TPLC - Total Product Life Cycle

• Device: filler, bone void, osteoinduction (w/o human growth factor)
• Product Code: MBP
• Regulation Number: 888.3045
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BACTERIN INTERNATIONAL INC.
	SUBSTANTIALLY EQUIVALENT	1
HANS BIOMED CORP.
	SUBSTANTIALLY EQUIVALENT	1
INTEGRA LIFESCIENCES
	SUBSTANTIALLY EQUIVALENT	1
ISOTIS ORTHOBIOLOGICS, INC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK, INC.
	SUBSTANTIALLY EQUIVALENT	1
VIVORTE, INC
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2014	14	14
2015	11	11
2016	6	6
2017	5	5
2018	9	9
2019	3	3
2020	6	6
2021	2	2
2022	4	4
2023	6	6
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	18	18
Insufficient Information	11	11
Microbial Contamination of Device	7	7
Inaccurate Information	4	4
Device Markings/Labelling Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Patient-Device Incompatibility	3	3
Labelling, Instructions for Use or Training Problem	3	3
Device Expiration Issue	2	2
Product Quality Problem	2	2
Shelf Life Exceeded	2	2
Use of Device Problem	2	2
Expiration Date Error	2	2
Device Disinfection Or Sterilization Issue	2	2
No Apparent Adverse Event	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Device Handling Problem	1	1
Device Operates Differently Than Expected	1	1
Device Packaging Compromised	1	1
Biocompatibility	1	1
Inaudible or Unclear Audible Prompt/Feedback	1	1
Component Missing	1	1
Out-Of-Box Failure	1	1
Contamination	1	1
Shipping Damage or Problem	1	1
Material Fragmentation	1	1
Unsealed Device Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	14	14
No Known Impact Or Consequence To Patient	12	12
Bacterial Infection	8	8
Pain	7	7
Purulent Discharge	6	6
No Clinical Signs, Symptoms or Conditions	4	4
No Consequences Or Impact To Patient	4	4
Post Operative Wound Infection	3	3
Patient Problem/Medical Problem	3	3
Swelling/ Edema	3	3
Erythema	3	3
Hematoma	2	2
Hepatitis	2	2
Hypersensitivity/Allergic reaction	2	2
Paralysis	2	2
Nerve Damage	2	2
Neurological Deficit/Dysfunction	2	2
Neuropathy	2	2
Renal Failure	2	2
Fever	2	2
Bone Fracture(s)	2	2
Damage to Ligament(s)	2	2
Insufficient Information	2	2
Device Embedded In Tissue or Plaque	2	2
No Information	2	2
Osteolysis	2	2
Swelling	2	2
Failure of Implant	2	2
Dysphasia	2	2
Urinary Tract Infection	1	1
Vomiting	1	1
Stenosis	1	1
Complaint, Ill-Defined	1	1
Injury	1	1
Disability	1	1
Impaired Healing	1	1
Numbness	1	1
Fungal Infection	1	1
Spinal Cord Injury	1	1
Neck Stiffness	1	1
Sleep Dysfunction	1	1
Ambulation Difficulties	1	1
No Patient Involvement	1	1
Tissue Breakdown	1	1
Dysuria	1	1
Unspecified Immune System Problem	1	1
Unspecified Respiratory Problem	1	1
Nervous System Injury	1	1
Muscle Spasm(s)	1	1
Muscle Weakness	1	1
Nausea	1	1
Headache	1	1
Inflammation	1	1
Spinal Column Injury	1	1
Loss of Range of Motion	1	1
Renal Disease, End Stage	1	1
High Blood Pressure/ Hypertension	1	1
Fall	1	1
Abscess	1	1
Rheumatoid Arthritis	1	1
Autoimmune Disorder	1	1
Dysphagia/ Odynophagia	1	1
Dyspnea	1	1
Emotional Changes	1	1
Erosion	1	1
Cellulitis	1	1
Contusion	1	1
Death	1	1
Diarrhea	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Bacterin International, Inc.	II	Apr-17-2013
2	Bacterin International, Inc.	II	Feb-11-2013
3	Integra LifeSciences Corp.	II	Jun-25-2014
4	Medtronic Sofamor Danek USA Inc	II	Oct-25-2023
5	Medtronic Sofamor Danek USA Inc	II	Apr-04-2023
6	Medtronic Sofamor Danek USA Inc	II	Feb-12-2014
7	Musculoskeletal Transplant Foundation, Inc.	II	Jun-16-2016
8	Osteotech Inc	II	Oct-18-2012
9	Osteotech Inc	II	Jan-11-2012
10	Vivorte, Inc.	II	Jul-07-2021
11	Wright Medical Technology, Inc.	II	Nov-25-2019
12	XTANT MEDICAL INC	II	Mar-19-2020