TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
4WEB MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
4WEB, INC.
	SUBSTANTIALLY EQUIVALENT	3
ADVANCED RESEARCH MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
AEGIS SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	7
ALTUS PARTNERS, LLC
	SUBSTANTIALLY EQUIVALENT	5
AMPLIFY SURGICAL INC
	SUBSTANTIALLY EQUIVALENT	1
AMPLIFY SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ASTURA MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
ASTURA MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	3
ATLAS SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
BAAT MEDICAL PRODUCTS BV
	SUBSTANTIALLY EQUIVALENT	1
BAUI BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BENVENUE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
BIEDERMANN MOTECH GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
BIOGENNIX, LLC
	SUBSTANTIALLY EQUIVALENT	1
BLUESTONE SYNERGY
	SUBSTANTIALLY EQUIVALENT	1
CAMBER SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	3
CAMBER SPINE TECHNOLOGIES LLC
	SUBSTANTIALLY EQUIVALENT	1
CAMBER SPINE TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
CAPTIVA SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARBOFIX ORTHOPEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARBOFIX ORTHPEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARLSMED, INC.
	SUBSTANTIALLY EQUIVALENT	2
CENTINEL SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
CHOICE SPINE, LP.
	SUBSTANTIALLY EQUIVALENT	1
CHOICESPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
CLARIANCE
	SUBSTANTIALLY EQUIVALENT	1
CLARIANCE SAS
	SUBSTANTIALLY EQUIVALENT	1
CLARIANCE, SAS
	SUBSTANTIALLY EQUIVALENT	2
COLIGNE, AG
	SUBSTANTIALLY EQUIVALENT	1
CORELINK, LLC
	SUBSTANTIALLY EQUIVALENT	2
CORENTEC CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
CTL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CURITEVA, LLC
	SUBSTANTIALLY EQUIVALENT	1
CUTTING EDGE SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	4
DEGEN MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
DEPUY SYNTHES SPINE
	SUBSTANTIALLY EQUIVALENT	1
DIFUSION TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
DOUBLE MEDICAL TECHNOLOGY INC
	SUBSTANTIALLY EQUIVALENT	1
EIT EMERGING IMPLANT TECHNOLOGIES GMBH
	SUBSTANTIALLY EQUIVALENT	5
ENZTEC LIMITED
	SUBSTANTIALLY EQUIVALENT	1
EXPANDING INNOVATIONS, INC
	SUBSTANTIALLY EQUIVALENT	2
EXPANDING INNOVATIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
EXPANDING ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
FACETLINK DBA LINKSPINE
	SUBSTANTIALLY EQUIVALENT	1
FIMS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FLOSPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
GBS COMMONWEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GENESYS SPINE
	SUBSTANTIALLY EQUIVALENT	3
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	6
HD LIFESCIENCES LLC
	SUBSTANTIALLY EQUIVALENT	1
HT MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
HUVEXEL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
INNOVASIS, INC.
	SUBSTANTIALLY EQUIVALENT	4
INNOVASIVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTEGRITY IMPLANTS INC
	SUBSTANTIALLY EQUIVALENT	3
INTEGRITY IMPLANTS INC.
	SUBSTANTIALLY EQUIVALENT	4
INTELIVATION LLC
	SUBSTANTIALLY EQUIVALENT	1
JOIMAX GMBH
	SUBSTANTIALLY EQUIVALENT	1
K2M
	SUBSTANTIALLY EQUIVALENT	1
K2M, INC.
	SUBSTANTIALLY EQUIVALENT	4
KALITEC MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
KEOS
	SUBSTANTIALLY EQUIVALENT	2
KUROS BIOSCIENCES BV
	SUBSTANTIALLY EQUIVALENT	1
KYOCERA MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
L&K BIOMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
LEGEND SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
LIFE SPINE
	SUBSTANTIALLY EQUIVALENT	1
LIFE SPINE INC.
	SUBSTANTIALLY EQUIVALENT	10
LIFE SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	4
MEDACTA INERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S .A.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	2
MEDICAL DESIGNS, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	6
MEDITECH SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL, SARL
	SUBSTANTIALLY EQUIVALENT	4
MEDTRONIC SOFAMOR DANEK
	SUBSTANTIALLY EQUIVALENT	4
MEDTRONIC SOFAMOR DANEK USA
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA, INC
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	7
MEDTRONIC SOFAMOR DANEK, USA INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDYSSEY USA, INC.
	SUBSTANTIALLY EQUIVALENT	5
MET ONE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
MIRUS, LLC
	SUBSTANTIALLY EQUIVALENT	3
NANOVIS LLC
	SUBSTANTIALLY EQUIVALENT	1
NEO MEDICAL S.A.
	SUBSTANTIALLY EQUIVALENT	2
NEUROSTRUCTURES, INC.
	SUBSTANTIALLY EQUIVALENT	3
NEXUS SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	3
NEXXT SPINE LLC
	SUBSTANTIALLY EQUIVALENT	4
NGMEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
NUVASIVE INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	18
NVISION BIOMEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
OMNIA MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
ORTHOFIX INC.
	SUBSTANTIALLY EQUIVALENT	2
ORTHOFIX US LLC
	SUBSTANTIALLY EQUIVALENT	1
OSSEUS FUSION SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
PANTHEON SPINAL
	SUBSTANTIALLY EQUIVALENT	2
PAONAN BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
PARADIGM SPINE, GMBH
	SUBSTANTIALLY EQUIVALENT	1
PINNACLE SPINE GROUP, LLC
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY, INC. DBA RTI SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY, INC., DBA RTI SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PRECIFIT MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	2
PRECISION SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
PRINTERPREZZ
	SUBSTANTIALLY EQUIVALENT	1
PRISM SURGICAL DESIGNS PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
RAED M. ALI, M.D., INC.
	SUBSTANTIALLY EQUIVALENT	1
RAED M. ALI, MD., INC.
	SUBSTANTIALLY EQUIVALENT	1
RELIANCE MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
RELIANCE MEDICAL SYSTEMS LLC
	SUBSTANTIALLY EQUIVALENT	1
RELIANCE MEDICAL SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
RENOVIS SURGICAL TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
REPUBLIC SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
RTI SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
RTI SURGICAL, INC. DBA RTI BIOLOGICS
	SUBSTANTIALLY EQUIVALENT	1
RUBICON SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	14
SHANGHAI SANYOU MEDICAL CO, LTD
	SUBSTANTIALLY EQUIVALENT	1
SIGNATURE ORTHOPAEDICS PTY LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIGNUS MEDIZINTECHNIK
	SUBSTANTIALLY EQUIVALENT	1
SILONY MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	4
SOLCO BIOMEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SOUTHERN SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
SPECTRUM SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
SPINAL ANALYTICS & GEOMETRICAL IMPANT CO, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ELEMENTS INC
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ELEMENTS INC.
	SUBSTANTIALLY EQUIVALENT	2
SPINAL ELEMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	3
SPINAL STABILITY, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINE WAVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINEART
	SUBSTANTIALLY EQUIVALENT	2
SPINEEX INC.
	SUBSTANTIALLY EQUIVALENT	2
SPINEEX, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINEFRONTIER, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINEMED GES.M.B.H
	SUBSTANTIALLY EQUIVALENT	1
SPINEOLOGY INC
	SUBSTANTIALLY EQUIVALENT	1
SPINEOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	7
SPINEVISION SAS
	SUBSTANTIALLY EQUIVALENT	1
SPINEVISION, SAS
	SUBSTANTIALLY EQUIVALENT	1
SPINEWORXX AG
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
STRYKER SPINE
	SUBSTANTIALLY EQUIVALENT	2
SUMMIT SPINE
	SUBSTANTIALLY EQUIVALENT	1
TITAN SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
TRANS1
	SUBSTANTIALLY EQUIVALENT	1
U&I CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
VALLUM CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VERTERA, INC.
	SUBSTANTIALLY EQUIVALENT	1
VY SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
WENZEL SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
X-SPINE SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
XENCO MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
XENCO MEDICAL, LLC.
	SUBSTANTIALLY EQUIVALENT	1
ZAVATION MEDICAL PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	3
ZAVATION MEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	4
ZAVATION, LLC
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER BIOMET SPINE INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2017	595	595
2018	614	614
2019	699	699
2020	640	640
2021	621	621
2022	250	250

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1094	1094
Adverse Event Without Identified Device or Use Problem	474	474
Migration	362	362
Fracture	247	247
Migration or Expulsion of Device	225	225
Device-Device Incompatibility	200	200
Material Integrity Problem	105	105
Compatibility Problem	88	88
Mechanical Jam	87	87
Material Deformation	66	66
Mechanical Problem	64	64
Collapse	62	62
Appropriate Term/Code Not Available	53	53
Device Dislodged or Dislocated	52	52
Detachment of Device or Device Component	51	51
Device Operates Differently Than Expected	50	50
Insufficient Information	49	49
Material Fragmentation	48	48
Malposition of Device	43	43
Unintended Movement	41	41
Crack	33	33
Material Twisted/Bent	30	30
Difficult to Insert	25	25
Physical Resistance/Sticking	24	24
Use of Device Problem	23	23
No Apparent Adverse Event	22	22
Mechanics Altered	22	22
Improper or Incorrect Procedure or Method	21	21
Detachment Of Device Component	20	20
Patient Device Interaction Problem	20	20
Loosening of Implant Not Related to Bone-Ingrowth	17	17
Positioning Problem	16	16
Loose or Intermittent Connection	16	16
Device Slipped	16	16
Device Handling Problem	15	15
Difficult to Remove	12	12
Fitting Problem	11	11
Inadequacy of Device Shape and/or Size	9	9
Patient-Device Incompatibility	9	9
Separation Failure	9	9
Material Separation	8	8
Material Disintegration	8	8
Device Damaged by Another Device	7	7
Device Sensing Problem	6	6
Material Protrusion/Extrusion	6	6
Disassembly	6	6
Bent	6	6
Biocompatibility	6	6
Device Issue	5	5
Unstable	5	5
Failure to Osseointegrate	5	5
Difficult or Delayed Positioning	5	5
Positioning Failure	5	5
Activation, Positioning or SeparationProblem	5	5
Device Operational Issue	5	5
Device Markings/Labelling Problem	5	5
Difficult to Advance	4	4
Installation-Related Problem	4	4
Human Factors Issue	4	4
Inaccurate Information	4	4
Entrapment of Device	4	4
Material Erosion	4	4
Off-Label Use	4	4
Sticking	4	4
Failure to Align	4	4
Failure to Advance	3	3
Defective Device	3	3
Contamination /Decontamination Problem	3	3
Product Quality Problem	3	3
Nonstandard Device	3	3
Imprecision	3	3
Component Falling	3	3
Device Difficult to Maintain	3	3
Connection Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Osseointegration Problem	2	2
Output Problem	2	2
Packaging Problem	2	2
Naturally Worn	2	2
Failure to Disconnect	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Expulsion	2	2
Missing Value Reason	2	2
Material Split, Cut or Torn	2	2
Device Fell	2	2
Separation Problem	2	2
Disconnection	2	2
Labelling, Instructions for Use or Training Problem	2	2
Loss of Osseointegration	2	2
Component Missing	2	2
Device Damaged Prior to Use	2	2
Defective Component	1	1
Microbial Contamination of Device	1	1
Metal Shedding Debris	1	1
Unexpected Therapeutic Results	1	1
Problem with Sterilization	1	1
Retraction Problem	1	1
Solder Joint Fracture	1	1
Failure to Infuse	1	1
Split	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	977	977
No Clinical Signs, Symptoms or Conditions	616	616
No Code Available	373	373
No Consequences Or Impact To Patient	346	346
Pain	335	335
Failure of Implant	160	160
Injury	120	120
Device Embedded In Tissue or Plaque	93	93
No Information	83	83
Unspecified Infection	80	80
Insufficient Information	75	75
No Patient Involvement	70	70
Foreign Body In Patient	65	65
Hematoma	42	42
Nerve Damage	38	38
Unspecified Tissue Injury	36	36
Bone Fracture(s)	34	34
Non-union Bone Fracture	33	33
Post Operative Wound Infection	31	31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	29	29
Patient Problem/Medical Problem	22	22
Osteolysis	22	22
Numbness	22	22
Cerebrospinal Fluid Leakage	22	22
Neuropathy	22	22
Tissue Damage	18	18
Weakness	17	17
Neurological Deficit/Dysfunction	16	16
Hemorrhage/Bleeding	16	16
Blood Loss	15	15
Not Applicable	14	14
Spinal Column Injury	14	14
Perforation of Vessels	13	13
Damage to Ligament(s)	13	13
Stenosis	12	12
Vertebral Fracture	11	11
Discomfort	9	9
Paralysis	9	9
Wound Dehiscence	9	9
Hypersensitivity/Allergic reaction	8	8
Death	8	8
Dysphagia/ Odynophagia	8	8
Fall	8	8
Headache	8	8
Excessive Tear Production	8	8
Inadequate Osseointegration	8	8
Spinal Cord Injury	7	7
Laceration(s)	7	7
Inflammation	7	7
Swelling	7	7
Cyst(s)	7	7
Aspiration/Inhalation	6	6
Inadequate Pain Relief	6	6
Hypoesthesia	6	6
Unspecified Nervous System Problem	6	6
Bowel Perforation	5	5
Decreased Sensitivity	5	5
Ambulation Difficulties	5	5
Neck Pain	5	5
Impaired Healing	5	5
Abdominal Pain	5	5
Fever	5	5
Incontinence	5	5
Perforation	4	4
Pneumonia	4	4
Sepsis	4	4
Cardiac Arrest	4	4
Urinary Tract Infection	4	4
Depression	4	4
Tingling	4	4
Paraplegia	4	4
Disc Impingement	4	4
Joint Laxity	4	4
Rupture	3	3
Disability	3	3
Joint Disorder	3	3
Reaction	3	3
Pulmonary Embolism	3	3
Abscess	3	3
Anemia	3	3
Urinary Retention	3	3
Itching Sensation	3	3
Muscle Spasm(s)	3	3
Muscle Weakness	3	3
Intervertebral Disc Compression or Protrusion	3	3
Implant Pain	3	3
Loss of Range of Motion	2	2
Rash	2	2
Thrombosis	2	2
Paresis	2	2
Undesired Nerve Stimulation	2	2
Arthritis	2	2
Bruise/Contusion	2	2
Low Blood Pressure/ Hypotension	2	2
Hemostasis	2	2
Fatigue	2	2
Encephalopathy	2	2
Hernia	2	2
Burning Sensation	2	2
Malunion of Bone	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	CTL Medical Corporation	II	Jul-04-2020
2	DePuy Orthopaedics, Inc.	II	Mar-02-2018
3	DePuy Spine, Inc.	II	Apr-27-2019
4	Globus Medical, Inc.	II	Aug-22-2020
5	Howmedica Osteonics Corp.	II	Dec-13-2018
6	Integrity Implants Inc.	II	Nov-07-2018
7	Interventional Spine Inc	II	Jan-03-2017
8	K2M, Inc	II	Jun-01-2021
9	Kiscomedica S.A.	II	Feb-27-2017
10	Medicrea International	II	Feb-12-2020
11	Medtronic Sofamor Danek USA, Inc	II	Apr-20-2021
12	Neuropro Spinal Jaxx	II	Apr-10-2018
13	SPINEART SA	III	Nov-22-2019
14	Spinal Elements	II	May-23-2018
15	Stryker Spine	II	Apr-20-2021
16	Stryker Spine	II	Oct-10-2018
17	XTANT MEDICAL INC	II	Jan-30-2019
18	Zimmer Biomet Spine, Inc	II	Mar-28-2017
19	Zimmer Trabecular Metal Technology, Inc.	III	May-10-2017