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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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

MDR Year MDR Reports MDR Events
2018 9 9
2019 3 3
2020 6 6
2021 2 2
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 6 6
Adverse Event Without Identified Device or Use Problem 4 4
Inaccurate Information 3 3
Labelling, Instructions for Use or Training Problem 3 3
Device Markings/Labelling Problem 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Product Quality Problem 2 2
No Apparent Adverse Event 2 2
Insufficient Information 1 1
Material Fragmentation 1 1
Improper or Incorrect Procedure or Method 1 1
Component Missing 1 1
Expiration Date Error 1 1
Patient-Device Incompatibility 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bacterial Infection 7 7
Unspecified Infection 3 3
No Known Impact Or Consequence To Patient 3 3
Device Embedded In Tissue or Plaque 2 2
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Patient Problem/Medical Problem 2 2
Bone Fracture(s) 2 2
Hypersensitivity/Allergic reaction 2 2
Failure of Implant 2 2
Damage to Ligament(s) 2 2
Muscle Weakness 1 1
No Consequences Or Impact To Patient 1 1
Spinal Cord Injury 1 1
Fever 1 1
Nervous System Injury 1 1
Inflammation 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Vivorte, Inc. II Jul-07-2021
2 Wright Medical Technology, Inc. II Nov-25-2019
3 XTANT MEDICAL INC II Mar-19-2020
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