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
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	1
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
BIOGEND THERAPEUTICS CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
CAMBER SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
CAMBER SPINE TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
CARBOFIX ORTHOPEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARBOFIX ORTHPEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARLSMED, INC.
	SUBSTANTIALLY EQUIVALENT	5
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
	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
CORELINK, LLC
	SUBSTANTIALLY EQUIVALENT	1
CTL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
CURITEVA, INC.
	SUBSTANTIALLY EQUIVALENT	1
CUTTING EDGE SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	3
DEGEN MEDICAL
	SUBSTANTIALLY EQUIVALENT	4
DIFUSION TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
EIT EMERGING IMPLANT TECHNOLOGIES GMBH
	SUBSTANTIALLY EQUIVALENT	2
EMINENT SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
ENZTEC LIMITED
	SUBSTANTIALLY EQUIVALENT	4
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	2
GENESYS SPINE
	SUBSTANTIALLY EQUIVALENT	2
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	4
GS MEDICAL CO. LTD.
	SUBSTANTIALLY EQUIVALENT	2
ICOTEC AG
	SUBSTANTIALLY EQUIVALENT	1
INNOVASIS, INC.
	SUBSTANTIALLY EQUIVALENT	3
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	1
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
LIFE SPINE INC.
	SUBSTANTIALLY EQUIVALENT	7
LIFE SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	7
MEDACTA INERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S .A.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	4
MEDOS INTERNATIONAL SÀRL
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL, SARL
	SUBSTANTIALLY EQUIVALENT	3
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
NANOHIVE MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
NEO MEDICAL S.A.
	SUBSTANTIALLY EQUIVALENT	2
NEUROSTRUCTURES, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEXUS SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
NEXXT SPINE LLC
	SUBSTANTIALLY EQUIVALENT	4
NGMEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	10
NVISION BIOMEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
OC MEDICAL DEVICES
	SUBSTANTIALLY EQUIVALENT	1
OMNIA MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
ORTHOFIX INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX US 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
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 LLC
	SUBSTANTIALLY EQUIVALENT	1
REPUBLIC SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
RESTOR3D
	SUBSTANTIALLY EQUIVALENT	2
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	13
SHANGHAI REACH MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI SANYOU MEDICAL CO, LTD
	SUBSTANTIALLY EQUIVALENT	2
SIGNUS MEDIZINTECHNIK
	SUBSTANTIALLY EQUIVALENT	1
SILONY MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
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
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ELEMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	4
SPINAL STABILITY, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINE WAVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINEEX INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINEEX, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINEFRONTIER, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINEOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	2
SPINEVISION SAS
	SUBSTANTIALLY EQUIVALENT	1
SPINEVISION, S.A.S.
	SUBSTANTIALLY EQUIVALENT	1
SPINEWORXX AG
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
STRYKER SPINE
	SUBSTANTIALLY EQUIVALENT	1
TDM CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
TRANS1
	SUBSTANTIALLY EQUIVALENT	1
U&I CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VY SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
WENZEL SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
XENCO MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
ZAVATION MEDICAL PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	3
ZAVATION MEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	4
ZS FAB INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	699	699
2020	640	640
2021	621	621
2022	617	622
2023	578	578
2024	277	277

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	850	850
Migration	509	509
Adverse Event Without Identified Device or Use Problem	463	463
Device-Device Incompatibility	295	295
Fracture	263	267
Compatibility Problem	132	132
Mechanical Problem	112	112
Material Integrity Problem	102	102
Insufficient Information	87	87
Migration or Expulsion of Device	80	80
Material Deformation	79	80
Mechanical Jam	59	59
Detachment of Device or Device Component	56	56
Collapse	56	56
Appropriate Term/Code Not Available	55	55
Mechanics Altered	50	50
Patient Device Interaction Problem	46	46
Material Twisted/Bent	37	37
Use of Device Problem	37	37
Device Dislodged or Dislocated	35	35
Material Fragmentation	35	35
No Apparent Adverse Event	26	26
Malposition of Device	24	24
Physical Resistance/Sticking	23	23
Crack	21	21
Improper or Incorrect Procedure or Method	20	20
Loosening of Implant Not Related to Bone-Ingrowth	20	20
Difficult to Insert	17	18
Unintended Movement	14	14
Device Handling Problem	13	13
Entrapment of Device	12	12
Device Slipped	11	11
Device Sensing Problem	11	11
Material Separation	10	10
Positioning Problem	10	10
Difficult to Advance	8	8
Expulsion	8	8
Device Damaged by Another Device	7	7
Inadequacy of Device Shape and/or Size	7	7
Difficult to Remove	6	6
Imprecision	6	6
Failure to Eject	6	6
Inaccurate Information	6	6
Material Split, Cut or Torn	5	5
Osseointegration Problem	5	5
Difficult or Delayed Positioning	5	5
Product Quality Problem	5	5
Loose or Intermittent Connection	5	5
Biocompatibility	5	5
Contamination /Decontamination Problem	4	4
Unstable	4	4
Human-Device Interface Problem	4	4
Naturally Worn	3	3
Device Markings/Labelling Problem	3	3
Patient-Device Incompatibility	3	3
Failure to Osseointegrate	3	3
Unintended System Motion	3	3
Off-Label Use	3	3
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Output Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Device Difficult to Maintain	3	3
Activation Failure	2	2
Separation Problem	2	2
Device Damaged Prior to Use	2	2
Defective Component	2	2
Microbial Contamination of Device	2	2
Solder Joint Fracture	2	2
Material Erosion	2	2
Misassembled	2	2
Failure to Advance	2	2
Failure to Disconnect	2	2
Separation Failure	2	2
Activation, Positioning or Separation Problem	2	2
Installation-Related Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Difficult to Open or Close	2	2
Inadequate User Interface	1	1
Material Protrusion/Extrusion	1	1
Connection Problem	1	1
Deformation Due to Compressive Stress	1	1
Defective Device	1	1
Device Tipped Over	1	1
Nonstandard Device	1	1
Labelling, Instructions for Use or Training Problem	1	1
Positioning Failure	1	1
Disconnection	1	1
Degraded	1	1
Use of Incorrect Control/Treatment Settings	1	1
Dull, Blunt	1	1
Loss of Osseointegration	1	1
Unexpected Therapeutic Results	1	1
Device Appears to Trigger Rejection	1	1
Partial Blockage	1	1
Premature Separation	1	1
Ejection Problem	1	1
Activation Problem	1	1
Misassembly by Users	1	1
Packaging Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1320	1325
No Known Impact Or Consequence To Patient	430	430
Pain	320	320
No Consequences Or Impact To Patient	230	230
Insufficient Information	225	225
No Code Available	210	210
Failure of Implant	131	131
Unspecified Infection	100	100
Device Embedded In Tissue or Plaque	82	82
Foreign Body In Patient	80	80
Nerve Damage	65	65
Non-union Bone Fracture	61	61
Unspecified Tissue Injury	60	60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	57	57
Hematoma	53	53
Osteolysis	50	50
Injury	47	47
Post Operative Wound Infection	42	42
Joint Laxity	35	35
Bone Fracture(s)	32	32
No Patient Involvement	30	30
Neuropathy	25	25
No Information	24	24
Hemorrhage/Bleeding	21	21
Cerebrospinal Fluid Leakage	20	20
Laceration(s)	18	18
Perforation of Vessels	17	17
Unspecified Nervous System Problem	17	17
Spinal Cord Injury	17	17
Numbness	15	15
Tissue Damage	15	15
Stenosis	14	14
Vertebral Fracture	13	13
Weakness	13	13
Unspecified Musculoskeletal problem	12	12
Patient Problem/Medical Problem	12	12
Hypersensitivity/Allergic reaction	11	11
Fall	11	11
Arthritis	11	11
Wound Dehiscence	10	10
Dysphagia/ Odynophagia	10	10
Paralysis	9	9
Spinal Column Injury	9	9
Discomfort	9	9
Impaired Healing	9	9
Inadequate Osseointegration	9	9
Headache	8	8
Cyst(s)	8	8
Neck Pain	7	7
Excessive Tear Production	7	7
Hypoesthesia	6	6
Decreased Sensitivity	6	6
Implant Pain	6	6
Intervertebral Disc Compression or Protrusion	6	6
Sepsis	6	6
Damage to Ligament(s)	6	6
Inflammation	5	5
Muscle Weakness	5	5
Neurological Deficit/Dysfunction	5	5
Seroma	5	5
Swelling	5	5
Cardiac Arrest	5	5
Pulmonary Embolism	5	5
Abscess	5	5
Aspiration/Inhalation	5	5
Incontinence	5	5
Speech Disorder	5	5
Blood Loss	5	5
Depression	4	4
Urinary Tract Infection	4	4
Hernia	4	4
Ambulation Difficulties	4	4
Thrombosis/Thrombus	4	4
Pneumonia	4	4
Undesired Nerve Stimulation	4	4
Itching Sensation	3	3
Muscle Spasm(s)	3	3
Perforation	3	3
Loss of Range of Motion	3	3
Rash	3	3
Fever	3	3
Bacterial Infection	3	3
Bowel Perforation	3	3
Paresthesia	3	3
Nervous System Injury	3	3
Rupture	3	3
Tingling	3	3
Osteopenia/ Osteoporosis	3	3
Thromboembolism	3	3
Swelling/ Edema	3	3
Disc Impingement	2	2
Joint Disorder	2	2
Unspecified Vascular Problem	2	2
Cramp(s) /Muscle Spasm(s)	2	2
Malunion of Bone	2	2
Anemia	2	2
Abdominal Pain	2	2
Bruise/Contusion	2	2
Death	2	2
Fatigue	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 Spine, Inc.	II	Jul-01-2022
4	DePuy Spine, Inc.	II	Apr-27-2019
5	Globus Medical, Inc.	II	Aug-22-2020
6	K2M, Inc	II	Jun-01-2021
7	Medicrea International	II	Aug-24-2023
8	Medicrea International	II	Feb-12-2020
9	Medtronic Sofamor Danek USA, Inc	II	Apr-20-2021
10	SPINEART SA	III	Nov-22-2019
11	Stryker Spine	II	Apr-20-2021
12	XTANT MEDICAL INC	II	Jan-30-2019