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TPLC
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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
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