AG
	SUBSTANTIALLY EQUIVALENT	1
CORELINK LLC
	SUBSTANTIALLY EQUIVALENT	1
CORELINK, LLC
	SUBSTANTIALLY EQUIVALENT	2
CTL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
CURITEVA, INC.
	SUBSTANTIALLY EQUIVALENT	1
CURITEVA, LLC
	SUBSTANTIALLY EQUIVALENT	1
CUSTOM SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
CUTTING EDGE SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
DEGEN MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
DEPUY SPINE
	SUBSTANTIALLY EQUIVALENT	1
DIO MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
DIO MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
EISERTECH, LLC
	SUBSTANTIALLY EQUIVALENT	2
EMINENT SPINE
	SUBSTANTIALLY EQUIVALENT	1
EVOLUTION SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	3
FLOSPINE
	SUBSTANTIALLY EQUIVALENT	1
G SURGICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
G SURGICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
GBS COMMONWEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	7
GENESYS SPINE
	SUBSTANTIALLY EQUIVALENT	2
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	6
GS MEDICAL CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
GS MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HAPPE SPINE
	SUBSTANTIALLY EQUIVALENT	1
HD LIFESCIENCES LLC
	SUBSTANTIALLY EQUIVALENT	1
HT MEDICAL D.B.A. XENIX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
HT MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
ICOTEC AG
	SUBSTANTIALLY EQUIVALENT	2
IMPLANET, S.A.
	SUBSTANTIALLY EQUIVALENT	1
INNOVASIS, INC.
	SUBSTANTIALLY EQUIVALENT	5
INTEGRITY SPINE
	SUBSTANTIALLY EQUIVALENT	2
INTUITIVE SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
JEIL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
JMT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
K&J CONSULTING CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
K2M
	SUBSTANTIALLY EQUIVALENT	1
K2M, INC.
	SUBSTANTIALLY EQUIVALENT	2
K7 LLC
	SUBSTANTIALLY EQUIVALENT	1
KAHTNU SURGICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
KALITEC DIRECT, LLC
	SUBSTANTIALLY EQUIVALENT	2
KEOS
	SUBSTANTIALLY EQUIVALENT	1
L&K BIOMED CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
L&K BIOMED CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
LANX, INC.
	SUBSTANTIALLY EQUIVALENT	1
LDR SPINE USA
	SUBSTANTIALLY EQUIVALENT	1
LDR SPINE USA INC.
	SUBSTANTIALLY EQUIVALENT	1
LEGEND SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
LIFE SPINE
	SUBSTANTIALLY EQUIVALENT	1
LIFE SPINE INC.
	SUBSTANTIALLY EQUIVALENT	1
LIFE SPINE, INC
	SUBSTANTIALLY EQUIVALENT	1
LNTELIVATION, LLC
	SUBSTANTIALLY EQUIVALENT	1
LUCERO MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
MAXIM SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	2
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA
	SUBSTANTIALLY EQUIVALENT	1
MEDITECH ADVISORS, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDITECH SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	3
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANCK USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC SOFAMOR DANEK USA
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA, INC
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	4
MEDTRONIC SOFAMOR DANEK, USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDYNUS INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDYSSEY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDYSSEY USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
MET 1 TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
MET ONE TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
MIRUS, LLC
	SUBSTANTIALLY EQUIVALENT	2
MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS
	SUBSTANTIALLY EQUIVALENT	1
NANOVIS LLC
	SUBSTANTIALLY EQUIVALENT	2
NANOVIS, LLC
	SUBSTANTIALLY EQUIVALENT	2
NEUROSTRUCTURES, INC.
	SUBSTANTIALLY EQUIVALENT	3
NEXT ORTHOSURGICAL
	SUBSTANTIALLY EQUIVALENT	1
NEXUS SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
NEXXT SPINE LLC
	SUBSTANTIALLY EQUIVALENT	2
NGMEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	3
NUVASIVE, INC.
	SUBSTANTIALLY EQUIVALENT	2
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	8
NVISION BIOMEDICAL TECHNOLOGIES, INC
	SUBSTANTIALLY EQUIVALENT	1
NVISION BIOMEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
NVISION BIOMEDICAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	2
OMNI SURGICAL, LP DBA SPINE360
	SUBSTANTIALLY EQUIVALENT	1
ORBBO SURGICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
ORTHO DEVELOPMENT CORP.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX INC.
	SUBSTANTIALLY EQUIVALENT	8
ORTHOFIX, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOVITA, INC.
	SUBSTANTIALLY EQUIVALENT	1
OSSEUS FUSION SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
OSTEOMED IMPLANTES, LTDA
	SUBSTANTIALLY EQUIVALENT	1
PAONAN BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PARADIGM SPINE
	SUBSTANTIALLY EQUIVALENT	1
PINNACLE SPINE GROUP, LLC
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY, INC
	SUBSTANTIALLY EQUIVALENT	1
POROSTEON, INC.
	SUBSTANTIALLY EQUIVALENT	1
PRECIFIT MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	1
PRECISION SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
PROVIDENCE MEDICAL TECHNOLOGY, INC
	SUBSTANTIALLY EQUIVALENT	1
PROVIDENCE MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
QUALGENIX
	SUBSTANTIALLY EQUIVALENT	1
RELIANCE MEDICAL SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	6
REPUBLIC SPINE, L.L.C.
	SUBSTANTIALLY EQUIVALENT	1
RHAUSLER, INC.
	SUBSTANTIALLY EQUIVALENT	1
RSB SPINE LLC.
	SUBSTANTIALLY EQUIVALENT	1
RTI SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
RTI SURGICAL, INC. DBA RTI BIOLOGICS
	SUBSTANTIALLY EQUIVALENT	1
SAPPHIRE MEDICAL GROUP
	SUBSTANTIALLY EQUIVALENT	3
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
SEASPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI SANYOU MEDICAL CO, LTD
	SUBSTANTIALLY EQUIVALENT	1
SIGNUS MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
SILONY MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
SOLCO BIOMEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SOUTHERN MEDICAL (PTY) LTD
	SUBSTANTIALLY EQUIVALENT	1
SOUTHERN SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPECTRUM SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINAL DEVICES, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ELEMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINAL USA
	SUBSTANTIALLY EQUIVALENT	1
SPINEART
	SUBSTANTIALLY EQUIVALENT	5
SPINEART SA
	SUBSTANTIALLY EQUIVALENT	1
SPINECRAFT
	SUBSTANTIALLY EQUIVALENT	1
SPINECRAFT, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINEFRONTIER, INC.
	SUBSTANTIALLY EQUIVALENT	4
SPINENET, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINEWAY
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
STRYKER SPINE
	SUBSTANTIALLY EQUIVALENT	5
SUMMIT SPINE
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES (USA) LLC
	SUBSTANTIALLY EQUIVALENT	1
THE INSTITUTE OF MUSCULOSKELETAL SCIENCE & EDUCATION
	SUBSTANTIALLY EQUIVALENT	1
THE ORTHOPAEDIC IMPLANT COMPANY
	SUBSTANTIALLY EQUIVALENT	1
THEKEN SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
TITAN SPINE, INC
	SUBSTANTIALLY EQUIVALENT	2
TITAN SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
TRANSCORP, INC.
	SUBSTANTIALLY EQUIVALENT	2
TYBER MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	3
TYBER MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
U&I CORP.
	SUBSTANTIALLY EQUIVALENT	2
U&I CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
ULRICH MEDICAL USA
	SUBSTANTIALLY EQUIVALENT	1
ULRICH MEDICAL USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
VERTERA, INC.
	SUBSTANTIALLY EQUIVALENT	1
VY SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	5
WENZEL SPINE
	SUBSTANTIALLY EQUIVALENT	2
WENZEL SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
X-SPINE SYSTEMS, INC
	SUBSTANTIALLY EQUIVALENT	1
X-SPINE SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	3
XENCO MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	3
ZAVATION LLC
	SUBSTANTIALLY EQUIVALENT	1
ZAVATION MEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER SPINE, INC
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER TRABECULAR METAL TECHNOLOGY
	SUBSTANTIALLY EQUIVALENT	3
ZSFAB INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2014	43	43
2015	51	51
2016	37	37
2017	39	39
2018	51	51
2019	140	140
2020	86	86
2021	161	161
2022	50	50
2023	36	36
2024	28	28

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	303	303
Break	98	98
Migration	61	61
Fracture	55	55
Malposition of Device	40	40
Migration or Expulsion of Device	33	33
Patient Device Interaction Problem	26	26
No Apparent Adverse Event	14	14
Positioning Problem	13	13
Insufficient Information	13	13
Appropriate Term/Code Not Available	10	10
Device Dislodged or Dislocated	8	8
Material Integrity Problem	8	8
Device Operates Differently Than Expected	7	7
Device-Device Incompatibility	7	7
Patient-Device Incompatibility	7	7
Unintended Movement	7	7
Detachment of Device or Device Component	6	6
Material Deformation	6	6
Mechanical Problem	6	6
Device Slipped	6	6
Improper or Incorrect Procedure or Method	5	5
Loose or Intermittent Connection	5	5
Material Fragmentation	5	5
Detachment Of Device Component	5	5
Physical Resistance/Sticking	4	4
Device Issue	3	3
Difficult to Remove	3	3
Failure to Osseointegrate	3	3
Device Appears to Trigger Rejection	3	3
Inadequacy of Device Shape and/or Size	3	3
Sticking	3	3
Fitting Problem	3	3
Expiration Date Error	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Mechanical Jam	2	2
Flaked	2	2
Difficult to Insert	2	2
Use of Device Problem	2	2
Failure to Align	2	2
Bent	2	2
Solder Joint Fracture	2	2
Loss of or Failure to Bond	2	2
Nonstandard Device	2	2
Material Separation	2	2
Compatibility Problem	2	2
Expulsion	2	2
Activation, Positioning or Separation Problem	2	2
Premature Separation	1	1
Component Incompatible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	139	139
No Code Available	93	93
No Known Impact Or Consequence To Patient	86	86
Dysphagia/ Odynophagia	70	70
No Clinical Signs, Symptoms or Conditions	58	58
No Consequences Or Impact To Patient	56	56
Non-union Bone Fracture	51	51
Neck Pain	49	49
Failure of Implant	37	37
Nerve Damage	34	34
Inadequate Pain Relief	26	26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
Numbness	22	22
Hematoma	18	18
Unspecified Infection	17	17
Cerebrospinal Fluid Leakage	16	16
Insufficient Information	16	16
No Information	13	13
Physical Asymmetry	12	12
Bone Fracture(s)	12	12
Post Operative Wound Infection	12	12
Unspecified Tissue Injury	10	10
Osteolysis	10	10
Fatigue	9	9
Muscle Weakness	9	9
Weakness	8	8
Impaired Healing	7	7
Calcium Deposits/Calcification	7	7
Muscular Rigidity	7	7
Injury	7	7
Paralysis	7	7
Vertebral Fracture	6	6
Intervertebral Disc Compression or Protrusion	6	6
Stenosis	6	6
Discomfort	6	6
Loss of Range of Motion	6	6
Patient Problem/Medical Problem	6	6
Joint Disorder	5	5
Hypersensitivity/Allergic reaction	5	5
Dyspnea	5	5
Foreign Body In Patient	5	5
Device Embedded In Tissue or Plaque	4	4
Ambulation Difficulties	4	4
Reaction	4	4
Quadriplegia	4	4
Spinal Cord Injury	4	4
Implant Pain	4	4
Swelling	4	4
Decreased Sensitivity	3	3
Tingling	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Exactech, Inc.	II	Jul-31-2012
2	Medicrea International	II	Aug-24-2023
3	RTI Surgical, Inc.	II	Jan-03-2014
4	SpineNet	II	Aug-27-2013
5	Synthes Spine	II	Jun-10-2009
6	Synthes USA (HQ), Inc.	II	Oct-21-2011
7	XTANT Medical	III	Nov-06-2020