TPLC - Total Product Life Cycle

• Device: filler, bone void, calcium compound
• Product Code: MQV
• Regulation Number: 888.3045
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ACRO BIOMEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
AG DIGITAL TECHNOLOGY CORP.
	SUBSTANTIALLY EQUIVALENT	3
AGNOVOS HEALTHCARE USA, LLC
	SUBSTANTIALLY EQUIVALENT	2
ALLOSOURCE, INC.
	SUBSTANTIALLY EQUIVALENT	1
AMEND SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ANIKA THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
ANIKA THERAPEUTICS. INC.
	SUBSTANTIALLY EQUIVALENT	2
ARTOSS GMBH
	SUBSTANTIALLY EQUIVALENT	3
ATPAC MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
BACTERIN INTERNATIONAL INC.
	SUBSTANTIALLY EQUIVALENT	2
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	1
BAXTER HEALTHCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO, L
	SUBSTANTIALLY EQUIVALENT	1
BERKELEY ADVANCED BIOMATERIALS
	SUBSTANTIALLY EQUIVALENT	1
BERKELEY ADVANCED BIOMATERIALS, INC.
	SUBSTANTIALLY EQUIVALENT	3
BIO2 TECHNOLOGIES, INC
	SUBSTANTIALLY EQUIVALENT	1
BIO2 TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOCOMPOSITES LTD
	SUBSTANTIALLY EQUIVALENT	1
BIOCOMPOSITES LTD.
	SUBSTANTIALLY EQUIVALENT	1
BIOGENNIX
	SUBSTANTIALLY EQUIVALENT	1
BIOGENNIX, LLC
	SUBSTANTIALLY EQUIVALENT	3
BIOGENNIX, LLC.
	SUBSTANTIALLY EQUIVALENT	2
BIOMET SPINE
	SUBSTANTIALLY EQUIVALENT	1
BIOSTONE LTD
	SUBSTANTIALLY EQUIVALENT	1
BIOSTRUCTURES
	SUBSTANTIALLY EQUIVALENT	1
BIOSTRUCTURES, LLC
	SUBSTANTIALLY EQUIVALENT	4
BIOVENTUS
	SUBSTANTIALLY EQUIVALENT	1
BIOVENTUS LLC
	SUBSTANTIALLY EQUIVALENT	2
BONALIVE BIOMATERIALS LTD.
	SUBSTANTIALLY EQUIVALENT	1
BONALIVE BIOMATERIALS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
BONE SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	4
BONESUPPORT AB
	SUBSTANTIALLY EQUIVALENT	3
CELLUMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
COLLAGEN MATRIX, INC.
	SUBSTANTIALLY EQUIVALENT	5
CONVERG ENGINEERING
	SUBSTANTIALLY EQUIVALENT	1
CORLIBER (SHENZHEN) MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CURASAN AG
	SUBSTANTIALLY EQUIVALENT	3
CYTOPHIL INC
	SUBSTANTIALLY EQUIVALENT	1
DIMENSIONAL BIOCERAMICS LLC
	SUBSTANTIALLY EQUIVALENT	1
DIMENSIONAL BIOCERAMICS, LLC
	SUBSTANTIALLY EQUIVALENT	2
DIMENSIONAL BIOCERAMICS, LLC.
	SUBSTANTIALLY EQUIVALENT	1
DSM BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ED. GEISTLICH SOEHNE AG FUR CHEMISCHE INDUSTRIE
	SUBSTANTIALLY EQUIVALENT	1
ELUTE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ETEX CORP.
	SUBSTANTIALLY EQUIVALENT	6
ETEX CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
GEISTLICH PHARMA AG
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	3
GLOBUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
GRAFTYS
	SUBSTANTIALLY EQUIVALENT	3
HAIDER BIOLOGICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
HANS BIOMED CORP.
	SUBSTANTIALLY EQUIVALENT	2
HANS BIOMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
HOYA CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INION OY
	SUBSTANTIALLY EQUIVALENT	2
INTEGRA LIFESCIENCE CORPORTATION
	SUBSTANTIALLY EQUIVALENT	1
INTEGRA LIFESCIENCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INTRA-LOCK INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ISTO TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
KASIOS
	SUBSTANTIALLY EQUIVALENT	1
KENSEY NASH CORORATION
	SE - WITH LIMITATIONS	1
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	2
KUROS BIOSCIENCES B.V.
	SUBSTANTIALLY EQUIVALENT	8
KUROS BIOSCIENCES BV
	SUBSTANTIALLY EQUIVALENT	2
LINACOL MUH DAN KIM CEV TEK MED ITH IHR SAN VE TIC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC SOFAMOR DANEK USA, INC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	3
MEDTRONIC SOFAMOR DANEK, INC.
	SUBSTANTIALLY EQUIVALENT	2
MOLECULAR MATRIX, INC.
	SUBSTANTIALLY EQUIVALENT	1
MUSCULOSKELETAL TRANSPLANT FOUNDATION
	SUBSTANTIALLY EQUIVALENT	6
NANOTHERAPEUTICS
	SUBSTANTIALLY EQUIVALENT	1
NANOTHERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
NOVABONE PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	10
NUVASIVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	2
ORIENTAL RESOURCES DEVELOPMENT LIMITED
	SUBSTANTIALLY EQUIVALENT	1
ORTHOCON, INC.
	SUBSTANTIALLY EQUIVALENT	3
ORTHOGEM LIMITED
	SUBSTANTIALLY EQUIVALENT	1
ORTHOGEM LTD
	SUBSTANTIALLY EQUIVALENT	1
ORTHOREBIRTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
ORTHOVITA, INC.
	SUBSTANTIALLY EQUIVALENT	5
OSSDSIGN AB
	SUBSTANTIALLY EQUIVALENT	1
OSTEONOVUS, INC.
	SUBSTANTIALLY EQUIVALENT	2
PIONEER SURGICAL TECHNOLOGY
	SUBSTANTIALLY EQUIVALENT	4
PIONEER SURGICAL TECHNOLOGY, INC
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I
	SUBSTANTIALLY EQUIVALENT	1
PROGENTIX ORTHOBIOLOGY B.V.
	SUBSTANTIALLY EQUIVALENT	2
PROSIDYAN INC.
	SUBSTANTIALLY EQUIVALENT	1
PROSIDYAN, INC
	SUBSTANTIALLY EQUIVALENT	7
PROSIDYAN, INC.
	SUBSTANTIALLY EQUIVALENT	1
SBM SCIENCES FOR BIO MATERIALS
	SUBSTANTIALLY EQUIVALENT	1
SEASPINE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
SIGNUS MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
SIRAKOSS LTD.
	SUBSTANTIALLY EQUIVALENT	1
SKELETAL KINETICS, LLC
	SUBSTANTIALLY EQUIVALENT	4
SPINESMITH PARTNERS, LLP
	SUBSTANTIALLY EQUIVALENT	1
SURGENTEC, LLC
	SUBSTANTIALLY EQUIVALENT	2
SYNERGY BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	1
SYNERGY BIOMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SYNERGY BIOMEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
SYNTHES USA PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	1
TCM ASSOCIATES LTD
	SUBSTANTIALLY EQUIVALENT	1
VENTRIS MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
VIVORTE, INC
	SUBSTANTIALLY EQUIVALENT	2
WILTROM CORPORATION LIMITED
	SUBSTANTIALLY EQUIVALENT	3
WRIGHT MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	10
XENCO MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
XPAND BIOTECHNOLOGY BV
	SUBSTANTIALLY EQUIVALENT	1
ZAVATION MEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER BIOMET SPINE INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER KNEE CREATIONS
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	109	109
2015	124	124
2016	105	105
2017	106	106
2018	85	85
2019	65	65
2020	126	126
2021	101	101
2022	47	47
2023	120	120
2024	15	15

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	398	398
Insufficient Information	137	137
Break	74	74
Device Operates Differently Than Expected	49	49
Fracture	33	33
Appropriate Term/Code Not Available	33	33
Migration or Expulsion of Device	32	32
Chemical Problem	22	22
Use of Device Problem	22	22
Migration	22	22
Failure to Eject	20	20
Patient-Device Incompatibility	19	19
No Apparent Adverse Event	18	18
Device Expiration Issue	14	14
Shelf Life Exceeded	12	12
Improper or Incorrect Procedure or Method	12	12
Failure to Osseointegrate	11	11
Device Inoperable	9	9
Device Difficult to Setup or Prepare	8	8
Difficult to Insert	7	7
Leak/Splash	7	7
Expiration Date Error	7	7
Crack	6	6
Fluid/Blood Leak	6	6
Compatibility Problem	6	6
Material Integrity Problem	5	5
Device Markings/Labelling Problem	5	5
Collapse	5	5
Loose or Intermittent Connection	5	5
Material Too Rigid or Stiff	5	5
Malposition of Device	5	5
Tear, Rip or Hole in Device Packaging	4	4
Coagulation in Device or Device Ingredient	4	4
Positioning Problem	4	4
Patient Device Interaction Problem	4	4
Material Protrusion/Extrusion	4	4
Device Dislodged or Dislocated	4	4
Human Factors Issue	3	3
No Flow	3	3
Packaging Problem	3	3
Contamination	3	3
Failure To Adhere Or Bond	3	3
Material Disintegration	3	3
Filling Problem	3	3
Fitting Problem	3	3
Sticking	3	3
Difficult to Open or Close	3	3
Difficult to Open or Remove Packaging Material	3	3
Contamination of Device Ingredient or Reagent	3	3
Biocompatibility	2	2
Defective Device	2	2
Device Ingredient or Reagent Problem	2	2
Metal Shedding Debris	2	2
Failure to Deliver	2	2
Failure to Advance	2	2
Clumping in Device or Device Ingredient	2	2
Loss of or Failure to Bond	2	2
Difficult to Remove	2	2
Material Separation	2	2
Inadequacy of Device Shape and/or Size	2	2
Device Slipped	2	2
Inadequate Instructions for Healthcare Professional	2	2
Nonstandard Device	2	2
Osseointegration Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Material Distortion	1	1
Output Problem	1	1
Physical Property Issue	1	1
Human-Device Interface Problem	1	1
Improper Chemical Reaction	1	1
Inadequate User Interface	1	1
Device Contamination with Chemical or Other Material	1	1
Device Contaminated During Manufacture or Shipping	1	1
Material Too Soft/Flexible	1	1
Unintended Movement	1	1
Off-Label Use	1	1
Mechanical Problem	1	1
Unstable	1	1
Material Rupture	1	1
Bent	1	1
Unintended Ejection	1	1
Difficult or Delayed Positioning	1	1
Positioning Failure	1	1
Hole In Material	1	1
Split	1	1
Inaccurate Delivery	1	1
High Test Results	1	1
Failure to Align	1	1
Volume Accuracy Problem	1	1
Defective Component	1	1
Microbial Contamination of Device	1	1
Component Missing	1	1
Computer Operating System Problem	1	1
Device Packaging Compromised	1	1
Device Sensing Problem	1	1
Device Or Device Fragments Location Unknown	1	1
Charging Problem	1	1
Delivery System Failure	1	1
Activation, Positioning or Separation Problem	1	1
Detachment of Device or Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	141	141
Unspecified Infection	124	124
No Known Impact Or Consequence To Patient	119	119
No Code Available	84	84
No Clinical Signs, Symptoms or Conditions	62	62
Non-union Bone Fracture	47	47
Swelling	41	41
No Information	38	38
Post Operative Wound Infection	37	37
No Consequences Or Impact To Patient	34	34
Injury	34	34
Hematoma	34	34
Failure of Implant	31	31
Swelling/ Edema	28	28
Bone Fracture(s)	27	27
Impaired Healing	25	25
Insufficient Information	24	24
Inflammation	21	21
Reaction	17	17
Fluid Discharge	16	16
Skin Discoloration	16	16
Bacterial Infection	16	16
Erythema	16	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	16	16
Nerve Damage	15	15
Seroma	13	13
Unspecified Tissue Injury	13	13
Death	12	12
Arthritis	10	10
Foreign Body In Patient	10	10
No Patient Involvement	9	9
Numbness	9	9
Discomfort	9	9
Wound Dehiscence	9	9
Necrosis	9	9
Neurological Deficit/Dysfunction	8	8
Cerebrospinal Fluid Leakage	8	8
Fever	8	8
Ambulation Difficulties	8	8
Hypersensitivity/Allergic reaction	7	7
Paralysis	6	6
Cyst(s)	6	6
Dysphagia/ Odynophagia	6	6
Staphylococcus Aureus	6	6
Renal Failure	5	5
Weakness	5	5
Inadequate Osseointegration	5	5
Osteolysis	5	5
Fistula	5	5
Foreign Body Reaction	5	5
Embolism	5	5
Skin Infection	5	5
Edema	4	4
Ossification	4	4
Local Reaction	4	4
Inadequate Pain Relief	4	4
Test Result	4	4
Device Embedded In Tissue or Plaque	4	4
Scar Tissue	4	4
Tingling	4	4
Rupture	3	3
Therapeutic Response, Decreased	3	3
Respiratory Distress	3	3
Thrombosis	3	3
Decreased Sensitivity	3	3
Joint Dislocation	3	3
Depression	3	3
Neuropathy	3	3
Irritation	3	3
Itching Sensation	3	3
Incontinence	3	3
Infiltration into Tissue	3	3
Fatigue	3	3
Headache	3	3
Pulmonary Embolism	3	3
Bruise/Contusion	3	3
Abscess	3	3
Joint Laxity	3	3
Implant Pain	3	3
Skin Inflammation/ Irritation	2	2
Eczema	2	2
Thrombosis/Thrombus	2	2
Unspecified Respiratory Problem	2	2
Purulent Discharge	2	2
Dyspnea	2	2
Emotional Changes	2	2
Foreign Body Sensation in Eye	2	2
Cardiac Arrest	2	2
Stroke/CVA	2	2
Autoimmune Disorder	2	2
Bradycardia	2	2
Hepatitis	2	2
Fall	2	2
High Blood Pressure/ Hypertension	2	2
Loss of Range of Motion	2	2
Fungal Infection	2	2
Patient Problem/Medical Problem	2	2
Fibrosis	2	2
Burning Sensation	2	2
Ulceration	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Acumed LLC	II	Aug-23-2017
2	AlloSource, Inc.	II	May-06-2014
3	Apatech Limited	II	Jun-07-2016
4	Biocomposites, Ltd.	II	Dec-18-2020
5	Biostructures, LLC	II	Mar-16-2011
6	Bioventus, LLC	II	Apr-15-2019
7	Exactech, Inc.	II	May-29-2019
8	Globus Medical, Inc.	II	Oct-31-2013
9	Howmedica Osteonics Corp.	II	Dec-22-2018
10	Integra LifeSciences Corp	II	Feb-08-2012
11	Integra LifeSciences Corp	II	Mar-06-2009
12	Integra LifeSciences Corp.	II	Jun-12-2012
13	Medtronic Sofamor Danek USA Inc	II	Sep-08-2023
14	Musculoskeletal Transplant Foundation, Inc.	II	Feb-09-2024
15	Musculoskeletal Transplant Foundation, Inc.	II	Nov-17-2023
16	Musculoskeletal Transplant Foundation, Inc.	II	May-12-2021
17	Musculoskeletal Transplant Foundation, Inc.	II	Apr-17-2015
18	Nanotherapeutics, Inc	II	Dec-02-2011
19	Osteomed, LLC	II	May-29-2020
20	RTI Biologics, Inc.	II	Jun-23-2011
21	RTI Surgical, Inc.	II	Mar-10-2017
22	RTI Surgical, Inc.	II	Feb-07-2014
23	Skeletal Kinetics, Llc	II	Jul-15-2020
24	Skeletal Kinetics, Llc	II	Jul-24-2015
25	Surgical Tissue Network, Inc.	II	Jan-07-2013
26	Synthes (USA) Products LLC	II	Jun-09-2016
27	Synthes USA	II	Feb-15-2018
28	Synthes USA	II	Jan-11-2012
29	Theken Spine LLC	II	Sep-03-2009