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
ACUITY SURGICAL DEVICES, LLC
	SUBSTANTIALLY EQUIVALENT	1
ADCURA, INC.
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED RESEARCH MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
AEGIS SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
ALPHATEC SPINE
	SUBSTANTIALLY EQUIVALENT	1
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	10
ALTUS PARTNERS, LLC
	SUBSTANTIALLY EQUIVALENT	1
AMPLIFY SURGICAL INC
	SUBSTANTIALLY EQUIVALENT	1
AMPLIFY SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
ASTURA MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
ASTURA MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	3
BAAT MEDICAL PRODUCTS BV
	SUBSTANTIALLY EQUIVALENT	1
BAUI BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BENVENUE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
BIOGENNIX, LLC
	SUBSTANTIALLY EQUIVALENT	1
CAMBER SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
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	4
CENTINEL SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
CHOICE SPINE, LP.
	SUBSTANTIALLY EQUIVALENT	1
CHOICESPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
CHOICESPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
CLARIANCE
	SUBSTANTIALLY EQUIVALENT	1
CLARIANCE SAS
	SUBSTANTIALLY EQUIVALENT	1
CLARIANCE, SAS
	SUBSTANTIALLY EQUIVALENT	1
COLIGNE, AG
	SUBSTANTIALLY EQUIVALENT	1
CORELINK, LLC
	SUBSTANTIALLY EQUIVALENT	2
CTL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
CURITEVA, LLC
	SUBSTANTIALLY EQUIVALENT	1
CUTTING EDGE SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	4
DEGEN MEDICAL
	SUBSTANTIALLY EQUIVALENT	3
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	3
EMINENT SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
ENZTEC LIMITED
	SUBSTANTIALLY EQUIVALENT	3
EXPANDING INNOVATIONS, INC
	SUBSTANTIALLY EQUIVALENT	3
EXPANDING INNOVATIONS, INC.
	SUBSTANTIALLY EQUIVALENT	2
FIMS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FLOSPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
GBS COMMONWEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GENESYS SPINE
	SUBSTANTIALLY EQUIVALENT	2
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	4
GS MEDICAL CO. LTD.
	SUBSTANTIALLY EQUIVALENT	2
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, INC.
	SUBSTANTIALLY EQUIVALENT	2
KALITEC MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
KEOS
	SUBSTANTIALLY EQUIVALENT	1
KUROS BIOSCIENCES BV
	SUBSTANTIALLY EQUIVALENT	1
KYOCERA MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
L&K BIOMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
LEGEND SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
LIFE SPINE
	SUBSTANTIALLY EQUIVALENT	1
LIFE SPINE INC.
	SUBSTANTIALLY EQUIVALENT	9
LIFE SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	6
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	5
MEDOS INTERNATIONAL SÀRL
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL, SARL
	SUBSTANTIALLY EQUIVALENT	4
MEDTRONIC SOFAMOR DANEK
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA, INC
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	5
MEDTRONIC SOFAMOR DANEK, USA INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDYSSEY USA, INC.
	SUBSTANTIALLY EQUIVALENT	3
MET ONE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
MET ONE TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
MIRUS, LLC
	SUBSTANTIALLY EQUIVALENT	3
NANOVIS LLC
	SUBSTANTIALLY EQUIVALENT	1
NEO MEDICAL S.A.
	SUBSTANTIALLY EQUIVALENT	2
NEUROSTRUCTURES, INC.
	SUBSTANTIALLY EQUIVALENT	2
NEXUS SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
NEXXT SPINE LLC
	SUBSTANTIALLY EQUIVALENT	4
NGMEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	13
NVISION BIOMEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
OC MEDICAL DEVICES
	SUBSTANTIALLY EQUIVALENT	1
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
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	1
PRECISION SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
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	1
REPUBLIC SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
RESTOR3D
	SUBSTANTIALLY EQUIVALENT	1
RUBICON SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	13
SHANGHAI SANYOU MEDICAL CO, LTD
	SUBSTANTIALLY EQUIVALENT	1
SIGNUS MEDIZINTECHNIK
	SUBSTANTIALLY EQUIVALENT	1
SILONY MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	3
SOLCO BIOMEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SOUTHERN MEDICAL (PTY) LTD
	SUBSTANTIALLY EQUIVALENT	1
SOUTHERN SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
SPECTRUM SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
SPINAL ELEMENTS INC
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ELEMENTS INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ELEMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	3
SPINAL STABILITY, LLC
	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	3
SPINEVISION SAS
	SUBSTANTIALLY EQUIVALENT	1
SPINEVISION, S.A.S.
	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
TDM CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
TRANS1
	SUBSTANTIALLY EQUIVALENT	1
U&I CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
VALLUM CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VY SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
WENZEL SPINE, 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	5
ZIMMER BIOMET SPINE INC.
	SUBSTANTIALLY EQUIVALENT	1
ZS FAB INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	614	614
2019	699	699
2020	640	640
2021	621	621
2022	619	624
2023	212	212

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1020	1020
Migration	458	458
Adverse Event Without Identified Device or Use Problem	423	423
Fracture	262	266
Device-Device Incompatibility	260	260
Migration or Expulsion of Device	139	139
Material Integrity Problem	105	105
Compatibility Problem	101	101
Material Deformation	73	74
Mechanical Jam	68	68
Detachment of Device or Device Component	58	58
Mechanical Problem	57	57
Collapse	57	57
Insufficient Information	55	55
Appropriate Term/Code Not Available	55	55
Device Dislodged or Dislocated	47	47
Material Fragmentation	40	40
Malposition of Device	33	33
Use of Device Problem	31	31
Material Twisted/Bent	31	31
Patient Device Interaction Problem	30	30
Mechanics Altered	30	30
Crack	27	27
No Apparent Adverse Event	25	25
Physical Resistance/Sticking	25	25
Difficult to Insert	24	25
Device Operates Differently Than Expected	23	23
Improper or Incorrect Procedure or Method	21	21
Unintended Movement	21	21
Loosening of Implant Not Related to Bone-Ingrowth	19	19
Device Handling Problem	14	14
Device Slipped	12	12
Loose or Intermittent Connection	11	11
Difficult to Remove	11	11
Positioning Problem	10	10
Device Sensing Problem	9	9
Inadequacy of Device Shape and/or Size	9	9
Patient-Device Incompatibility	8	8
Material Separation	8	8
Detachment Of Device Component	8	8
Difficult to Advance	8	8
Expulsion	7	7
Material Disintegration	7	7
Biocompatibility	6	6
Device Damaged by Another Device	6	6
Failure to Eject	6	6
Inaccurate Information	5	5
Material Split, Cut or Torn	5	5
Device Operational Issue	5	5
Activation, Positioning or Separation Problem	5	5
Entrapment of Device	5	5
Imprecision	5	5
Disassembly	5	5
Difficult or Delayed Positioning	4	4
Off-Label Use	4	4
Device Markings/Labelling Problem	4	4
Unstable	4	4
Osseointegration Problem	4	4
Output Problem	3	3
Material Protrusion/Extrusion	3	3
Installation-Related Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Naturally Worn	3	3
Device Difficult to Maintain	3	3
Fitting Problem	3	3
Defective Component	3	3
Failure to Osseointegrate	3	3
Contamination /Decontamination Problem	3	3
Defective Device	3	3
Product Quality Problem	3	3
Nonstandard Device	3	3
Unintended System Motion	2	2
Labelling, Instructions for Use or Training Problem	2	2
Misassembled	2	2
Positioning Failure	2	2
Disconnection	2	2
Material Erosion	2	2
Component Falling	2	2
Degraded	2	2
Bent	2	2
Failure to Disconnect	2	2
Separation Failure	2	2
Device Damaged Prior to Use	2	2
Solder Joint Fracture	2	2
Device Issue	2	2
Loss of Osseointegration	2	2
Failure to Advance	2	2
Sticking	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Difficult to Open or Close	2	2
Device Fell	2	2
Separation Problem	2	2
Premature Separation	1	1
Inadequate User Interface	1	1
Material Torqued	1	1
Packaging Problem	1	1
Physical Property Issue	1	1
Misassembly by Users	1	1
Torn Material	1	1
Ejection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1009	1014
No Known Impact Or Consequence To Patient	696	696
Pain	330	330
No Consequences Or Impact To Patient	319	319
No Code Available	290	290
Failure of Implant	142	142
Insufficient Information	102	102
Device Embedded In Tissue or Plaque	91	91
Unspecified Infection	79	79
Injury	78	78
Foreign Body In Patient	77	77
No Patient Involvement	46	46
Hematoma	45	45
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	44	44
No Information	43	43
Unspecified Tissue Injury	42	42
Non-union Bone Fracture	39	39
Nerve Damage	39	39
Post Operative Wound Infection	32	32
Bone Fracture(s)	31	31
Neuropathy	23	23
Cerebrospinal Fluid Leakage	22	22
Osteolysis	22	22
Hemorrhage/Bleeding	18	18
Numbness	17	17
Tissue Damage	17	17
Laceration(s)	17	17
Patient Problem/Medical Problem	16	16
Weakness	15	15
Perforation of Vessels	14	14
Not Applicable	14	14
Unspecified Nervous System Problem	13	13
Wound Dehiscence	13	13
Spinal Cord Injury	12	12
Spinal Column Injury	11	11
Stenosis	11	11
Vertebral Fracture	11	11
Blood Loss	11	11
Fall	11	11
Unspecified Musculoskeletal problem	10	10
Neurological Deficit/Dysfunction	9	9
Paralysis	9	9
Headache	8	8
Hypersensitivity/Allergic reaction	8	8
Damage to Ligament(s)	8	8
Inadequate Osseointegration	8	8
Sepsis	7	7
Excessive Tear Production	7	7
Cyst(s)	7	7
Discomfort	7	7
Dysphagia/ Odynophagia	7	7
Perforation	6	6
Hypoesthesia	6	6
Aspiration/Inhalation	6	6
Swelling	6	6
Inflammation	5	5
Death	5	5
Incontinence	5	5
Neck Pain	5	5
Decreased Sensitivity	5	5
Cardiac Arrest	5	5
Depression	4	4
Pneumonia	4	4
Ambulation Difficulties	4	4
Intervertebral Disc Compression or Protrusion	4	4
Urinary Tract Infection	4	4
Joint Laxity	4	4
Impaired Healing	4	4
Abdominal Pain	4	4
Bowel Perforation	4	4
Muscle Spasm(s)	3	3
Loss of Range of Motion	3	3
Pulmonary Embolism	3	3
Arthritis	3	3
Disc Impingement	3	3
Nervous System Injury	3	3
Implant Pain	3	3
Muscle Weakness	3	3
Anemia	3	3
Tingling	3	3
Inadequate Pain Relief	3	3
Fever	3	3
Osteopenia/ Osteoporosis	3	3
Rash	3	3
Rupture	3	3
Hernia	3	3
Abscess	3	3
Paraplegia	3	3
Itching Sensation	3	3
Undesired Nerve Stimulation	2	2
Encephalopathy	2	2
Unspecified Vascular Problem	2	2
Joint Disorder	2	2
Bruise/Contusion	2	2
Low Blood Pressure/ Hypotension	2	2
Fatigue	2	2
Paresthesia	2	2
Fibrosis	2	2
Hemostasis	2	2
Burning Sensation	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	CTL Medical Corporation	II	Jul-04-2020
2	CoreLink LLC	II	Jan-12-2023
3	DePuy Orthopaedics, Inc.	II	Mar-02-2018
4	DePuy Spine, Inc.	II	Jul-01-2022
5	DePuy Spine, Inc.	II	Apr-27-2019
6	Globus Medical, Inc.	II	Aug-22-2020
7	Howmedica Osteonics Corp.	II	Dec-13-2018
8	Integrity Implants Inc.	II	Nov-07-2018
9	K2M, Inc	II	Jun-01-2021
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