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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
MDR Year
MDR Reports
MDR Events
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
4
4
Inaccurate Information
4
4
Labelling, Instructions for Use or Training Problem
3
3
Device Markings/Labelling Problem
3
3
Manufacturing, Packaging or Shipping Problem
2
2
Expiration Date Error
2
2
Patient-Device Incompatibility
2
2
Improper or Incorrect Procedure or Method
2
2
No Apparent Adverse Event
2
2
Material Fragmentation
1
1
Microbial Contamination of Device
1
1
Component Missing
1
1
Unsealed Device Packaging
1
1
Biocompatibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4
4
No Known Impact Or Consequence To Patient
3
3
Swelling/ Edema
3
3
Insufficient Information
2
2
Patient Problem/Medical Problem
2
2
Device Embedded In Tissue or Plaque
2
2
Bone Fracture(s)
2
2
Hematoma
2
2
Hypersensitivity/Allergic reaction
2
2
Failure of Implant
2
2
Unspecified Infection
2
2
Damage to Ligament(s)
2
2
Muscle Weakness
1
1
Nerve Damage
1
1
Pain
1
1
Paralysis
1
1
Spinal Column Injury
1
1
No Consequences Or Impact To Patient
1
1
Impaired Healing
1
1
Fungal Infection
1
1
Spinal Cord Injury
1
1
Inflammation
1
1
Rheumatoid Arthritis
1
1
Autoimmune Disorder
1
1
Emotional Changes
1
1
Fever
1
1
Unspecified Immune System Problem
1
1
Unspecified Respiratory Problem
1
1
Nervous System Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Sofamor Danek USA Inc
II
Oct-25-2023
2
Medtronic Sofamor Danek USA Inc
II
Apr-04-2023
3
Vivorte, Inc.
II
Jul-07-2021
4
Wright Medical Technology, Inc.
II
Nov-25-2019
5
XTANT MEDICAL INC
II
Mar-19-2020
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