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	2
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	3
CAMBER SPINE TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
CARBOFIX ORTHOPEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARBOFIX ORTHPEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARLSMED
	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 MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX US LLC
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX, INC.
	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	15
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	618	623
2023	578	578
2024	371	371

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	858	858
Migration	516	516
Adverse Event Without Identified Device or Use Problem	470	470
Device-Device Incompatibility	303	303
Fracture	275	279
Compatibility Problem	134	134
Mechanical Problem	125	125
Material Integrity Problem	106	106
Insufficient Information	94	94
Migration or Expulsion of Device	87	87
Material Deformation	81	82
Mechanical Jam	60	60
Collapse	59	59
Detachment of Device or Device Component	57	57
Appropriate Term/Code Not Available	57	57
Mechanics Altered	51	51
Patient Device Interaction Problem	49	49
Material Twisted/Bent	41	41
Use of Device Problem	39	39
Device Dislodged or Dislocated	36	36
Material Fragmentation	35	35
No Apparent Adverse Event	26	26
Malposition of Device	24	24
Physical Resistance/Sticking	23	23
Crack	22	22
Improper or Incorrect Procedure or Method	20	20
Loosening of Implant Not Related to Bone-Ingrowth	20	20
Difficult to Insert	18	19
Device Handling Problem	15	15
Unintended Movement	14	14
Entrapment of Device	12	12
Device Slipped	11	11
Device Sensing Problem	11	11
Material Separation	10	10
Positioning Problem	10	10
Expulsion	8	8
Difficult to Advance	8	8
Device Damaged by Another Device	7	7
Inadequacy of Device Shape and/or Size	7	7
Difficult to Remove	6	6
Incorrect, Inadequate or Imprecise Result or Readings	6	6
Difficult or Delayed Positioning	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
Product Quality Problem	5	5
Loose or Intermittent Connection	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Biocompatibility	5	5
Contamination /Decontamination Problem	4	4
Unstable	4	4
Solder Joint Fracture	4	4
Human-Device Interface Problem	4	4
Off-Label Use	4	4
Unintended System Motion	3	3
Failure to Osseointegrate	3	3
Device Markings/Labelling Problem	3	3
Patient-Device Incompatibility	3	3
Output Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Naturally Worn	3	3
Device Difficult to Maintain	3	3
Activation Failure	2	2
Activation Problem	2	2
Separation Problem	2	2
Activation, Positioning or Separation Problem	2	2
Device Damaged Prior to Use	2	2
Defective Component	2	2
Microbial Contamination of Device	2	2
Failure to Advance	2	2
Failure to Disconnect	2	2
Separation Failure	2	2
Difficult to Open or Close	2	2
Installation-Related Problem	2	2
Misassembled	2	2
Material Erosion	2	2
Positioning Failure	1	1
Disconnection	1	1
Degraded	1	1
Use of Incorrect Control/Treatment Settings	1	1
Nonstandard Device	1	1
Labelling, Instructions for Use or Training Problem	1	1
Fitting Problem	1	1
Unexpected Therapeutic Results	1	1
Partial Blockage	1	1
Device Appears to Trigger Rejection	1	1
Material Protrusion/Extrusion	1	1
Inadequate User Interface	1	1
Defective Device	1	1
Device Tipped Over	1	1
Dull, Blunt	1	1
Loss of Osseointegration	1	1
Connection Problem	1	1
Deformation Due to Compressive Stress	1	1
Premature Separation	1	1
Ejection 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	1372	1377
No Known Impact Or Consequence To Patient	430	430
Pain	330	330
Insufficient Information	235	235
No Consequences Or Impact To Patient	230	230
No Code Available	210	210
Failure of Implant	132	132
Unspecified Infection	103	103
Device Embedded In Tissue or Plaque	83	83
Foreign Body In Patient	82	82
Nerve Damage	70	70
Non-union Bone Fracture	63	63
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	61	61
Unspecified Tissue Injury	60	60
Hematoma	55	55
Osteolysis	52	52
Injury	47	47
Post Operative Wound Infection	42	42
Joint Laxity	36	36
Bone Fracture(s)	34	34
No Patient Involvement	30	30
Neuropathy	25	25
No Information	24	24
Cerebrospinal Fluid Leakage	23	23
Hemorrhage/Bleeding	22	22
Laceration(s)	19	19
Spinal Cord Injury	19	19
Unspecified Nervous System Problem	18	18
Perforation of Vessels	18	18
Numbness	16	16
Vertebral Fracture	15	15
Tissue Damage	15	15
Stenosis	14	14
Weakness	13	13
Unspecified Musculoskeletal problem	13	13
Patient Problem/Medical Problem	12	12
Hypersensitivity/Allergic reaction	11	11
Dysphagia/ Odynophagia	11	11
Fall	11	11
Wound Dehiscence	11	11
Arthritis	11	11
Spinal Column Injury	10	10
Impaired Healing	10	10
Discomfort	9	9
Inadequate Osseointegration	9	9
Paralysis	9	9
Cyst(s)	8	8
Headache	8	8
Decreased Sensitivity	7	7
Excessive Tear Production	7	7
Neck Pain	7	7
Intervertebral Disc Compression or Protrusion	7	7
Ambulation Difficulties	6	6
Hypoesthesia	6	6
Implant Pain	6	6
Speech Disorder	6	6
Damage to Ligament(s)	6	6
Sepsis	6	6
Seroma	5	5
Swelling	5	5
Muscle Weakness	5	5
Inflammation	5	5
Incontinence	5	5
Neurological Deficit/Dysfunction	5	5
Aspiration/Inhalation	5	5
Pulmonary Embolism	5	5
Cardiac Arrest	5	5
Abscess	5	5
Blood Loss	5	5
Depression	4	4
Urinary Tract Infection	4	4
Hernia	4	4
Thrombosis/Thrombus	4	4
Undesired Nerve Stimulation	4	4
Pneumonia	4	4
Loss of Range of Motion	3	3
Rash	3	3
Perforation	3	3
Itching Sensation	3	3
Muscle Spasm(s)	3	3
Bacterial Infection	3	3
Fever	3	3
Paresthesia	3	3
Osteopenia/ Osteoporosis	3	3
Thromboembolism	3	3
Nervous System Injury	3	3
Bowel Perforation	3	3
Rupture	3	3
Tingling	3	3
Swelling/ Edema	3	3
Urinary Incontinence	2	2
Paraplegia	2	2
Joint Disorder	2	2
Disc Impingement	2	2
Movement Disorder	2	2
Unspecified Vascular Problem	2	2
Cramp(s) /Muscle Spasm(s)	2	2
Malunion of Bone	2	2
Foreign Body Reaction	2	2
Hemostasis	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Advanced Research Medical, LLC	II	Apr-29-2024
2	CTL Medical Corporation	II	Jul-04-2020
3	CoreLink LLC	II	Jan-12-2023
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	K2M, Inc	II	Jun-01-2021
8	Medicrea International	II	Aug-24-2023
9	Medicrea International	II	Feb-12-2020
10	Medtronic Sofamor Danek USA, Inc	II	Apr-20-2021
11	SPINEART SA	III	Nov-22-2019
12	Stryker Spine	II	Apr-20-2021
13	XTANT MEDICAL INC	II	Jan-30-2019